A Randomized Phase Ii Study Of Paclitaxel-Carboplatin-Bevacizumab (Pcb) With Or Without Nitroglycerin Patches (Ntg) In Patients (Pts) With Stage Iv Nonsquamous Non-Small Cell Lung Cancer (Nsclc): Nvalt 12 (Nct01171170)

8089 Background: NTG increases tumor blood flow and thereby may augment drug delivery to the tumor and inhibits HIF-1a, a major regulator of hypoxia. In mouse models addition of HIF-1α inhibitors to B significantly impairs tumor growth. A randomized phase II study has shown improved clinical outcome when NTG patches were added to vinorelbine/cisplatin in pts with advanced NSCLC (Yasuda, 2006). We hypothesized that adding NTG to PCB improves progression free survival (PFS), response rate (RR) and overall survival (OS) in pts with stage IV non-squamous NSCLC. Methods: This open-label multicenter phase II trial randomized chemo-naive pts with stage IV non-squamous NSCLC 1:1 to PCB with or without NTG. Main other inclusion criteria: performance score 0-2; measurable disease (RECIST 1.1); adequate bone marrow, liver and renal function; written informed consent; no clinical significant cardiovascular disorders; no significant bleeding. Pts were treated with P 200 mg/m2 day (d) 1-C AUC 6 d1-B 15 mg/kg d1 every 3...