Randomized Gefitinib Trial

Patients with locally advanced (IIIB with effusion) or metastatic non-small cell lung cancer (NSCLC), EGFR FISH positive, candidate for a first-line platinum-based chemotherapy will be considered eligible for the trial. After evaluation of inclusion and exclusion criteria, and after signature of informed consent form, all eligible patients will be randomized to receive standard chemotherapy (control arm) or gefitinib (250 mg daily dose-experimental arm). Before, and in every case, no more than 4 weeks before study entry, all eligible patients will receive a complete disease staging, including thoracic and abdominal CT-scan, and blood sampling. Bronchoscopy will be done if not previously performed. Bone scan and brain CT-scan will be performed only if clinically indicated. Disease assessment will be performed every 6 weeks (every 2 cycles) for the first 6 cycles, and thereafter every 3 months, with a confirmatory evaluation in all patients with response or disease stabilization no less than 4 weeks after the response assessment, according to RECIST Criteria. A complete disease staging, including the above mentioned procedures, will be performed in case of progressive disease, and, in every cases, when patient withdrawals the trial. Following completion of protocol therapy, patients will be followed every 3 months.