Conditions: Carcinoma, Non-Small-Cell Lung
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 46
Healthy volunteers: no

Brief summary:
CP 751,871 is a fully human monoclonal antibody against the Insulin-Like Growth Factor 1 Receptor (IGF-1R). Preclinical and clinical data indicate that CP 751,871 augments the anti-tumor activity of chemotherapy. This study will identify the Maximal Tolerated Dose of CP 751,871 (or the Maximal Feasible Dose) in combination with standard gemcitabine-cisplatin chemotherapy for the treatment of advanced Non-Small Cell Lung cancer.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: CP-751,871 intervention 2: Cisplatin intervention 3: Gemcitabine intervention 4: Pemetrexed
Intervention descriptions: intervention 1: CP-751,871 at doses ranging from 6 to 20 mg/Kg on Day 1 of each 21-day cycle. CP-751,871 may be administered even after active comparators discontinuation, for a total number of 17 cycles (1 year). intervention 2: Cisplatin 75\* mg/m2 or 80\* mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycles.

\* 75 mg/m2 when in combination with pemetrexed, 80 mg/m2 when in combination with gemcitabine intervention 3: Gemcitabine 1250 mg/m2, IV on Days 1 and 8 of each 21-day cycle up to 6 cycles intervention 4: Pemetrexed 500 mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycle

Protocol document: