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

Part of paid clinical trials in Bridgewater, New Jersey.

Sponsor
Sanofi
Study ID
NCT00532155
Phase
PHASE3
Status
Completed

Conditions

  • Carcinoma
  • Non Small Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) — DRUG
    6 mg/kg Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.
  • Placebo — DRUG
    Matching placebo to Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.
  • Docetaxel (Taxotere®) — DRUG
    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.
  • Dexamethasone (pre- and post-medication for docetaxel) — DRUG
    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).

Study Details

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.

Key Dates

Start date
Sep 30, 2007
Status verified
Sep 2025
Primary completion
Jan 31, 2011
Completion
Oct 31, 2011

Study Design

Enrollment
913 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Aflibercept/Docetaxel
    Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
  • Placebo Comparator: Placebo/Docetaxel
    Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Baseline to the date when 687 deaths occurred (26 January 2011) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sanofi-Aventis Administrative OfficeBridgewaterNew Jersey08807-

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Sanofi-Aventis Administrative Office· Bridgewater, NJ

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