At a glance
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A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment With Pemetrexed + Cisplatin for Advanced Non-squamous Non-Small Cell Lung Cancer.
In Brief
A Phase 3 clinical trial evaluating Pemetrexed, Cisplatin, and 2 other interventions for Non-Small Cell Lung Cancer. Completed, enrolled 939 participants across 68 sites in 15 countries.
Detailed Summary
This study will compare progression-free survival in patients with advanced non-squamous non-small cell lung cancer. Patients who do not progress following 4 cycles of induction treatment with pemetrexed and cisplatin will be randomized 2:1 to receive either maintenance pemetrexed or placebo.
Study Details
Timeline
Interventions
Induction therapy: 500 mg/m\^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles
Induction therapy: Cisplatin: 75 mg/m\^2, IV, on Day 1 of each 21-day cycle for 4 cycles
Maintenance therapy: Normal saline (0.9% sodium chloride) administered IV on Day 1 every 21-day cycle until progressive disease or treatment discontinuation
Maintenance therapy: 500 mg/m\^2, IV, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation.
Best Supportive Care is treatment given with the intent to maximize quality of life. Best Supportive Care excludes any treatment in which the goal is to cure or slow the progression of the study disease. Patients will receive Best Supportive Care as judged by their treating physician. Those therapies considered acceptable include, but are not limited to, palliative radiation to extrathoracic structures, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral).