DISRUPT: A randomized phase 2 trial of ombrabulin (AVE8062) combined with a taxane-platinum regimen in the first-line treatment of metastatic non-small cell lung cancer (NSCLC)

Introduction: Ombrabulin is a vascular disrupting agent and analogue of combretastatin A4 that damages established tumor vasculature, which causes tumor necrosis and regression. DISRUPT (NCT01263886) evaluated whether adding ombrabulin to a taxane-platinum doublet in the 1st-line setting improves outcomes in patients with metastatic NSCLC. Methods: Patients (≥18yrs, ECOG 0 – 1, stage IV) were randomized 1:1 to ombrabulin 35 mg/m2 or placebo (Pbo) on D1 followed by a taxane-platinum regimen on D2 (docetaxel 75 mg/m2 + cisplatin 75 mg/m2 or paclitaxel 200 mg/m2 + carboplatin AUC 6), q3wk. Randomization was stratif…