OBJECTIVE： To observe the clinical efficacy and safety of Yifei qinghua granules combined with chemotherapy in the treatment of middle-advanced non-small cell lung cancer （NSCLC）. METHODS： 100 patients with middle-advanced NSCLC were selected and divided into control group and observation group according to random number table， with 50 cases in each group. Control group received vinorelbine+cisplatin or gemcitabine+cisplatin chemotherapy； observation group was additionally given Yifei qinghua granules 20 g dissolved in 200 ml warm water orally， tid， on the basis of control group. TCM syndrome integral were observed in 2 group before and after treatment， KPS score and SF-36 scale were used to evaluate the quality of life. The levels of TNF-α and sIL-2R clinical efficacies and the occurrence of ADR were compared between 2 groups. RESULTS： Total effective rate of observation group was 94.0％， which was significantly higher than 78.0％ of control group， with statistical significance （P＜0.05）.There was no statistical significance in TCM syndrome score， KPS score， SF-36 scale， the levels of TNF-α and sIL-2R of observation group before and after treatment （P＞0.05）. After treatment， TCM syndrome score， KPS score and SF-36 scale， the levels of TNF-α in 2 groups were increased significantly， and the observation group was significantly higher than the control group； the level of sIL-2R in 2 groups were decreased significantly， and the obcervation group was significantly lower than the control group， with statistical significance （P＜0.05）. The incidence of nausea and vomiting， myelosuppression， alopecia in observation group were significantly lower than in control group， with statistical significance （P＜0.05）. CONCLUSIONS： Yifei qinghua granules combined with chemotherapy is effective in the treatment of middle-advanced NSCLC， can promote the quality of life with good safety.