Randomized phase II trial of a tumor vascular disrupting agent fosbretabulin tromethamine (CA4P) with carboplatin (C), paclitaxel (P), and bevacizumab (B) in stage IIIb/IV nonsquamous non-small cell lung cancer (NSCLC): The FALCON trial.

7587 Background: CA4P is a small-molecule tumor vascular disrupting agent (VDA) that has shown additive effects in combination with chemotherapy and antiangiogenic therapy. This phase II study evaluated CA4P in combination with C (carboplatin) + P (paclitaxel) + B (bevacizumab) in NSCLC. Methods: This is an open-label, randomized controlled study for patients with untreated, histologically confirmed stage IIIb or IV nonsquamous NSCLC. 50 out of a planned 60 patients were randomized to receive up to 6 cycles of C + P + B with (CA4P arm) or without CA4P (control arm). After 6 cycles of therapy, patients without progression continued to receive their randomized treatment B or B + CA4P until progression. Enrollment will be completed Q1 2010. The primary endpoint is progression-free survival (PFS). Secondary endpoints include response rates and overall survival. Results: As of January, 2010, 46 patients received treatment, 23 in each arm. Preliminary results from 46 evaluable patients showed a median PFS of 5....