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

Joachim von Pawel, Vera Gorbounova, Martin Reck, Dariusz M. Kowalski, Aurore Allard, Mustapha Chadjaa, Augustin Rey, Jaafar Bennouna, Francesco Grossi

Research output: Contribution to journalArticle

Abstract

Background: DISRUPT 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). Methods: Patients were randomised to ombrabulin 35mg/m2 or placebo followed by a taxane-platinum regimen every 3 weeks. Results: Overall, 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. Conclusion: This 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.

Original languageEnglish
Pages (from-to)224-229
Number of pages6
JournalLung Cancer
Volume85
Issue number2
DOIs
Publication statusPublished - 2014

Keywords

  • Non-small cell lung cancer (NSCLC)
  • Ombrabulin
  • Phase 2
  • Platinum
  • Taxane

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research
  • Medicine(all)

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