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

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) and Placebo

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 10, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?32 U.S. locations

Locations may change over time.

Who runs it?Sanofi

Study sponsor

Study overview

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)

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Locally advanced→Metastatic or stage IV→

Treatment approach

Chemotherapy→

Study topics

After prior treatment→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

Study sites

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.

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