PT - JOURNAL ARTICLE AU - Wei, Yanshuang AU - Qin, Lanqun AU - Wu, Xinyu AU - Li, Dongqing AU - Qian, Danping AU - Jiang, Hua AU - Geng, Qian TI - Faecal microbiota transplantation combined with platinum-based doublet chemotherapy and tislelizumab as first-line treatment for driver-gene negative advanced non-small cell lung cancer (NSCLC): study protocol for a prospective, multicentre, single-arm exploratory trial AID - 10.1136/bmjopen-2024-094366 DP - 2025 Mar 01 TA - BMJ Open PG - e094366 VI - 15 IP - 3 4099 - http://bmjopen.bmj.com/content/15/3/e094366.short 4100 - http://bmjopen.bmj.com/content/15/3/e094366.full SO - BMJ Open2025 Mar 01; 15 AB - Introduction The standard first-line treatment for driver-gene negative advanced non-small cell lung cancer (NSCLC) is chemotherapy combined with immunotherapy. However, owing to the immune microenvironment imbalance and immune status impairment caused by repeated chemotherapy, as well as the primary or secondary resistance to immune checkpoint inhibitors, the efficacy of immunotherapy combined with chemotherapy remains unsatisfactory. Recent studies have shown that faecal microbiota transplantation (FMT) can modulate the intestinal microflora, influence the tumour immune microenvironment and even enhance the efficacy of immunotherapy. Hence, we conduct such a prospective, exploratory study to evaluate the efficacy and safety of integrating FMT with standard first-line treatment in patients with driver-gene negative advanced NSCLC.Methods and analysis FMT-JSNO-02 (NCT06403111) is a prospective, multicentre, single-arm exploratory study. It is planned to include 62 cases of previously untreated driver-gene negative, Eastern Cooperative Oncology Group Performance Status 0–1, programmed death ligand 1<50% advanced NSCLC patients, who will be given FMT by orally ingested stool capsules on the basis of standard first-line treatment of chemotherapy combined with immunotherapy. The primary endpoint of this study is the 12-month progression-free survival rate.Ethics and dissemination The study was approved by the ethics committee of the Second People’s Hospital of Changzhou (number [2024] YLJSA005) and is being conducted in accordance with the principles of the Declaration of Helsinki. The results of this study will be disseminated through publication in a peer-reviewed journal and presentation at scientific conferences.Trial registration number NCT06403111. Date of registration: 7 May 2024, the first version protocol.