A randomized phase III trial of gemcitabine (G) in combination with carboplatin (C) or paclitaxel (P) versus paclitaxel plus carboplatin in advanced (Stage IIIB, IV) non-small cell lung cancer (NSCLC): Update of the Alpha Oncology trial (A1-99002L)

LBA7025 Background: Two-drug regimens are the ‘standard of care‘ for treatment of advanced NSCLC. The role of non-platinum containing doublets continues to evolve. Gemcitabine and paclitaxel, a non-platinum-containing doublet needs to be prospectively compared to standard doublets. We are conducting a multicenter, randomized trial designed to compare the efficacy of gemcitabine-containing platinum and non-platinum doublet regimens with the most commonly used regimen of P+C to identify the combination associated with the best therapeutic index. We are now able to provide an update to the preliminary analysis of this ongoing trial previously reported. Methods: Between July 2000 and Nov 2004, 929 chemonaive patients (pts) with advanced stage (IIIB/IV) NSCLC, and ECOG PS < 2 were randomized to: (GC) G 1,000 mg/m2 IV on days 1, 8 plus C AUC 5.5, day 1 vs. (GP) G 1,000 mg/m2 IV on days 1,8 plus paclitaxel 200 mg/m2, day 1 vs. the control arm (PC) paclitaxel 225 mg/m2 plus carboplatin AUC 6.0, day 1. All three r...