Conditions: Carcinoma Non Small Cell Lung
Keywords: lung cancer angiogenesis inhibitor chemotherapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 913
Healthy volunteers: no

Brief 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.

Detailed description:
The study included:

* A screening visit of up to 21 days prior to randomization
* Randomization at baseline (Treatment was initiated with 3 days of randomization)
* A treatment period with 3-week treatment cycles until the participant met the following discontinuation criteria: had progressive disease, had unacceptable toxicity, or refused further study treatment
* A post study treatment follow-up period (a visit was scheduled every 8 weeks until death or end of study)

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) intervention 2: Placebo intervention 3: Docetaxel (Taxotere®) intervention 4: Dexamethasone (pre- and post-medication for docetaxel)
Intervention descriptions: intervention 1: 6 mg/kg Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks. intervention 2: Matching placebo to Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks. intervention 3: 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. intervention 4: 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).

Protocol document: