Objective To observe the effectiveness and safety of Kang′ai injection combined with docetaxel or gemcitabine chemotherapy in treatment of elderly patients with advanced non-small cell lung cancer(NSCLC). Methods A multi-center,randomized and parallel control study was carried out in 150 elderly patients with ad-vanced NSCLC treated in 3 hospitals during the period from June 2013 to August 2014.The patients were randomly divided into platinum-based group(platinum-based doublet chemotherapy)and Kang′ai group(Kang′ai injection combined with single agent chemotherapy). The clinical efficacy,quality of life and adverse reactions were ob-served and compared between the two groups. Results There was no significant difference in the disease control rate between the two groups group(79.66% vs 81.82%)(χ2=0.101,P=0.751)while the effective rate of Kang′ai group was significantly higher than that of platinum-based group(30.51% vs 14.29%)(χ2=5.240,P=0.022). The effective rate of clinical symptom relief in Kang′ai group after treatment was significantly higher than that in platinum-based group(69.49% vs 48.05%)(χ2=6.278,P=0.012),and the increase rate of PS score in Kang′ai group after the treatment was also significantly higher than that in platinum-based group(18.64% vs 3.90%)(χ2=7.868,P=0.005).There was no significant difference in quality of life between two groups(P>0.05).The quali-ty of life score of Kang′ai group was significantly higher than that of platinum-based group at the second course of treatment(P<0.05).The incidence of adverse reactions in Kang′ai group was significantly lower than that in the platinum-based group(47.46% vs 71.42%)(χ2= 8.070,P < 0.05). Conclusion Kang′ai injection combined with single agent chemotherapy can effectively relieve clinical symptoms and reduce the tumor size in elderly patients with advanced NSCLC,with high safety.