CheckMate 017 & 057 — Nivolumab Versus Docetaxel in Previously Treated Advanced Squamous (017) and Nonsquamous (057) Non-Small Cell Lung Cancer

Phase 3 · 2015 · Non-Small Cell Lung Cancer

Design

Two parallel randomized trials of nivolumab monotherapy vs docetaxel after platinum-based chemotherapy — CheckMate 017 (squamous, NCT01642004) and CheckMate 057 (nonsquamous, NCT01673867).

Population

Advanced NSCLC that progressed after platinum-based chemotherapy; squamous (017) and nonsquamous (057).

Primary Endpoint

overall survival (OS)

Key Result

Squamous (017): OS 9.2 vs 6.0 mo (HR 0.59). Nonsquamous (057): OS 12.2 vs 9.4 mo (HR 0.73). Durable long-term survivors in both.

Guideline Impact

Basis for nivolumab's approval in previously treated metastatic NSCLC