Objective To observe the efficacy and safety of Shenmai injection combined with amitinib in the treatment of advanced non-small cell lung cancer with EGFR mutation,and to explore the application value of this combined regimen.Methods Sixty patients with advanced NSCLC with positive EGFR mutation were enrolled in the Department of Respiratory and Critical Care and Department of Oncology,Affiliated Hospital of Hangzhou Normal University from January 2020 to December 2022.They were randomly divided into the observation group and the control group according to random number table method.Amitinib combined with Shenmai injection was observed and treated in the control group,with 30 patients in each group.Results The Objective Response rate(ORR)and Disease control rate(DCR)of the observation group were significantly higher than those of the control group(P<0.05).After the treatment,the KPS scores of the observation group and the control group were higher than those before the treatment(P<0.05),and the difference of KPS scores before and after the treatment showed that the treatment group(20.00±13.13)was significantly higher than that of the control group(11.00±10.23)(P<0.05).In terms of safety,the incidence of rash,leukopenia and thrombocytopenia in the observation group was significantly lower than that in the control group(P<0.05).Conclusion Amitinib combined with Shenmai injection can improve ORR and DCR of patients with advanced NSCLC with positive EGFR mutation,and improve their quality of life and reduce the occurrence of adverse reactions.