Conditions: Non-Small-Cell Lung Carcinoma Adenocarcinoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 118
Healthy volunteers: no

Brief summary:
To determine if the addition of AG-013736 to chemotherapy is beneficial in patients with advanced lung cancer who have not been previously treated.

Detailed description:

Arms:
arm 1: Bevacizumab will be administered in combination with carboplatin and paclitaxel. arm 2: AG-013736 will be administered in combination with carboplatin and paclitaxel.

Interventions: intervention 1: Bevacizumab intervention 2: Carboplatin intervention 3: Paclitaxel intervention 4: AG-013736 (axitinib) intervention 5: Carboplatin intervention 6: Paclitaxel
Intervention descriptions: intervention 1: Bevacizumab is available as 100 and 400 mg preservative-free, single use vials- The starting dose is 15 mg/kg, iv infusion, every 3 weeks. intervention 2: Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg\*min/ml, iv infusion, every 3 weeks. intervention 3: Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks intervention 4: AG-013736 (axitinib) is available as 1mg, and 5 mg film-coated tablets for oral administration- The starting dose is 5 mg BID- intervention 5: Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg\*min/ml, iv infusion, every 3 weeks. intervention 6: Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks

Protocol document: