Conditions: Non-Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 154
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4 week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The anticipated time on study treatment is until disease progression or unacceptable toxicity.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: erlotinib [Tarceva] intervention 2: placebo intervention 3: gemcitabine intervention 4: cisplatin intervention 5: carboplatin
Intervention descriptions: intervention 1: 150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily intervention 2: orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application intervention 3: 1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles intervention 4: 75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin intervention 5: 5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin

Protocol document: