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 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.
Checked against the public recordLast updated Sep 10, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Sanofi
- Interventions being studied
- Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®); Drug: Placebo; Drug: Docetaxel (Taxotere®); Drug: Dexamethasone (pre- and post-medication for docetaxel)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Histological/cytological proven locally advanced or metastatic non-small cell lung cancer * Disease progression during or after one, and only one, prior anticancer therapy which is platinum-based for advanced or metastatic disease * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * Adequate renal, liver and bone marrow functions Exclusion Criteria: * Squamous histology/cytology * Less than 28 days elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization * Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to \> 25% of bone marrow * Prior docetaxel treatment * Uncontrolled hypertension The above information was not intended to contain all considerations relevant to participation in a clinical trial.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Sanofi-Aventis Administrative OfficeBridgewater, New Jersey
- Sanofi-Aventis Administrative OfficeBuenos Aires
- sanofi-aventis Australia & New Zealand administrative officeMacquarie Park, New South Wales
- Sanofi-Aventis Administrative OfficeVienna
- Sanofi-Aventis Administrative OfficeSão Paulo
- Sanofi-Aventis Administrative OfficeSofia
- Sanofi-Aventis Administrative OfficeLaval
- Sanofi-Aventis Administrative OfficeSantiago
- Sanofi-Aventis Administrative OfficeShanghai
- Sanofi-Aventis Administrative OfficePrague
- Sanofi-Aventis Administrative OfficeTallinn
- Sanofi-Aventis Administrative OfficeHelsinki
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 10, 2025. Always confirm current availability with the study team.