At a glance
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A Randomized Ph 3 Study Comparing First-Line Pemetrexed/Cisplatin Followed by Gefitinib With Gefitinib Alone in East Asian Never Smoker or Light Ex-Smoker Patients With Locally Advanced or Metastatic Nonsquamous NSCLC
In Brief
A Phase 3 clinical trial evaluating Pemetrexed, Cisplatin, and 1 other intervention for Non Small Cell Lung Cancer. Completed, enrolled 236 participants across 12 sites in 5 countries.
Detailed Summary
The purpose of this study is to compare two different approaches to treating non-small cell lung cancer (NSCLC) in East Asian never-smoker participants. Half of the participants will receive chemotherapy (pemetrexed/cisplatin) followed by an oral anti-cancer agent (gefitinib) and the other half of the participants will receive only the oral anti-cancer agent (gefitinib).
Study Details
Timeline
Interventions
500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles.
75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
250 milligrams (mg) administered orally once a day, every day of 21-day cycle, for maintenance in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy
250 milligrams (mg) administered orally once a day, every day of 21-day cycles administered as a monotherapy