A phase II, multicenter evaluation of docetaxel, gemcitabine, and bevacizumab followed by bevacizumab alone in patients with locally advanced or metastatic non-small cell lung cancer (central localization excluded)

19077 Background: Platinum-based doublets are the standard of care for advanced and metastatic NSCLC; however many patients (pts) can not tolerate side effects of this combination. This study was designed to evaluate the efficacy and tolerability of Docetaxel + Gemcitabine in combination with Bevacizumab (D/G/B) in chemotherapy-naive Stage IIIB(non-pleural effusion)/IV NSCLC pts. Methods: Newly diagnosed pts (> 18y) with histologically proven NSCLC (squamous cell excluded) and ECOG PS ≤ 2 were assigned to receive D/G/B: G -1000 mg/m2 IV over 0.5 hour on Days 1 and 8; D -75 mg/m2 IV over 1 hour on Day 8; and B -15 mg/kg IV on Day 1 over 21 day cycles, for 6 cycles maximum. Response was evaluated after every 2 treatment cycles (i.e. after Cycles 2, 4, and 6). Subjects with responding and stable disease (i.e., SD, PR, or CR) received bevacizumab 15 mg/kg IV every 21 days after completion of chemotherapy to complete 1 year of treatment, or until discontinuation. The primary endpoint for this study was PFS. Se...