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

NCT00532155 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 913

Last updated 2025-09-10

Study results available
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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.

Conditions

  • Carcinoma
  • Non Small Cell Lung

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-01-31
Completion
2011-10-31

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00532155 on ClinicalTrials.gov