Fecal Microbiota Transplantation to Improve Efficacy of Immune Checkpoint Inhibitors in Metastatic Lung Cancer

What this Trial Is About

Researchers are investigating whether adding Fecal Microbiota Transplant (FMT) to standard first-line (chemo-)immunotherapy can improve treatment response in patients with metastatic lung cancer. The study aims to evaluate the safety and effectiveness of FMT combined with immune checkpoint inhibitors, focusing on changes in the gut microbiome and how these may influence cancer control. This Phase 2 clinical trial addresses the need to overcome resistance to immunotherapy by exploring the modifiable gut microbiome as a potential therapeutic target. Participants will be randomly assigned to one of two groups: one receiving standard-of-care (chemo-)immunotherapy plus FMT capsules, and the other receiving standard-of-care treatment alone. The FMT capsules, produced from donors who had a full response to immunotherapy, will be taken orally with a regimen of ten capsules in the morning and ten in the afternoon on the first day of the first treatment cycle, then every three weeks. Prior to FMT, participants will receive antibiotics to prepare the bowel. The study includes active monitoring and analysis of microbiome samples and blood tests throughout treatment. During the study, participants will undergo regular assessments including imaging, laboratory tests, vital signs monitoring, and disease status evaluations. Stool and blood samples will be collected at various time points to analyze microbiome composition and immune responses. The main outcome measured is progression-free survival over two years, with additional outcomes including overall survival, disease control rate, microbiome changes, serum antibody levels, lymphocyte profiles, and safety. Follow-up will continue until the study ends in mid-2028, allowing for comprehensive evaluation of FMT's impact alongside immunotherapy.

Fecal Microbiota Transplantation With Immune Checkpoint Inhibitors in Lung Cancer