Objective To explore clinical efficacy and safety of comprehensive traditional Chinese medicine（TCM） therapeutic scheme in maintenance treatment for advanced non-small cell lung cancer（NSCLC）. Methods A multicenter

large-sample

prospective cohort study was conducted. After 2-4 cycles of chemotherapy

patients entering the maintenance stage with efficacy evaluation of stable disease（SD） and above were enrolled into two groups according to their intention

including 126 cases in treatment group and 123 cases in control group. The maintenance treatment in the control group was given chemotherapy drugs. The maintenance treatment of comprehensive TCM therapeutic scheme including decoctions

injections of Chinese materia medica and Chinese patent medicine was performed to the treatment group. One course of treatment was 21-28 days

and groups received the intervention for no less than 2 courses of treatment. Disease progression-free survival（PFS）

median overall survival（OS） and quality of life were compared between groups

and drug safety was evaluated at the same time. Results PFS outcome events occurred in 229 patients（91.97%）

with 114 cases in the treatment group（median PFS 152 days） and 115 cases in the control group（median PFS 161 days）. There was no statistically significant difference in PFS between groups（P>0.05）. There were 134 patients dead in the two groups

with 62 cases in the treatment group（median OS 593 days） and 72 cases in the control group（median OS 518 days）. There was no statistically significant difference in OS between groups（P>0.05）. The quality of life scores at each point-in-time in the treatment group were improved after the treatment（P<0.05）

and they were higher than those at the same point-in-time in the control group（P<0.01）. Adverse reactions occurred in 45 patients in the 2 groups during the treatment

with 33 patients in the control group（44 adverse events） and 12 patients in the treatment group（12 adverse events）. The incidence of adverse events in the treatment group was lower than that in the control group（P<0.05）. Conclusion In terms of extension of survival time

the efficacy of maintenance treatment by comprehensive TCM therapeutic scheme for advanced NSCLC is not inferior to the maintenance effect of modern medical chemotherapy

and the comprehensive TCM therapeutic scheme has advantages of higher quality of life and lower adverse reactions.