At a glance
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A Randomized Phase 2 Study Comparing Pemetrexed Plus Best Supportive Care With Best Supportive Care as Maintenance, Following First-Line Treatment With Pemetrexed-Cisplatin, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
In Brief
A Phase 2 clinical trial evaluating pemetrexed and Best Supportive Care for Non Small Cell Lung Cancer. Completed, enrolled 106 participants across 5 sites in 3 countries.
Detailed 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).
Study Details
Timeline
Interventions
500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles
Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.