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
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)
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Overall Survival (OS)
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.
Baseline to the date when 687 deaths occurred (26 January 2011)
No
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
EFC10261
NCT00532155
September 2007
October 2011
Name | Location |
---|---|
Sanofi-Aventis Administrative Office | Bridgewater, New Jersey 08807 |