Phase III, randomized, open‐label, first‐line study in Asia of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non‐small‐cell lung cancer …

Aim:  In the IRESSA Pan‐Asia Study (IPASS), 1217 patients in East Asia with pulmonary adenocarcinoma who were never‐smokers or ex/light‐smokers received first‐line gefitinib (250 mg/day) or carboplatin/paclitaxel (area under the curve 5/6; 200 mg/m2). Efficacy analyses were pre‐planned in patients in China. Methods:  In China, 372 patients (30.6% of the overall group) were randomized. The primary end‐point was progression‐free survival (PFS). Secondary end‐points were overall survival (OS), objective response rate (ORR), health‐related quality of life (HRQoL), symptom improvement, safety and tolerability. Results:  For patients in China, PFS did not significantly differ from the overall IPASS population (interaction test P= 0.427). PFS was numerically longer (hazard ratio [HR] 0.79; 95% CI 0.62–1.01; P= 0.065; median PFS 6.8 months for both treatments) and ORR significantly higher (ORR 44.6 vs 29 …