Objective:To systematically review the current registered clinical study schemes in China regarding the combination of TCM and targeted drug therapy for lung cancer; To analyze their strengths and weaknesses; To provide reference for future study.Methods:Chinese Clinical Trial Registry for clinical study schemes combining TCM with targeted drug therapy for lung cancer treatment was retrieved from the inception to July 10, 2024. The general characteristics, study types, intervention measures, and outcome indicators of existing schemes were systematically summarized and analyzed.Results:A total of 15 studies were included, with the earliest study registered in 2013. Registration locations were concentrated in Shanghai, Guangdong, Tianjin, and Zhejiang. Among them, 9 studies received funding from local, national finance, or hospitals; 13 studies passed ethical review, and 12 included informed consent. The design schemes included 10 randomized controlled studies, 1 cohort study, 1 interventional single-arm study, and 3 observational studies. 6 studies had a sample size smaller than 100 cases, and most were single-center trials. Intervention measures primarily involved the combination of Chinese patent medicine or TCM with targeted drugs, with evaluation indicators mainly focusing on clinical symptoms and laboratory indicators. The setting of outcome indicators lacked a unified standard.Conclusions:Since 2013, clinical studies combining TCM with targeted drug therapy for lung cancer have been relatively methodologically sound but face challenges such as small sample sizes and a certain degree of regional concentration, leading to relatively insufficient representativeness. The future direction for improvement lies in multi-center, large-sample, and well-designed clinical trials. It is also necessary to establish a standardized and normalized system for evaluating outcomes. Integrating basic research to clarify the mechanisms of TCM can provide a theoretical basis for the combination of TCM and targeted drugs, which is conducive to enhancing the rigor and scientific nature of clinical trial design and promoting the formation of high-level evidence-based medicine.

Traditional Chinese medicine (TCM) is considered an important complementary therapy with beneficial effects for cancer patients. Elderly patients with non-small-cell lung cancer (NSCLC) are a complex patient group with increasing co-morbidity and shrinking physiological reserve, and may derive substantial benefit from the supportive aspects of TCM. Researchers from Shanghai Longhua Hospital found that qi and yin deficiency is a common syndrome in patients with stage III or IV lung cancer. This project was designed to study the combination of single-agent chemotherapy with TCM methods of benefiting qi and yin in elderly patients with advanced NSCLC.

From the development of national clinical research base of traditional Chinese medicine ( TCM ) in Longhua Hospital, Shanghai University of Traditional Chinese Medicine, we made a success of construction, such as planning and foundation , curative effect , study protocol , standards , platform establishment . From the thinking to results , we made knowledge of the situation in order to provide references for the further building of clinical research base of TCM .