A randomized phase II study of paclitaxel (P) and carboplatin (C) {+/-} bevacizumab (B) {+/-} dulanermin (D) in non-small cell lung cancer (NSCLC).

7534 Background: D is a pro-apoptotic agonist of death receptors 4 and 5. A randomized, open-label, 5-arm, phase II study evaluated the efficacy and safety of PC ± B ± D in patients (pts) with advanced NSCLC. Methods: Planned sample size = 200 (40/arm). Eligible pts: chemonaive, advanced NSCLC, ECOG PS 0-1. A brain scan was mandatory. Pts received P (200 mg/m2) + C (AUC = 6 mg/mL min). Pts with squamous NSCLC and/or CNS metastases (met) received PC (Arm 1) vs. PC + D (8 mg/kg for 5 days; Arm 2). Pts with non-squamous NSCLC and no CNS met received PC + B (15 mg/kg; Arm 3) vs. PCB + D (8 mg/kg for 5 days; Arm 4) vs. PCB + D (20 mg/kg for 2 days; Arm 5). Pts received PC ± B ± D ≤ 6 cycles Q3W, then continued B and/or D until disease progression. Primary endpoint: objective response rate (ORR; central assessment of complete and partial responses by modified RECIST). Results: 213 pts were randomized (41, 42, 44, 43, 43 to arms 1-5); all were eligible; 41, 39, 42, 40, 41 received ≥ 1 dose of study drug. Median ...