A randomized phase II trial of a vascular disrupting agent (VDA) fosbretabulin tromethamine (CA4P) with carboplatin (C), paclitaxel (P), and bevacizumab (B) in stage 3B/4 nonsquamous non-small cell lung cancer (NSCLC): Analysis of safety and activity of the FALCON trial.

7559 Background: Inhibition of angiogenesis has clinical benefits in NSCLC. Depriving tumors of blood flow by adding bevacizumab (B) to other vasculature-directed agents has been hampered by toxicity. CA4P has shown additive effects with chemotherapy and antiangiogenic therapy. This phase II study evaluated the safety and activity of CA4P + carboplatin (C) + paclitaxel (P) + B in NSCLC. Methods: This is a randomized, open-label study in patients with untreated, Stage 3B/4 non-squamous NSCLC. 63 patients were randomized to receive up to 6 cycles of C + P + B with CA4P (CA4P Arm) or without CA4P (Control Arm). After 6 cycles of therapy, patients without progression continued to receive their randomized treatment (CA4P + B or B) until progression. Enrollment completed in June 2010. Results: 60 patients were treated (31 on the CA4P Arm and 29 on the Control Arm). This interim analysis (data cut-off 13Jan2011) has a median follow up 9.7 months. Responses were more frequent in the CA4P Arm, with partial respons...