Conditions: Non-Squamous Non-Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 74
Healthy volunteers: no

Brief summary:
This randomized parallel group study will assess the efficacy and safety of erlotinib \[Tarceva\], as monotherapy or intermittent dosing with docetaxel, in second-line setting in former-smoker male patients with advanced or metastatic squamous non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg/day orally) as monotherapy or 4 cycles of docetaxel (75 mg/m2 intravenously every 3 weeks) plus Tarceva (150 mg/day orally, days 2-16 each cycle) followed by Tarceva monotherapy. Anticipated time on study treatment is until disease progression.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: docetaxel intervention 2: erlotinib [Tarceva] intervention 3: erlotinib [Tarceva]
Intervention descriptions: intervention 1: 75 mg/m2 intravenously every 3 weeks for 4 cycles intervention 2: 150 mg/day orally, days 2-16 each 3-week cycle for 4 cycles; 150 mg/day orally thereafter intervention 3: 150 mg/day orally as monotherapy

Protocol document: