NCT00532155

A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 913 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study included: * A screening visit of up to 21 days prior to randomization * Randomization at baseline (Treatment was initiated with 3 days of randomization) * A treatment period with 3-week treatment cycles until the participant met the following discontinuation criteria: had progressive disease, had unacceptable toxicity, or refused further study treatment * A post study treatment follow-up period (a visit was scheduled every 8 weeks until death or end of study)

Conditions

• Carcinoma
• Non Small Cell Lung

Interventions

Type	Name	Description
DRUG	Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)	6 mg/kg Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.
DRUG	Placebo	Matching placebo to Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.
DRUG	Docetaxel (Taxotere®)	75 mg/m² docetaxel in 250 mL dextrose 5% or NaCl 0.9% administered intravenously (IV) over 1 hour, on Day 1 every 3 weeks.
DRUG	Dexamethasone (pre- and post-medication for docetaxel)	As a pre- and post-medication for docetaxel, 8 mg dexamethasone was administered orally, the evening before Day 1, on Day 1 (early morning, 1 hour before docetaxel treatment, and evening) and on Day 2 (morning and evening).

Timeline

• Start date: 2007-09-01
• Primary completion: 2011-01-01
• Completion: 2011-10-01
• First posted: 2007-09-20
• Last updated: 2025-09-10
• Results posted: 2013-01-01

Locations

32 sites across 32 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, Turkey (Türkiye), United Kingdom