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<0.001). At 1 year, the overall 
survival rate was 42% (95% CI, 34 to 50) with nivolumab versus 24% (95% CI, 17 
to 31) with docetaxel. The response rate was 20% with nivolumab versus 9% with 
docetaxel (P=0.008). The median progression-free survival was 3.5 months with 
nivolumab versus 2.8 months with docetaxel (hazard ratio for death or disease 
progression, 0.62; 95% CI, 0.47 to 0.81; P<0.001). The expression of the PD-1 
ligand (PD-L1) was neither prognostic nor predictive of benefit. 
Treatment-related adverse events of grade 3 or 4 were reported in 7% of the 
patients in the nivolumab group as compared with 55% of those in the docetaxel 
group.
CONCLUSIONS: Among patients with advanced, previously treated squamous-cell 
NSCLC, overall survival, response rate, and progression-free survival were 
significantly better with nivolumab than with docetaxel, regardless of PD-L1 
expression level. (Funded by Bristol-Myers Squibb; CheckMate 017 
ClinicalTrials.gov number, NCT01642004.).