Conditions: Non-Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 889
Healthy volunteers: no

Brief summary:
This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The anticipated time on study treatment is until disease progression; the target sample size is 500+ individuals.

Detailed description:

Arms:
arm 1: Participants received erlotinib, 150 milligrams (mg), orally (PO), daily from randomization until progressive disease (PD), death, or unacceptable toxicity. arm 2: Participants received a placebo, PO, daily, from randomization until PD, death, or unacceptable toxicity.

Interventions: intervention 1: erlotinib [Tarceva] intervention 2: Placebo
Intervention descriptions: intervention 1: 150mg po daily intervention 2: po daily

Protocol document: