Conditions: Carcinoma, Large Cell Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Carcinoma, Adenosquamous Cell
Keywords: IGR-1R Non small cell lung cancer CP-751 871 Figitumumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 583
Healthy volunteers: no

Brief summary:
The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).

Detailed description:
This study was terminated on March 8, 2010 due to an analysis by an independent Data Safety Monitoring Committee (DSMC) indicating that the addition of CP-751,871 \[figitumumab\] to erlotinib \[Tarceva\] would be unlikely to meet the primary endpoint of improving overall survival when compared to erlotinib alone.

This Oncology study continues as terminated, however for ethical reasons some patients, noted with resultant benefit, continue receiving treatment.

Arms:
arm 1: The CP 751,871 treatment in combination with erlotinib will be given in three week cycles.

CP 751,871 (20 mg/kg) + erlotinib (150 mg/day) CP 751,871 will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter. arm 2: Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food)

Interventions: intervention 1: CP 751,871 (Figitumumab) intervention 2: Erlotinib intervention 3: Erlotinib
Intervention descriptions: intervention 1: CP 751,871 (20 mg/kg) will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter. intervention 2: Erlotinib (one tablet of 150 mg/day PO). intervention 3: Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food.

Protocol document: