Conditions: Advanced Non-Small Cell Lung Cancer
Keywords: Advanced Non-Small Cell Lung Cancer of Nonsquamous Histology Advanced Lung Cancer Non-Small Cell Lung Cancer Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 361
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the regimens of pemetrexed, carboplatin with pemetrexed maintenance and paclitaxel, carboplatin, bevacizumab with bevacizumab maintenance in participants with Stage IV nonsquamous non-small cell lung cancer.

Detailed description:
This is a multicenter, randomized, open-label, Phase III trial. Eligible participants will be randomized in a 1:1 ratio to receive pemetrexed and carboplatin followed by pemetrexed or paclitaxel, carboplatin, and bevacizumab followed by bevacizumab as their study treatment. Participants randomized to Pemetrexed + Carboplatin + Pemetrexed will receive folic acid, vitamin B12, and dexamethasone as stated in the pemetrexed label. Before administration of paclitaxel, participants randomized to Paclitaxel + Carboplatin + Bevacizumab will receive premedication (dexamethasone, diphenhydramine, and cimetidine or ranitidine) as recommended in the paclitaxel label.

Arms:
arm 1: Pemetrexed and Carboplatin followed by Pemetrexed arm 2: Paclitaxel, Carboplatin, and Bevacizumab followed by Bevacizumab

Interventions: intervention 1: Pemetrexed intervention 2: Carboplatin intervention 3: Paclitaxel intervention 4: Bevacizumab
Intervention descriptions: intervention 1: Induction therapy: 500 milligrams/square meter (mg/m²) given intravenously every 21 days for 4 cycles. Maintenance therapy: 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation. intervention 2: Induction Therapy (every 21 days for 4 cycles): Area Under the Curve (AUC) 6 \[maximum possible dose of 900 milligrams (mg)\] intravenously infused over 30 minutes. intervention 3: Induction Therapy (every 21 days for 4 cycles): 200 mg/m² intravenously infused over 3 hours intervention 4: Induction therapy: 15 milligrams/kilogram (mg/kg) given intravenously every 21 days for 4 cycles. Maintenance therapy: 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.

Protocol document: