To observe the short-term efficacy and safety of compound Kushen injection combined with gemcitabine plus cisplatin in the treatment of advanced non-small cell lung cancer. Methods:Eighty patients with advanced non-small cell lung cancer (NSCLC) in our hospital were enrolled in this study from May 2015 to December 2016. They were randomly divided into observation group and control group, with 40 patients in each group. According to the international stage of lung cancer, The control group had 19 patients with stage III and 21 patients with stage IV, and the study group had 20 patient with stage III and stage IV respectively. The patients in the control group were given gemcitabine combined with cisplatin (GP) chemotherapy regimen. The study group was treated with compound Kushen injection on the basis of chemotherapy. After 2 cycles of treatment, tumor control and chemotherapy adverse reactions of two groups were compared. Results:There was no significant difference in the effective rate and control rate of patients with different stages in the control group (χ2=0.178 8, P=0.672 4>0.05; χ2=0.058 5, P=0.808 9>0.05). There was no significant difference in the effective rate and control rate of III and IV stage patients between the two groups (P>0.05). Compared with patients with different stages in study group, the number of patients with III stage who had toxic reaction was less, but there was no significant difference (P>0.05). There was no significant difference in the number of toxic reactions between two stages in the control group (P>0.05). The number of toxic reactions of III and IV stage patients in the study group was lower than that in the control group, and the difference was statistically significant (P<0.05). Conclusion:Combination therapy of compound Kushen injection can improve the anti-tumor effect of advanced non-small cell lung cancer in elderly patients, which can effectively reduce the side effects of chemotherapy and improve the quality of life of patients. It is worthy of clinical use and further observation.