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Background: Gefitinib is an oral agent that inhibits the tyrosine kinase of epidermal growth factor receptor (EGFR), which had antitumor activity in patients with previously treated non-small cell lung cancer (NSCLC). We analyzed the efficacy, toxicitiy, and overall survival time of gefitinib in patients with NSCLC. Patients and Methods: One hundred and twenty-two patients with NSCLC who received gefitinib between 2002 and 2004 in our institutes were evaluated retrospectively. Results: The objective response rate was 24.6%. The variables identified as significant in univariate analysis included gender and smoking habit. The median overall survival time was 14.4 months. Significant variables associated with improved survival included good performance status (PS), female, adenocarcinoma and never smoked status, and never smoked status and good PS were independent prognostic factors in multivariate analysis. Four patients (3.3%) developed interstitial pneumonitis associated with gefitinib. Conclusion: Gefitinib showed favorable anti-tumor activity in females, never smokers and adenocarcinoma.