{"entity":{"id":"nct03164616","kind":"trial","name":"Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).","aka":["POSEIDON"],"tldr":"A phase 3 trial of Durvalumab, Tremelimumab, Paclitaxel / nab-paclitaxel in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON). is a phase 3 interventional study registered as NCT03164616 by AstraZeneca, with 1186 participants enrolled, started 2017-06-01 and due to reach its primary completion in 2021-03-12. Interventions recorded: Durvalumab, Tremelimumab, Abraxane + carboplatin, Gemcitabine + cisplatin, Gemcitabine + carboplatin. Conditions listed: Non Small Cell Lung Cancer NSCLC. Results were posted on ClinicalTrials.gov in 2022; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03164616","url":"https://clinicaltrials.gov/study/NCT03164616"},{"label":"POSEIDON (Journal of Clinical Oncology 2023)","url":"https://doi.org/10.1200/JCO.22.00975"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab","paclitaxel","carboplatin","gemcitabine","cisplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":["checkmate-9la","checkmate-227","nct02453282","nct02542293"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["POSEIDON randomised 1,013 patients with EGFR and ALK wild-type metastatic non-small-cell lung cancer 1:1:1 to tremelimumab 75 mg with durvalumab 1,500 mg and platinum chemotherapy for up to four 21-day cycles then durvalumab every four weeks with one further tremelimumab dose; to durvalumab with chemotherapy then durvalumab; or to chemotherapy alone for up to six cycles. Progression-free survival for durvalumab with chemotherapy against chemotherapy was 5.5 against 4.8 months (hazard ratio 0.74, 95 percent confidence interval 0.62 to 0.89, p=0.0009) and overall survival 13.3 against 11.7 months (0.86, 0.72 to 1.02, p=0.0758, not significant). Adding tremelimumab gave progression-free survival 6.2 against 4.8 months (0.72, 0.60 to 0.86, p=0.0003) and overall survival 14.0 against 11.7 months (0.77, 0.65 to 0.92, p=0.0030), with 24-month overall survival 32.9 against 22.1 percent. Maximum grade 3 or 4 treatment-related events occurred in 51.8, 44.6 and 44.4 percent respectively (Journal of Clinical Oncology 2023). There is no NICE recommendation for either POSEIDON regimen."],"nct":"NCT03164616","phase":"3","setting":"A Phase III, Randomized, Multi-Center, Open-Label, Comparative Global Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for First-Line Treatment in Patients With Metastatic Non Small-Cell Lung Cancer (NSCLC) (POSEIDON)","sponsor":"AstraZeneca","result":"Durvalumab with chemotherapy improved progression-free survival (5.5 against 4.8 months, hazard ratio 0.74, p=0.0009) but not significantly overall survival; adding a limited course of tremelimumab improved both (overall survival 14.0 against 11.7 months, hazard ratio 0.77, p=0.0030).","started":"2017-06-01","startedType":"actual","yearReported":2022,"enrolled":1186,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-Free Survival (PFS); D + SoC Compared With SoC Alone","primary":true,"unit":"months","arms":[{"name":"D + SoC","n":338,"value":5.5,"note":"95% CI 4.7 to 6.5; Figures from the ClinicalTrials.gov results section (first posted 2022-04-07), not from a publication"},{"name":"SoC Alone","n":337,"value":4.8,"note":"95% CI 4.6 to 5.8"}],"hr":0.74,"ci":[0.62,0.885],"p":"0.00093","source":"https://clinicaltrials.gov/study/NCT03164616?tab=results"},{"endpoint":"Overall Survival (OS); D + SoC Compared With SoC Alone","primary":true,"unit":"months","arms":[{"name":"D + SoC","n":338,"value":13.3,"note":"95% CI 11.4 to 14.7; Figures from the ClinicalTrials.gov results section (first posted 2022-04-07), not from a publication"},{"name":"SoC Alone","n":337,"value":11.7,"note":"95% CI 10.5 to 13.1"}],"hr":0.86,"ci":[0.724,1.016],"p":"0.07581","source":"https://clinicaltrials.gov/study/NCT03164616?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"T + D + SoC","n":335,"value":46.3,"note":"Figures from the ClinicalTrials.gov results section (first posted 2022-04-07), not from a publication"},{"name":"D + SoC","n":330,"value":48.5},{"name":"SoC Alone","n":332,"value":33.4}],"source":"https://clinicaltrials.gov/study/NCT03164616?tab=results"}]},"route":"/trials/nct03164616/","neighbours":{"cancer":[{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"},{"id":"tremelimumab","kind":"drug","name":"Tremelimumab","route":"/drugs/tremelimumab/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"trial":[{"id":"checkmate-227","kind":"trial","name":"CheckMate 227","route":"/trials/checkmate-227/"},{"id":"checkmate-9la","kind":"trial","name":"CheckMate 9LA","route":"/trials/checkmate-9la/"},{"id":"nct02453282","kind":"trial","name":"Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)","route":"/trials/nct02453282/"},{"id":"nct02542293","kind":"trial","name":"Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)","route":"/trials/nct02542293/"}]}}