Paz-Ares, LuisLuft, AlexanderVicente, DavidTafreshi, AliGümüş, MahmutMazières, JulienHermes, BarbaraÇay Şenler, FilizCsőszi, TiborFülöp, AndreaRodríguez-Cid, JerónimoWilson, JonathanSugawara, ShunichiKato, TerufumiLee, Ki HyeongCheng, YingNovello, SilviaHalmos, BalazsLi, XiaodongLubiniecki, Gregory MPiperdi, BilalKowalski, Dariusz MKEYNOTE-407 Investigators2023-01-252023-01-252018-09-25http://hdl.handle.net/10668/13017Standard first-line therapy for metastatic, squamous non-small-cell lung cancer (NSCLC) is platinum-based chemotherapy or pembrolizumab (for patients with programmed death ligand 1 [PD-L1] expression on ≥50% of tumor cells). More recently, pembrolizumab plus chemotherapy was shown to significantly prolong overall survival among patients with nonsquamous NSCLC. In this double-blind, phase 3 trial, we randomly assigned, in a 1:1 ratio, 559 patients with untreated metastatic, squamous NSCLC to receive 200 mg of pembrolizumab or saline placebo for up to 35 cycles; all the patients also received carboplatin and either paclitaxel or nanoparticle albumin-bound [nab]-paclitaxel for the first 4 cycles. Primary end points were overall survival and progression-free survival. After a median follow-up of 7.8 months, the median overall survival was 15.9 months (95% confidence interval [CI], 13.2 to not reached) in the pembrolizumab-combination group and 11.3 months (95% CI, 9.5 to 14.8) in the placebo-combination group (hazard ratio for death, 0.64; 95% CI, 0.49 to 0.85; P In patients with previously untreated metastatic, squamous NSCLC, the addition of pembrolizumab to chemotherapy with carboplatin plus paclitaxel or nab-paclitaxel resulted in significantly longer overall survival and progression-free survival than chemotherapy alone. (Funded by Merck Sharp & Dohme; KEYNOTE-407 ClinicalTrials.gov number, NCT02775435 .).enAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungDouble-Blind MethodFemaleHumansIntention to Treat AnalysisLung NeoplasmsMaleMiddle AgedPaclitaxelProgrammed Cell Death 1 ReceptorProgression-Free SurvivalSurvival Analysisresearch article30280635open access10.1056/NEJMoa18108651533-4406https://doi.org/10.1056/nejmoa1810865