Conditions: Non Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 598
Healthy volunteers: no

Brief summary:
This study will compare the overall survival of participants with locally-advanced, Stage III Non-Small Cell Lung Cancer (NSCLC) with nonsquamous cell histology.

Detailed description:

Arms:
arm 1: Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (TRT) ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles

Concurrent Phase:

Pemetrexed: 500 milligrams per meter squared (mg/m\^2), intravenous (IV) on Day 1 of each 21-day cycle for 3 cycles.

Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gray \[Gy\] per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.

Consolidation Phase:

Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles arm 2: Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles

Concurrent Phase:

Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36

Consolidation Phase options:

Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22

Interventions: intervention 1: Pemetrexed intervention 2: Cisplatin intervention 3: Etoposide intervention 4: Vinorelbine intervention 5: Paclitaxel intervention 6: Carboplatin intervention 7: Thoracic Radiation Therapy (TRT)
Intervention descriptions: intervention 1: infusion over 10 minutes intervention 2: infusion over 60 minutes with adequate anti-emetic treatment and appropriate hydration per local practice guidelines intervention 3: administered per local practice guidelines over a minimum of 30 minutes intervention 4: administered over 6-10 minutes infusion per local practice guidelines intervention 5: administered as a 3-hour infusion intervention 6: administered per local practice guidelines over 30 minutes intervention 7: None

Protocol document: