Objective To observe the efficacy and toxicity of Shenqi Fuzheng Injection（参芪扶正注射液） combined with chemotherapy for advanced non-small cell lung cancer（ NSCLC）. Methods Totally 82 cases of advanced NSCLC were randomized into the test group and control group

with 41 in each. The control group was given NP chemotherapy with intravenous infusion of vinorelbine 25 mg / m2on the 1st and 8th day and cisplatin（ DDP） 40 mg / m2from the 1st to 3rd day. The test group was added with 250 ml Shenqi Fuzheng Injection once daily from the 1st to 14th day. Both groups were treated for two periods with 21 days for one period. The T-lymphocyte subsets were determined before and after treatment. The Karnofsky Performance Status Scale（ KPS） was used to evaluate the quality of life（ QOL）. The size of tumor lesions was measured. The efficacy and toxicity was evaluated after treatment. Results The recent efficacy of the test group and control group was 46. 34% and 43. 90% respectively

with no significant difference between groups（ P > 0. 05）. The improvement rate of QOL in the test group and control group was 78. 05% and 56. 10% respectively

with a significant difference between groups（ P < 0. 05）. The percentage of CD4+was significantly increased in the test group after treatment（ P < 0. 05）. The percentages of CD3+and CD4+ and ratio of CD4+/ CD8+in the test group were significantly higher than those in the control group（ P < 0. 05）. The incidence of nausea

vomiting and leucopenia in the test group was significantly lower than that in the control group（P <0. 05）. Conclusion Shenqi Fuzheng Injection combined with chemotherapy is effective for advanced NSCLC. The combo therapy can improve immune function and QOL and reduce chemotherapy-induced toxicity.