{"entity":{"id":"checkmate-017","kind":"trial","name":"CheckMate 017","aka":[],"tldr":"The first trial to show that a PD-1 antibody beats chemotherapy in lung cancer, and it did so in squamous disease, for which almost nothing had worked.","summary":"Squamous non-small-cell lung cancer that has progressed after platinum chemotherapy had almost no options: docetaxel gave a median survival of six months and a miserable toxicity profile. CheckMate 017 randomised 272 such patients to nivolumab 3 mg/kg every two weeks or docetaxel 75 mg/m2 every three weeks, with overall survival as the primary endpoint.\n\nMedian overall survival was 9.2 months (95 percent confidence interval 7.3 to 13.3) with nivolumab against 6.0 months (5.1 to 7.3) with docetaxel, a 41 percent reduction in the risk of death (hazard ratio 0.59, 0.44 to 0.79). Response rate and progression-free survival also favoured nivolumab, and the effect held regardless of PD-L1 expression level, which is unusual and specific to the squamous population.\n\nThe FDA approved nivolumab for squamous non-small-cell lung cancer in 2015 on this trial. In England NICE TA655 (21 October 2020) recommends nivolumab for advanced squamous disease after chemotherapy. CheckMate 017 and CheckMate 057, published months apart, are the pair that made checkpoint inhibition standard second-line care in lung cancer before it moved to first line.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01642004","url":"https://clinicaltrials.gov/study/NCT01642004"},{"label":"CheckMate 017 (New England Journal of Medicine 2015)","url":"https://doi.org/10.1056/NEJMoa1504627"},{"label":"NICE TA655: nivolumab for advanced squamous non-small-cell lung cancer after chemotherapy","url":"https://www.nice.org.uk/guidance/ta655"}],"tags":[],"related":[],"cancers":["lung-squamous-cell-carcinoma","nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":["pd1","pdl1"],"drugs":["nivolumab","docetaxel"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["immune-checkpoint","tps","pd-l1-testing"],"trials":["checkmate-057","oak"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01642004","phase":"3","setting":"Advanced squamous non-small-cell lung cancer progressing during or after first-line chemotherapy: nivolumab 3 mg/kg every two weeks versus docetaxel 75 mg/m2 every three weeks, with overall survival as the primary endpoint","sponsor":"Bristol-Myers Squibb","result":"Median overall survival 9.2 against 6.0 months (hazard ratio 0.59, 95 percent confidence interval 0.44 to 0.79), independent of PD-L1 level.","yearReported":2015,"enrolled":272,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab","n":135,"value":9.2},{"name":"Docetaxel","n":137,"value":6}],"hr":0.59,"ci":[0.44,0.79],"source":"https://doi.org/10.1056/NEJMoa1504627"}],"replication":"CheckMate 057 (non-squamous), OAK (atezolizumab) and KEYNOTE-010 (pembrolizumab) all reproduced the second-line survival benefit against docetaxel."},"route":"/trials/checkmate-017/","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":"lung-squamous-cell-carcinoma","kind":"cancer","name":"Squamous cell carcinoma of the lung","route":"/cancers/lung-squamous-cell-carcinoma/"}],"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/"}],"target":[{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"},{"id":"pdl1","kind":"target","name":"PD-L1","route":"/targets/pdl1/"}],"drug":[{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"},{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}],"term":[{"id":"immune-checkpoint","kind":"term","name":"Immune checkpoint","route":"/terms/immune-checkpoint/"},{"id":"pd-l1-testing","kind":"term","name":"PD-L1 expression testing (22C3, SP142, SP263)","route":"/terms/pd-l1-testing/"},{"id":"tps","kind":"term","name":"Tumour proportion score (TPS)","route":"/terms/tps/"}],"trial":[{"id":"checkmate-057","kind":"trial","name":"CheckMate 057","route":"/trials/checkmate-057/"},{"id":"keynote-010","kind":"trial","name":"KEYNOTE-010","route":"/trials/keynote-010/"},{"id":"oak","kind":"trial","name":"OAK","route":"/trials/oak/"}]}}