Conditions: Non-Small-Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 120
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to determine the 2-year survival rate of both of the chemotherapy regimens in patients with inoperable non-small-cell lung cancer.

Detailed description:

Arms:
arm 1: Pemetrexed + Carboplatin arm 2: Pemetrexed + Cisplatin

Interventions: intervention 1: pemetrexed intervention 2: cisplatin intervention 3: carboplatin intervention 4: radiation therapy
Intervention descriptions: intervention 1: Phase 1 - 500 milligram/meter squared (mg/m²), administered intravenously, every 21 days for 3 cycles

Phase 2 - 500 mg/m², administered intravenously, every 21 days for 3 cycles

Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation therapy for each phase intervention 2: Phase 1 - 30 mg/m² and 75 mg/m², administered intravenously, Days 1, 8, 22, 29 and 43

Phase 2 - 75 mg/m², administered intravenously, every 21 days for 3 cycles intervention 3: Phase 1 - dosed at area under the curve (AUC) 2 milligram/milliliter\*minute (mg/mL\*min), administered intravenously, Days 1, 8, 22, 29 and 43

Phase 2 - dosed at AUC 5 mg/mL\*min, administered intravenously, every 21 days for 3 cycles intervention 4: Phase 1 - 2 Gray, daily, 5 days a week for Days 1-51

Phase 2 - 2 Gray, daily, 5 days a week for Days 1-45

Protocol document: