Objective: To evaluate the efficacy and safety of specialized TCM (traditional Chinese medicine) prescription integrated with chemotherapy in the treatment of stages III-IV NSCLC (non-small cell lung cancer). Methods: The relevant research literatures of randomized controlled trials (RCTs) were retrieved from the electronic databases of China National Knowledge Infrastructure (CNKI), VIP Information (VIP), and Chinese Biomedical Literature (CBM). These literatures were then screened according to the inclusion and exclusion criteria. The quality of each research was assessed and a systematic review was performed on the extracted data using the meta-analysis software RevMan 5.2.3 provided by Cochrane Collaboration. Results: Total of 17 RCTs (randomized controlled trials) including 1 163 cases were included in this Meta analysis. As compared with chemotherapy alone group (control group), the specialized TCM prescription integrated with chemotherapy group (treatment group) achieved significant benefits in improving clinical response rate and quality of life and reducing adverse effects. The OR s (odds ratios) for clinical response rate, improvement of quality of life and the rates of adverse effects were 1.44 (95% confidence interval: 1.12-1.85), 3.36(95% confidence interval: 2.45-4.59) and 0.23 (95% confidence interval: 0.18-0.28), respectively. Conclusion: The results of this Meta analysis indicate that the specialized TCM prescription integrated with chemotherapy in the treatment of stages ?-? NSCLC is more effective than chemotherapy alone, but because the RCTs reviewed in this study have not yet fulfilled the strict requirements of evidence-based medicine, therefore more well-designed RCTs involving large sample, multicenter, and high quality methodology are required to support and ascertain such findings. Copyright © 2013 by TUMOR.