ALEX — Alectinib Versus Crizotinib in Treatment-Naive ALK-Positive Advanced NSCLC

Phase 3 · 2017 · Non-Small Cell Lung Cancer

Design

Randomized open-label alectinib vs crizotinib in treatment-naive ALK-positive disease.

Population

Untreated advanced ALK-positive NSCLC.

Primary Endpoint

investigator-assessed progression-free survival (PFS)

Key Result

Median PFS 34.8 vs 10.9 mo (HR 0.43); 12-mo CNS progression 9.4% vs 41.4%.

Guideline Impact

NCCN category 1 first-line alectinib for ALK-positive advanced NSCLC