Abstract: Objective To evaluate the clinical effect and toxicity of combined gemcitabine with Xiaoaiping injection for the initial treatment of advanced non-small cell lung cancer(NSCLC).Methods 76 cases of advanced NSCLC patients(Ⅲ B-Ⅳ period)were divided into combined group of Xiaoaiping injection and GP regimen(test group)or GP group(control group).All the patients had accepted GP regimen or Xiaoaiping injection with GP regimen at least 2 cycles.A clinical observation on short term effectiveness, adverse effects and the 1-, 2-year survival rate were carried out in two groups.Results The short term effective rate for advanced NSCLC in GP group and combined group of Xiaoaiping injection and GP regimen was 52.63%and 47.36%, respectively.The median survival time was 8.9 months and 8.7 months, respectively.1-year survival rate was 45.2%and 43.5%, respectively.2-year survival rate was 22.9%and 23.4%, respectively.The short term effectiveness and the 1-, 2-year survival rate in two groups had no statistically significant difference(P＞0.05).The life quality of patients in test group is superior to the patients in control group(P＜0.05).In the adverse effects of treatment, the major cytotoxicity was tolerable.Conclusion Combined gemcitabine with Xiaoaiping injection can improve the curative effect and lower toxicity of advanced non-small cell lung cancer and the patients life quality, as well as enhancing the immune function.