Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: NSCLC Erlotinib Tarceva Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 143
Healthy volunteers: no

Brief summary:
This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.

Detailed description:

Arms:
arm 1: 150 mg erlotinib daily arm 2: carboplatin AUC 6 on Day 1 to 21 days, paclitaxel 200 mg/m2 on Day 1 to 21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity

Interventions: intervention 1: Tarceva intervention 2: carboplatin intervention 3: paclitaxel
Intervention descriptions: intervention 1: oral tablet intervention 2: IV intervention 3: IV

Protocol document: