At a glance
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An Open-label, Randomized Study to Evaluate the Effect of Tarceva, Compared With Alimta (Pemetrexed) or Taxotere (Docetaxel),on Survival in Patients With Advanced, Recurrent or Metastatic Non-small Cell Lung Cancer Who Have Experienced Disease Progression During Platinum-based Chemotherapy
In Brief
A Phase 3 clinical trial evaluating Alimta or Taxotere and erlotinib [Tarceva] for Non-Small Cell Lung Cancer. Completed, enrolled 424 participants across 123 sites in 27 countries.
Detailed Summary
This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals.
Study Details
Timeline
Interventions
500mg/m2 / 3 weeks (Alimta) or 75mg/m2 / 3 weeks (Taxotere)
150mg po daily