Conditions: Non-Small-Cell Lung Carcinoma
Keywords: lung cancer advanced non-small cell
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 172
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to evaluate the hypothesis that cixutumumab given in combination with cisplatin and pemetrexed is superior to cisplatin and pemetrexed as first-line therapy for patients with advanced nonsquamous non-small cell lung carcinoma (NSCLC).

Detailed description:

Arms:
arm 1: Induction Treatment: Pemetrexed 500 mg/m\^2 plus cisplatin 75 mg/m\^2 plus cixutumumab 20 mg/kg given intravenously (IV) on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for patients with significant tumor size reduction, after sponsor approval.

Maintenance Therapy: Pemetrexed 500 mg/m\^2 plus cixutumumab 20 mg/kg given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. arm 2: Induction Treatment: Pemetrexed 500 mg/m\^2 plus cisplatin 75 mg/m\^2 given intravenously (IV) on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for patients with significant tumor size reduction, after sponsor approval.

Maintenance Therapy: Pemetrexed 500 mg/m\^2 given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.

Interventions: intervention 1: Pemetrexed intervention 2: Cisplatin intervention 3: Cixutumumab
Intervention descriptions: intervention 1: Administered intravenously (IV) intervention 2: Administered IV intervention 3: Administered IV

Protocol document: