CONTEXT: Patients with metastatic non-small cell lung cancer are deemed incurable, but they may derive some benefit from systemic palliative chemotherapy. Recently, with the introduction of epidermal growth factor receptor (EGFR) antagonists such as gefitinib (Iressa®), an effective and less toxic option is now available for the treatment of such patients. OBJECTIVE: To assess the activity and toxicity of gefitinib in a group of Brazilian patients. TYPE OF STUDY: Prospective, open label, non-randomized and non-controlled. SETTING: Clínica de Oncologia e Hematologia (CLIOH), São Paulo, Brazil.