Conditions: Non Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 106
Healthy volunteers: no

Brief summary:
This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer.

A total of approximately 100 patients are planned to be enrolled, and following completion of four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive care alone).

Detailed description:

Arms:
arm 1: Pemetrexed: 500 milligrams per square meter (mg/m²) , intravenous (IV), Day 1 of each 21-day cycle for 6 cycles

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. arm 2: Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Interventions: intervention 1: pemetrexed intervention 2: Best Supportive Care
Intervention descriptions: intervention 1: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles intervention 2: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Protocol document: