OBJECTIVE： To investigate clinical efficacy and safety of Kang’ai injection adjuvant chemotherapy for advanced lung cancer. METHODS： A total of 146 patients with advanced lung cancer during May 2013-Apr. 2014 were divided into observation group and control group according to odd-even admission number， with 73 cases in each group. Control group was given GP （gemcitabine+cisplatin） chemotherapy. Observation group was additionally given Kang’ai injection 60 mL added into normal saline 250 mL， qd， ivgtt， for consecutive 14 d each chemotherapy cycle， on the basis of control group. Both groups were given tropisetron 5 mg for preventing gastrointestinal reaction during chemotherapy. A treatment course lasted for 3 weeks， and both groups were treated for 3 courses. Clinical efficacies of 2 groups were compared； the levels of serum inflammatory factors （hs-CRP， TNF-α， IFN-γ， IL-10）， immune function indexes （CD3+， CD4+， CD8+， CD4+/CD8+） and tumor markers （SCC-Ag， CEA， CA50， CA72-4） were compared before and after treatment. The occurrence of ADR were recorded in 2 groups. RESULTS： The response rate and disease control rate of observation group were 39.73％ and 84.93％， which were significantly higher than 23.29％ and 71.23％ of control group， with statistical significance （P＜0.05）. Before treatment， there was no statistical significance in the levels of serum inflammatory factors， immune function indexes or tumor markers between 2 groups （P＞0.05）. After treatment， the levels of hs-CRP， TNF-α and IFN-γ in 2 groups were significantly lower than before treatment， while the level of IL-10 was significantly higher than before treatment； above indexes of observation group were significantly better than control group， with statistical significance （P＜0.05）. The levels of CD4+ and CD4+/CD8+ in control group were decreased significantly and lower than observation group， with statistical significance （P＜0.05）. Serum levels of SCC-Ag， CEA， CA50 and CA72-4 in 2 groups were decreased significantly， and observation group was significantly lower than control group， with statistical significance（P＜0.05）. The incidence of thrombocytopenia， neutropenia， abnormal liver function， nausea and vomiting， anemia in observation group were significantly lower than control group， with statistical significance （P＜0.05）. CONCLUSIONS： Kang’ai injection adjuvant chemotherapy can effectively relieve inflammation symptoms of patients with advanced lung cancer， reduce toxic reactions， enhance immune function， and improve short-term therapeutic efficacy with good safety.