Conditions: Non-Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 424
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Alimta or Taxotere intervention 2: erlotinib [Tarceva]
Intervention descriptions: intervention 1: 500mg/m2 / 3 weeks (Alimta) or 75mg/m2 / 3 weeks (Taxotere) intervention 2: 150mg po daily

Protocol document: