Abstract: Objective To evaluate the clinical efficacy and safety of kanglaite combined with gefitinib in the treatment of mid-late stage lung cancer. Methods Randomized controlled trials(RCTS) involving kanglaite combined with gefitinib in the treatment of mid-late stage lung cancer that were published between the inception and January 11, 2025 were retrieved from Cochrane, PubMed, EMbase, Web of Science, CNKI, WANFANG and VIP database. Literature bias risk assessment was performed using the Cochrane Collaboration’s Risk of Bias 2.0 tool (ROB 2.0). RevMan 5.3 software was used for Meta-analysis. STATA12.0 software was used for sensitivity analysis and Egger's test. TSA 0.9.5.10 beta software was used for the trial sequential analysis (TSA). GRADE was used for quality evaluation of outcome indicators. Results Twelve trials involving 1 050 patients were included. ROB 2.0 results of all the studies included revealed some concerns. The results of Meta-analysis showed that the combination of Kanglaite and gefitinib in the treatment of mid-late stage lung cancer had significant advantages over gefitinib alone in clinical efficacy. Subgroup analysis showed that different dosage forms of kanglaite affected the heterogeneity of the disease control rate. Egger's test exhibited less publication bias. TSA indicated the possibility of false-positive results in the disease response rate, and more high-quality RCTs were needed to validate the efficacy. The results of the GRADE evaluation showed that the evidence quality of the outcome indicators in this study was low or exceedingly low. Conclusion Kanglaite combined with gefitinib in the treatment of advanced lung cancer is superior to the control group in improving efficacy, reducing gastrointestinal adverse reactions, improving quality of life, and the activity of immune cells, but more randomized controlled trials are needed for efficacy and safety evaluations .

Key words: Kanglaite, Gefitinib, Mid-Late Stage Lung Cancer, Meta-Analysis, Trial Sequential Analysis