A Multinational, Randomized, Double-Blind Study Comparing Aflibercept Versus Placebo in Patients Treated With Second-Line Docetaxel After Failure of One Platinum Based Therapy for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (VITAL)

NCT00532155 Phase 3 COMPLETED Results posted

The primary objective of the study was to demonstrate overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC). The secondary objectives were to compare other efficacy parameters, to assess the overall safety of the two treatment arms, to assess the pharmacokinetics of intravenous (IV) aflibercept in this participant population and to determine immunogenicity of IV aflibercept in all participants.

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	913
Start date	2007-09
Completion	2011-10

Conditions

• Carcinoma
• Non Small Cell Lung

Interventions

• Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
• Placebo
• Docetaxel (Taxotere®)
• Dexamethasone (pre- and post-medication for docetaxel)

Primary outcomes

• Overall Survival (OS) — Baseline to the date when 687 deaths occurred (26 January 2011)
  OS was time interval from the date of randomization to the date of death due to any cause. If death was not observed during the study, overall survival time was censored at the last date the participant was known to be alive, or the study cutoff date, whichever was earlier. The cut-off date for the OS was date when 687 deaths were observed. OS was estimated from Kaplan-Meier Curves.

Countries

United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Czechia, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Malaysia, Netherlands, Poland, Portugal, Romania, Russia, Singapore, South Korea, Spain, Sweden, Taiwan