Conditions: Squamous Non Small Cell Lung Cancer
Keywords: NSCLC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 167
Healthy volunteers: no

Brief summary:
The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy of paclitaxel and carboplatin is more effective to treat cancer than the standard chemotherapy of paclitaxel and carboplatin alone.

Detailed description:

Arms:
arm 1: Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.

Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.

Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.

The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles. Necitumumab may continue until Progressive Disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent. arm 2: Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. After completion of chemotherapy, participants will be followed until radiographic documentation of PD.

Interventions: intervention 1: Necitumumab intervention 2: Paclitaxel intervention 3: Carboplatin
Intervention descriptions: intervention 1: Administered IV intervention 2: Administered IV intervention 3: Administered IV

Protocol document: