To observe the clinical effect of Kang’ai injection in treating middle-aged or elderly patients with non-small cell lung cancer(NSCLC). Methods: To randomly divided 40 cases of advanced NSCLC patients into treatment group(20 cases) and control group(20 cases). Both of the two groups were given conventional treatment and nutritional support. Treatment group was also given 60ml of Kang’ai injection intravenous infusion after diluted, once/d, 14d/period. After 4 periods of treatment, to observe the objective effect, living quality, Traditional Chinese Medicine(TCM) clinical symptoms and adverse reaction. Results: The carcinoma stable rate of treatment group is 70% and control group 55%, without statistical significance(P>0.05). After 4 periods of treatment, the physical strength of treatment group is obviously superior to control group(P<0.05). The TCM clinical symptoms curative effect of treatment group is better than control group without tatistical significance(P>0.05). Both of the two groups have no obvious hematologic and archenteric virulence. Conclusion: Kang’ai injection can improve the physical strength of middle-aged or elderly patients with advanced NSCLC, and it has no obvious adverse reaction. Therefore, it could be used in the add-on treatment of NSCLC.