{"entity":{"id":"nct03381274","kind":"trial","name":"Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study","aka":[],"tldr":"A phase 1/2 trial of Oleclumab and Osimertinib in non-small-cell lung cancer, run by MedImmune LLC, active and no longer recruiting.","summary":"Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study is a phase 1/2 interventional study registered as NCT03381274 by MedImmune LLC, with 43 participants enrolled, started 2018-05-08 and due to reach its primary completion in 2021-05-24. Interventions recorded: Oleclumab, Osimertinib and AZD4635. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03381274","url":"https://clinicaltrials.gov/study/NCT03381274"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["oleclumab","osimertinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03381274-j-thorac-oncol-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03381274","phase":"1/2","setting":"A Multiarm, Open-label, Multicenter, Phase 1b/2 Study to Evaluate Novel Combination Therapies in Subjects With Previously Treated Advanced EGFRm NSCLC","sponsor":"MedImmune LLC","started":"2018-05-08","startedType":"actual","yearReported":2022,"enrolled":43,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Objective Response (OR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in Part 2","primary":true,"unit":"%","arms":[{"name":"Oleclumab Dose 2 + Osimertinib Dose 1","n":21,"value":19,"note":"95% CI 5.4 to 41.9; Figures from the ClinicalTrials.gov results section (first posted 2022-07-26), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03381274?tab=results"},{"endpoint":"Overall Survival (OS) for Parts 1 and 2","unit":"months","arms":[{"name":"Oleclumab Dose 1 + Osimertinib Dose 1","n":5,"value":21.9,"note":"95% CI 1.4 to NA; Figures from the ClinicalTrials.gov results section (first posted 2022-07-26), not from a publication"},{"name":"Oleclumab Dose 2 + Osimertinib Dose 1","n":21,"value":24.8,"note":"95% CI 12.3 to NA"},{"name":"Oleclumab Dose 1 + AZD4635 Dose 1","n":6,"value":16.4,"note":"95% CI 1.0 to 16.4"},{"name":"Oleclumab Dose 1 + AZD4635 Dose 2","n":6,"value":27.4,"note":"95% CI 1.5 to NA"},{"name":"Oleclumab Dose 2 + AZD4635 Dose 2","n":5,"value":7.1,"note":"95% CI 1.9 to NA"}],"source":"https://clinicaltrials.gov/study/NCT03381274?tab=results"},{"endpoint":"Progression Free Survival (PFS) for Parts 1 and 2","unit":"months","arms":[{"name":"Oleclumab Dose 1 + Osimertinib Dose 1","n":5,"value":6.5,"note":"95% CI 1.4 to 19.8; Figures from the ClinicalTrials.gov results section (first posted 2022-07-26), not from a publication"},{"name":"Oleclumab Dose 2 + Osimertinib Dose 1","n":21,"value":11,"note":"95% CI 3.7 to NA"},{"name":"Oleclumab Dose 1 + AZD4635 Dose 1","n":6,"value":1.4,"note":"95% CI 0.5 to 1.8"},{"name":"Oleclumab Dose 1 + AZD4635 Dose 2","n":6,"value":1.8,"note":"95% CI 0.8 to 5.5"},{"name":"Oleclumab Dose 2 + AZD4635 Dose 2","n":5,"value":1.9,"note":"95% CI 1.4 to 2.3"}],"source":"https://clinicaltrials.gov/study/NCT03381274?tab=results"}]},"route":"/trials/nct03381274/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"drug":[{"id":"oleclumab","kind":"drug","name":"Oleclumab","route":"/drugs/oleclumab/"},{"id":"osimertinib","kind":"drug","name":"Osimertinib","route":"/drugs/osimertinib/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"paper":[{"id":"paper-nct03381274-j-thorac-oncol-2023","kind":"paper","name":"CD73 Inhibitor Oleclumab Plus Osimertinib in Previously Treated Patients With Advanced T790M-Negative EGFR-Mutated NSCLC: A Brief Report","route":"/key-papers/paper-nct03381274-j-thorac-oncol-2023/"}]}}