ObjectiveTo evaluate the clinical efficacy and toxicity of gefitinib combined with Zhenqi Fuzheng capsule in treatment of senile non-small-cell lung cancer (NSCLC) at the middle and late stages. Methods88 patients with NSCLC at Ⅲ b-Ⅳ were randomly divided into combined drugs group ( gefitinib combined Zhenqi Fuzheng capsule,n =46 cases) and single drug group (gefitinib,n=42 cases).After treatment for 60 d,the short-term efficacy,side effects and quality of life were observed and evaluated. The objective response and survival rate were assessed after following up for 2 years. Results The short-term efficacy rate in the combined drugs group (19.6 ％ ) was higher than single drug group (11.9 ％ ),but there was no significant difference between the two groups (x2=0.096,P＞0.05).The rate of Karnofsky score in improvement and stableness was 71.7％ in combined drugs group and 50.0％ in single drug group,and quality of life improved after combined drugs compared with single drug treatment (x2 =4.376,P＜0.05).The adverse effects in combined drugs group was some lower than in single drug group with no statistical significance.There was no differences in the survival rates of 2 years between the two groups(x2 =0.556,P＞0.05). ConclusionsThe gefitinib combined Zhenqi Fuzheng capsule in treatment of middle-and late-stage NSCLC is worthy to be popularized due to positive efficacy,less side effects and higher quality of life.