{"entity":{"id":"paper-checkmate-017-nejm-2015","kind":"paper","name":"CheckMate 017: nivolumab beats docetaxel in squamous lung cancer after chemotherapy","aka":[],"tldr":"In squamous non-small-cell lung cancer that had progressed after platinum chemotherapy, the PD-1 antibody nivolumab prolonged life compared with docetaxel with far fewer severe side effects, regardless of PD-L1 status.","summary":"CheckMate 017 randomised 272 patients with advanced squamous non-small-cell lung cancer that had progressed during or after first-line platinum chemotherapy to nivolumab or docetaxel. Nivolumab improved overall survival, the primary endpoint, as well as response rate and progression-free survival, with a fraction of the grade 3 or 4 toxicity of docetaxel. Unlike its non-squamous companion trial CheckMate 057, the benefit did not depend on PD-L1 expression, which led to nivolumab's approval in squamous disease without a biomarker requirement.","asOf":"2026-09-08","links":[{"label":"Full text (DOI)","url":"https://doi.org/10.1056/NEJMoa1504627"},{"label":"ClinicalTrials.gov NCT01642004","url":"https://clinicaltrials.gov/study/NCT01642004"}],"tags":[],"related":["paper-checkmate-057-nejm-2015"],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":["pd1","pdl1"],"drugs":["nivolumab","docetaxel"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["os","orr"],"trials":[],"people":["julie-brahmer"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2015,"doi":"10.1056/NEJMoa1504627","authors":"Brahmer J, Reckamp KL, Baas P, et al.","paperType":"rct","findings":["272 patients with previously treated squamous NSCLC; nivolumab vs docetaxel.","Median overall survival 9.2 vs 6.0 months, hazard ratio 0.59; one-year survival 42% vs 24%.","Response rate 20% vs 9%; median progression-free survival 3.5 vs 2.8 months, hazard ratio 0.62.","Grade 3 or 4 treatment-related adverse events 7% vs 55%; benefit was independent of PD-L1 expression."],"whatItMeans":"With CheckMate 057 this trial ended docetaxel's role as the default second-line treatment in lung cancer and gave the first phase 3 proof that PD-1 blockade extends life in a common carcinoma. Its PD-L1-independent benefit in squamous disease still shapes how the biomarker is used.","caveats":["Open-label design.","Second-line setting; first-line immunotherapy has since changed who reaches this point.","Squamous histology only."],"changedPractice":true,"participants":272},"route":"/key-papers/paper-checkmate-017-nejm-2015/","neighbours":{"paper":[{"id":"paper-checkmate-057-nejm-2015","kind":"paper","name":"CheckMate 057: nivolumab beats docetaxel after chemotherapy in non-squamous lung cancer","route":"/key-papers/paper-checkmate-057-nejm-2015/"}],"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"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":"orr","kind":"term","name":"Objective response rate (ORR)","route":"/terms/orr/"},{"id":"os","kind":"term","name":"Overall survival (OS)","route":"/terms/os/"}],"person":[{"id":"julie-brahmer","kind":"person","name":"Julie R. Brahmer","route":"/people/julie-brahmer/"}],"roadmap":[{"id":"lung-cancer-evidence-roadmap","kind":"roadmap","name":"Lung cancer roadmap: from Doll and Hill and the naming of tobacco, through the cytotoxic plateau, computed tomography screening, EGFR and ALK, immunotherapy by PD-L1, the perioperative trials and PACIFIC, to DLL3 in small-cell disease and a 2032 registry watch","route":"/roadmaps/lung-cancer-evidence-roadmap/"}],"idea":[{"id":"idea-tr1-low-dose-immunotherapy-for-lmic","kind":"idea","name":"Confirm ultra-low-dose immunotherapy so it can be afforded where most patients live","route":"/ideas/idea-tr1-low-dose-immunotherapy-for-lmic/"},{"id":"idea-cost-subcutaneous-community","kind":"idea","name":"Give subcutaneous immunotherapy in community clinics and at home","route":"/ideas/idea-cost-subcutaneous-community/"},{"id":"idea-cost-extended-interval-default","kind":"idea","name":"Make six-weekly immunotherapy the default schedule","route":"/ideas/idea-cost-extended-interval-default/"},{"id":"idea-reg-weight-based-io-dosing-label","kind":"idea","name":"Restore weight-based dosing and vial sharing for immunotherapy in the label","route":"/ideas/idea-reg-weight-based-io-dosing-label/"}]}}