DISRUPT: A randomised phase 2 trial of ombrabulin (AVE8062) plus a taxane–platinum regimen as first-line therapy for metastatic non-small cell lung cancer

Abstract

BackgroundDISRUPT evaluated whether adding the vascular-disrupting agent ombrabulin to a taxane–platinum doublet in the first-line setting improved progression-free survival (PFS) in patients with metastatic non-small cell lung cancer (NSCLC). MethodsPatients were randomised to ombrabulin 35mg/m2 or placebo followed by a taxane–platinum regimen every 3 weeks. ResultsOverall, 176 patients were randomised. After 124 events, median PFS was not significantly improved with ombrabulin vs placebo (5.65 vs 5.45 months; HR 0.948; 60% CI 0.813–1.106; one-sided P=0.39). The two groups showed similar overall survival (median 11.0 months in both groups), objective response rate (32% ombrabulin; 31% placebo) and safety profiles. ConclusionThis study did not meet its primary endpoint of improving PFS by adding ombrabulin to a taxane–platinum regimen for first-line treatment of metastatic NSCLC.