Conditions: Non-Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 315
Healthy volunteers: no

Brief summary:
This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib \[Tarceva\] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.

Detailed description:

Arms:
arm 1: Erlotinib 150 mg single daily oral dose until disease progression. arm 2: Erlotinib 300 mg single daily oral dose until disease progression.

Interventions: intervention 1: Erlotinib [Tarceva]
Intervention descriptions: intervention 1: Single daily oral dose

Protocol document: