The ZD1839 (Iressa, gefitinib) treatment in phase I trials for patients with advanced non-small cell lung cancer (NSCLC) was associated with disease stabilization and tumor regression. The aim of this study was to analyze the efficacy of gefitinib monotherapy as a second- or third-line treatment for locally-advanced and advanced NSCLC. Data for 50 patients were analyzed. Patients were treated at 5 centers in Hungary as part of the gefitinib Expanded Access Programme (EAP). The response rate was 10% (all partial responses), with disease stabilization in 46% of patients. Disease progression was observed in 44% of patients. The median survival according to the Kaplan-Meier method was 8 months. Median survival of patients with adenocarcinoma was significantly increased compared with squamous cell carcinoma and, of the patients responding to therapy, 80% had adenocarcinoma. The 1-year survival rate was 34%. All patients were evaluable for safety; the adverse events seen with gefitinib were generally mild and only two patients had to be withdrawn from the study due to adverse events. The Hungarian experience suggests gefitinib therapy is effective and well tolerated.