KEYNOTE‐033: Randomized phase 3 study of pembrolizumab vs docetaxel in previously treated, PD‐L1‐positive, advanced NSCLC

KEYNOTE‐033 (NCT02864394) was a multicountry, open‐label, phase 3 study that compared pembrolizumab vs docetaxel in previously treated, programmed death‐ligand 1 (PD‐L1)‐positive, advanced non‐small cell lung cancer (NSCLC), with most patients enrolled in mainland China. Eligible patients were randomized (1:1) to pembrolizumab 2 mg/kg or docetaxel 75 mg/m2 every 3 weeks. Primary endpoints were overall survival (OS) and progression‐free survival and were evaluated sequentially using stratified log‐rank tests, first in patients with PD‐L1 tumor proportion score (TPS) ≥50% and then in patients with PD‐L1 TPS ≥1% (significance threshold: P