drugset / Trial / NCT07432984

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

NCT07432984 ↗

Phase 2 Not yet recruiting 15 enrolled Se-Hoon Lee
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-04-30
Primary completion
2028-10-30
Completion
2029-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous