Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer

Julie Brahmer, Karen L. Reckamp, Paul Baas, Lucio Crinò, Wilfried E E Eberhardt, Elena Poddubskaya, Scott Antonia, Adam Pluzanski, Everett E. Vokes, Esther Holgado, David Waterhouse, Neal Ready, Justin Gainor, Osvaldo Arén Frontera, Libor Havel, Martin Steins, Marina C. Garassino, Joachim G. Aerts, Manuel Domine, Luis Paz-AresMartin Reck, Christine Baudelet, Christopher T. Harbison, Brian Lestini, David R. Spigel

Research output: Contribution to journalArticlepeer-review


BACKGROUND Patients with advanced squamous-cell non-small-cell lung cancer (NSCLC) who have disease progression during or after first-line chemotherapy have limited treatment options. This randomized, open-label, international, phase 3 study evaluated the efficacy and safety of nivolumab, a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor antibody, as compared with docetaxel in this patient population. METHODS We randomly assigned 272 patients to receive nivolumab, at a dose of 3 mg per kilogram of body weight every 2 weeks, or docetaxel, at a dose of 75 mg per square meter of body-surface area every 3 weeks. The primary end point was overall survival. RESULTS The median overall survival was 9.2 months (95% confidence interval [CI], 7.3 to 13.3) with nivolumab versus 6.0 months (95% CI, 5.1 to 7.3) with docetaxel. The risk of death was 41% lower with nivolumab than with docetaxel (hazard ratio, 0.59; 95% CI, 0.44 to 0.79; P

Original languageEnglish
Pages (from-to)123-135
Number of pages13
JournalNew England Journal of Medicine
Issue number2
Publication statusPublished - Jul 9 2015

ASJC Scopus subject areas

  • Medicine(all)


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