Randomized, phase II trial of NGR-hTNF and chemotherapy in chemotherapy-naive patients with non-small cell lung cancer (NSCLC): Preliminary results.

7568 Background: NGR-hTNF is a highly selective vascular targeting agent, that binds CD13 overexpressed on tumor blood vessels, obtained by adding the NGR peptide to the human tumor necrosis factor (hTNF). By damaging tumor vasculature and decreasing interstitial pressure, NGR-hTNF improves penetration of cytotoxic agents within the tumor. Methods: Chemo-naive, stage IIIb-IV NSCLC patients (pts), stratified by histology (nonsquamous v squamous) and PS (0 v 1), were randomly assigned to receive either chemotherapy (CT) plus NGR-hTNF 0.8 μg/m2 day 1 (arm A) or CT alone (arm B). Brain lesions were included. Study regimens for both arms consisted of cisplatin 80 mg/m2 day 1 plus either gemcitabine 1,250 mg/m2 days 1,8 for squamous or pemetrexed 500 mg/m2 day 1 for nonsquamous histology, every 3 weeks up to 6 cycles. In arm A, NGR-hTNF was administered until progression (PD). Primary endpoint was progression-free survival (PFS). Assuming 15% increase in PFS rate (β=20% and α=20%), a sample size of 102 pts was ...