Objective:To evaluate the clinical efficacy of Fuzheng Kangyan Formula combined with gefitinib on non-small cell lung cancer (NSCLC) (stage IV) of the qi deficiency and blood stasis type. Methods60 patients were randomly assigned into control group and treatment group, 30 patients in each group. The control group was given gefitinib + placebo and the treatment group received gefitinib + Fuzheng Kangyan Formula. Drugs were given until tumor progression. The short- and long-term efficacy (progress-free survival, PFS), changes in KPS score and adverse reactions were observed and compared.  Results:①There were no drop-outs during the trial. ②The effective rate and tumor control rate were 53.33% and 93.33% respectively in the treatment group and 43.33% and 90.00% respectively in the control group. There was no statistically significant difference in short-term efficacy between the groups (P>0.05). ③There was statistically significant difference in PFS between the groups, which was longer in the treatment group than in the control group (P<0.05). ④After treatment, the KPS score was significantly higher in the treatment group than in the control group (P<0.05). ⑤Severity of adverse reactions including diarrhea, nausea and vomiting was significantly different, which was obviously lower in the treatment group than in the control group (P<0.05).