Phase 3 trial of pembrolizumab versus placebo after surgery for Stage IB-IIIA NSCLC posts results

This Phase 3 randomized controlled trial enrolled 1177 participants with Stage IB, II, or IIIA non-small cell lung cancer (NSCLC) who had undergone surgical resection (lobectomy or pneumonectomy), with or without prior adjuvant chemotherapy. Participants were randomized to receive pembrolizumab or placebo. The primary endpoints were Disease-Free Survival (DFS) and DFS specifically in participants with a PD-L1 Tumor Proportion Score (TPS) of 50% or greater. The median follow-up was 86.6 months. The source posting these results does not provide the specific numerical outcomes for these endpoints, including hazard ratios, absolute event numbers, or statistical significance. No data on adverse events, serious adverse events, discontinuations, or tolerability are reported. A key limitation is the absence of reported efficacy and safety data in the available source, which precludes any assessment of benefit or risk. The study was sponsored by Merck Sharp & Dohme LLC, the manufacturer of pembrolizumab. The practice relevance cannot be determined until the complete trial results, including detailed efficacy and safety analyses, are published in a peer-reviewed format.