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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Aflibercept; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Docetaxel

Criteria

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.