FLAURA — Osimertinib Versus Standard EGFR-TKI in First-Line EGFR-Mutated Advanced NSCLC

Phase 3 · 2018 · Non-Small Cell Lung Cancer

Design

Randomized double-blind osimertinib vs standard first-generation EGFR-TKI (gefitinib or erlotinib).

Population

Untreated advanced NSCLC with EGFR exon 19 deletion or L858R mutation.

Primary Endpoint

progression-free survival (PFS)

Key Result

PFS 18.9 vs 10.2 mo (HR 0.46); median OS 38.6 vs 31.8 mo (HR 0.80).

Guideline Impact

NCCN category 1 preferred first-line osimertinib for EGFR-mutant advanced NSCLC