IPASS — Gefitinib Versus Carboplatin-Paclitaxel as First-Line Therapy in Selected Asian NSCLC Patients

Phase 3 · 2009 · Non-Small Cell Lung Cancer

Design

Randomized first-line gefitinib vs carboplatin-paclitaxel in clinically selected patients (Asian, adenocarcinoma, never/light smokers).

Population

Advanced NSCLC in East Asian never/light-smoker adenocarcinoma patients.

Primary Endpoint

progression-free survival (PFS)

Key Result

Gefitinib was superior in EGFR-mutation-positive patients but inferior in EGFR wild-type, proving EGFR mutation is the key predictive biomarker.

Guideline Impact

Foundational basis for EGFR mutation testing and first-line EGFR TKI therapy