Abstract: Objective 　Analyze const rastively the clinical efficacy and toxicity of GP ( Gemcitabine + Cispla2 tin) regimen and single agent Gefitinib in f rist line t reatment of ⅢB～ Ⅳstage non2small cell lung cancer (NSCLC) . Methods 　Sixty cases with stage ⅢB～ ⅣNSCLC pathologically proved were enrolled in this study. Oral Gefitinib 250mg daily were given to twenty2six cases ; the other thirty2four cases were t reated with Gemcitabine ( GEM, 1250 mg/ m2 ) on d 1 and d 8 and Cisplatin (DDP, 75 mg/ m2 ) on d1. Every three weeks (21days) as a cycle. The efficacy and adverse effect s were evaluated af ter two cycles of t reatment . Results 　The overall response rate (ORR) of single agent Gefitinib group was 26. 9 %(7/ 26), and that of combined GP group was 29. 4 %(10/ 34) ; there is no statistically significant difference ( P > 0. 05) . The clinical disease cont rol rate of Gefitinib group was 76. 9 %(20/ 26), and that of GP group was 50. 0 %(17/34) ; the difference was significant ( P < 0. 05) . The main toxicities included the alimentary t ract reaction and bone marrow depression were exist in combine GP group ; The Major toxicity in IRESSSA group is skin rash and diarrhea. Conclusion 　Gefitinib and GP regimen for advanced NSCLC have similar response rate ( P > 0. 05) . The former can get more clinical disease cont rol rate, and has lower toxicity. Gefitinib may be accepted as first line in the t reatment of patient s with bad constitution who is untolerable for chemotherapy.