Abstract：Objective：To observe the clinical effect of YiqiYangyinJiedu prescription for non-small cell lung cancer at Ⅳ stage. Methods：A total of 95 cases of patients with non- small cell lung cancer at Ⅳ stage were randomly divided into the treatment group and the control group， 48 and 47 cases in each group respectively. The control group was given routine chemotherapy including cisplatin and gemcitabine， and the treatment group was additionally given oral administration of YiqiYangyinJiedu prescription based on the treatment of the control group. Both groups were treated for two courses， three weeks being a course. The clinical effect，improvement of Chinese medicine syndrome，Chinese medicine symptom scores， Karnofsky score， quality of life， physical fitness， as well as changes in serum tumor markers including carcinoembryonic antigen(CEA)，carbohydrate antigen 125(CA125) and carbohydrate antigen 19- 9(CA19- 9) were observed and compared between the two groups. Results：The disease control rate was 81.25% in the treatment group，and 61.70% in the control group，the difference being significant(P＜0.05). The total effective rate of improvement of Chinese medicine symptoms was 89.58% in the treatment group，and 72.34% in the control group，the difference being significant(P＜0.05). After treatment，Chinese medicine symptom scores，scores of physical fitness，levels of CEA，CA125，and CA19-9 in the two groups were significantly decreased when compared with those before treatment(P＜0.05)；Karnofsky scores and scores of quality of life were significantly increased(P＜0.05). After treatment， the improvement of Chinese medicine symptom scores，Karnofsky score，scores of quality of life and physical fitness，and CA19-9 level in the treatment group was more significant than that in the control group(P＜0.05)；there was no significant difference being found in the comparison of levels of CEA and CA125(P＞0.05). When compared the incidence of leukopenia，vomiting，and nausea between the two groups， there was significance in the difference(P＜0.05). When compared the incidence of thrombopenia， the liver function impairment，and poor appetite between the two groups，there was no significance in the difference(P＞0.05). Conclusion： The therapy of YiqiYangyinJiedu prescription combined with chemotherapy has significant curative effect on non- small cell lung cancer at Ⅳ stage， which conduces to controlling disease condition， improving quality of life and physical fitness， reliving symptoms，as well as reducing CA19-9 level and incidence of adverse reactions.