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NCT00532155 · ClinicalTrials.gov registry record · Phase 3
A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 913
- Enrollment target
NCT00532155: Completed Phase 3 study, sponsored by Sanofi.
NCT00532155 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 913 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00532155, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 913 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
- DRUG Docetaxel (Taxotere®)
- DRUG Dexamethasone (pre- and post-medication for docetaxel)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 913 participants |
| Start Date | 2007-09 |
| Est. Completion | 2011-10 |
| Phase | Phase 3 |
What the finished NCT00532155 record still lists
NCT00532155 is an interventional study that assigns participants to a tested intervention. The registered 913 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00532155 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00532155 about?
NCT00532155 is a clinical study titled "A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer". 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 o...
What is the current status of trial NCT00532155?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 913 participants. The study started on 2007-09. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00532155?
The interventions under investigation include: Placebo (DRUG), Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) (DRUG), Docetaxel (Taxotere®) (DRUG), Dexamethasone (pre- and post-medication for docetaxel) (DRUG).
Who is sponsoring clinical trial NCT00532155?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00532155's enrollment target sits among peer trials
913 347th of 2000 higher than 1,654 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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