6/28/23, 12:26 AM CheckMate-057 Pathway Feedback Search Clinical Topics Home Studies CheckMate-057 CheckMate-057 Disease Non-small cell lung cancer Trial question What is the role of nivolumab in patients with advanced non-squamous non-small cell lung cancer? Study design Multi-center Open label RCT Population Characteristics of study participants 45.0% female N = 582 55.0% male 582 patients (263 female, 319 male) Inclusion criteria: patients with non-squamous non-small cell lung cancer that had progressed during or after platinum-based doublet chemotherapy Key exclusion criteria: autoimmune disease, symptomatic ILD, systemic immunosuppression, prior treatment with immune-stimulatory antitumor agents including checkpoint-targeted agents, or docetaxel Interventions N=292 nivolumab (intravenous dose of 3 mg/kg every 2 weeks) N=290 docetaxel (intravenous dose of 75 mg/m every 3 weeks) Primary outcome Overall survival 12.2 months 12.2 https://web.pathway.md/studies/recUMAF4dYxeHInMz 1/2 6/28/23, 12:26 AM CheckMate-057 Pathway 9.4 9.1 months 6.1 months 3.0 months Significant increase 0.0 months Nivolumab Docetaxel Significant increase in overall survival (12.2 months vs. 9.4 months; HR 1.37, 95% CI 1.13 to 1.69) Secondary outcomes No significant difference in median progression free survival (2.3 months vs. 4.2 months; HR 0.92, 95% CI 0.77 to 1.1) Significant increase in objective response (19% vs. 12%; OR 1.7, 95% CI 0.27 to 3.13) Safety outcomes No significant differences in all-causality and any-grade adverse events, but fewer grade 3-4 adverse events were reported with nivolumab than docetaxel. Conclusion In patients with non-squamous non-small cell lung cancer that had progressed during or after platinum-based doublet chemotherapy, nivolumab was superior to docetaxel with respect to overall survival. Reference Borghaei H, Paz-Ares L, Horn L et al. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. Open reference URL https://web.pathway.md/studies/recUMAF4dYxeHInMz 2/2