{"entity":{"id":"nct02486718","kind":"trial","name":"Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [","aka":["IMpower010"],"tldr":"A phase 3 trial of Atezolizumab, Cisplatin, Vinorelbine in non-small-cell lung cancer and small-cell lung cancer, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010] is a phase 3 interventional study registered as NCT02486718 by Hoffmann-La Roche, with 1280 participants enrolled, started 2015-10-31 and due to reach its primary completion in 2024-01-26. Interventions recorded: Atezolizumab, Cisplatin, Vinorelbine, Docetaxel, Gemcitabine. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"positive","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02486718","url":"https://clinicaltrials.gov/study/NCT02486718"},{"label":"IMpower010 (Lancet 2021)","url":"https://doi.org/10.1016/S0140-6736(21)02098-5"},{"label":"NICE TA1071: atezolizumab for adjuvant treatment of resected non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1071"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["atezolizumab","cisplatin","vinorelbine","docetaxel","gemcitabine","pemetrexed"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":["keynote-091","adaura","alina"],"people":[],"bottlenecks":[],"keyPapers":["paper-felip-impower010-adjuvant-atezolizumab-lancet-2021","paper-nct02486718-ann-oncol-2023-update"],"journals":[],"dependsOn":[],"notes":["IMpower010 enrolled 1,280 patients at 227 sites in 22 countries between October 2015 and September 2018; 1,269 received adjuvant platinum-based chemotherapy and 1,005 were randomised to atezolizumab 1200 mg every 21 days for 16 cycles or one year (507) or to best supportive care (498). Disease-free survival was tested hierarchically: first in the stage II to IIIA subgroup whose tumours expressed PD-L1 on 1 percent or more of tumour cells by the SP263 assay, then in all stage II to IIIA patients, then in the stage IB to IIIA intention-to-treat population (Lancet 2021)."],"nct":"NCT02486718","phase":"3","setting":"A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer","sponsor":"Hoffmann-La Roche","result":"IMpower010: adjuvant atezolizumab after platinum chemotherapy improved disease-free survival in resected stage II to IIIA non-small-cell lung cancer, most in tumours with PD-L1 on 1 percent or more of tumour cells (hazard ratio 0.66); approved in the United States in October 2021 for that group.","started":"2015-10-31","startedType":"actual","yearReported":2021,"enrolled":1280,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival, stage II to IIIA with PD-L1 on 1% or more of tumour cells","primary":true,"unit":"months","arms":[{"name":"Atezolizumab after adjuvant chemotherapy","value":68.5,"note":"Registry results, up to 95 months; 95% CI 51.8 to not reached"},{"name":"Best supportive care","value":37.3,"note":"95% CI 30.1 to 57.8"}],"hr":0.704,"ci":[0.545,0.91],"source":"https://clinicaltrials.gov/study/NCT02486718?tab=results"},{"endpoint":"Disease-free survival, all randomised stage II to IIIA","primary":true,"unit":"months","arms":[{"name":"Atezolizumab after adjuvant chemotherapy","value":57.4,"note":"95% CI 42.2 to not reached"},{"name":"Best supportive care","value":40.8,"note":"95% CI 31.4 to 57.1"}],"hr":0.83,"ci":[0.691,0.998],"source":"https://clinicaltrials.gov/study/NCT02486718?tab=results"},{"endpoint":"Disease-free survival, intention-to-treat population (stage IB to IIIA)","primary":true,"unit":"months","arms":[{"name":"Atezolizumab after adjuvant chemotherapy","n":507,"value":65.6,"note":"95% CI 52.4 to not reached"},{"name":"Best supportive care","n":498,"value":47.8,"note":"95% CI 37.0 to 65.8"}],"hr":0.848,"ci":[0.71,1.013],"p":"0.0683","source":"https://clinicaltrials.gov/study/NCT02486718?tab=results"},{"endpoint":"Disease-free survival at the primary analysis (Lancet 2021), stage II to IIIA with PD-L1 on 1% or more of tumour cells","arms":[{"name":"Atezolizumab after adjuvant chemotherapy","note":"Median follow-up 32.2 months"},{"name":"Best supportive care"}],"hr":0.66,"ci":[0.5,0.88],"p":"0.0039","source":"https://doi.org/10.1016/S0140-6736(21)02098-5"},{"endpoint":"Atezolizumab-related grade 3 to 4 adverse events","unit":"%","arms":[{"name":"Atezolizumab after adjuvant chemotherapy","n":495,"value":11,"note":"53 patients; grade 5 events in 4 (1%)"}],"source":"https://doi.org/10.1016/S0140-6736(21)02098-5"}],"replication":"KEYNOTE-091 found an adjuvant disease-free survival benefit for pembrolizumab in the whole population but not in the PD-L1-high subgroup, the opposite pattern."},"route":"/trials/nct02486718/","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":"resectable-nsclc","kind":"cancer","name":"Resectable stage I to III non-small-cell lung cancer","route":"/cancers/resectable-nsclc/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"}],"drug":[{"id":"atezolizumab","kind":"drug","name":"Atezolizumab","route":"/drugs/atezolizumab/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"pemetrexed","kind":"drug","name":"Pemetrexed","route":"/drugs/pemetrexed/"},{"id":"vinorelbine","kind":"drug","name":"Vinorelbine","route":"/drugs/vinorelbine/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"trial":[{"id":"adaura","kind":"trial","name":"ADAURA","route":"/trials/adaura/"},{"id":"alina","kind":"trial","name":"ALINA","route":"/trials/alina/"},{"id":"keynote-091","kind":"trial","name":"KEYNOTE-091 (PEARLS)","route":"/trials/keynote-091/"}],"paper":[{"id":"paper-felip-impower010-adjuvant-atezolizumab-lancet-2021","kind":"paper","name":"Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010)","route":"/key-papers/paper-felip-impower010-adjuvant-atezolizumab-lancet-2021/"},{"id":"paper-nct02486718-ann-oncol-2023-update","kind":"paper","name":"Overall survival with adjuvant atezolizumab after chemotherapy in resected stage II-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase III trial","route":"/key-papers/paper-nct02486718-ann-oncol-2023-update/"}]}}