Clinical Trial

Fecal Microbiota Transplant(FMT) Combination With Tislelizumab in Advanced or Metastatic NSCLC

Study acronym: FMT-LUNG
Not Yet Recruiting Phase 2
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Summary
This study aims to investigate the efficacy and safety of fecal microbiota transplantation (FMT) as a treatment for non-small cell lung cancer (NSCLC) patients whose disease has progressed after immune checkpoint inhibitor (ICI) therapy, and to establish the foundation for personalized FMT through gut microbiome analysis. Recovering immune responses in patients who have failed prior immunotherapy remains an unmet clinical need. This study aims to provide evidence to address this issue. Fecal microbiota transplantation (FMT) is a means that can rapidly and efficiently change the intestinal microbiota and has the potential to affect the systemic immune environment. Therefore, this study intends to contribute to the development of future treatment strategies by evaluating whether FMT can restore the immune response and clinical efficacy in patients with immune checkpoint inhibitor-resistant NSCLC.
Trial Details
NCT Number NCT07432984
Lead Sponsor Se-Hoon Lee
Conditions Non Small Cell Lung Cancer
Enrollment 15 participants
Start Date 2026-09-30
Primary Completion 2028-10-30 (estimated)
Study Completion 2029-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-11