FLAURA2 — Osimertinib With or Without Chemotherapy as First-Line Treatment in EGFR-Mutated Advanced NSCLC (FLAURA2)

Phase 3 · 2023 · Non-Small Cell Lung Cancer

Design

Randomized open-label trial of osimertinib plus platinum-pemetrexed chemotherapy versus osimertinib monotherapy.

Population

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

Primary Endpoint

progression-free survival (PFS)

Key Result

PFS 25.5 vs 16.7 months (HR 0.62) favoring the chemotherapy combination, at the cost of more hematologic toxicity.

Guideline Impact

NCCN-listed osimertinib plus platinum-pemetrexed as a first-line option for EGFR-mutant advanced NSCLC