Conditions: Non-Squamous Non-Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 451
Healthy volunteers: no

Brief summary:
This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva or placebo, plus platinum-based therapy, as first line treatment in patients with advanced or recurrent non-small cell lung cancer. Patients will be randomized to receive gemcitabine (1250mg/m2 iv) on days 1 and 8, and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by Tarceva 150mg/day or placebo from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by Tarceva or placebo monotherapy.The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Placebo intervention 2: Platinum chemotherapy (cisplatin or carboplatin) intervention 3: erlotinib [Tarceva] intervention 4: gemcitabine
Intervention descriptions: intervention 1: po on days 15-28 of each 4 week cycle until disease progression intervention 2: cisplatin --75mg/m2 oon day 1 of each 4 week cycle for 6 cycles or carboplatin--5xAUC on day 1 of each 4 week cycle for 6 cycles intervention 3: 150mg po on days 15-28 of each 4 week cycle until disease progression intervention 4: 1250mg/m2 iv on days 1 and 8 of each 4 week cycle for 6 cycles

Protocol document: