Randomized phase II trial of erlotinib (E) alone or in combination with carboplatin/paclitaxel (CP) in never or light former smokers with advanced lung adenocarcinoma: CALGB 30406.

7503 Background: EGFR kinase inhibitors are effective in never-smokers with NSCLC especially in those harboring EGFR mutations. In a prior phase III study (TRIBUTE) ECP was associated with improved RR, PFS, and OS compared to CP but only in never-smokers. CALGB 30406 prospectively evaluated E and ECP in never/light former smokers with chemotherapy-naive advanced lung adenoca and evaluated the impact of EGFR mutations on outcome. Methods: Chemotherapy-naive, never, or light former (≤ 10 pack years, > 1 yr since cessation) smokers, with advanced lung adenoca were randomized to E alone (150 mg/day) or ECP (E 150 mg/day given continuously; C [AUC = 6] and P (200 mg/m2) both q21 days) for 6 cycles followed by E. Primary endpoint was PFS in both arms. Collection of pretreatment tumor for assessment of EGFR mutations was mandatory. Results: Between 8/05 and 4/09 188 pts were accrued; 182 pts randomized (E=82; ECp=100) and treated. Baseline characteristics (E/ECP) were well balanced: Female: 61%/58%; Caucasian: 7...