NCT07432984

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

Efficacy and Safety of Fecal Microbiota Transplant(FMT) Combination With Tislelizumab in Advanced or Metastatic Non-Small Cell Lung Cancer Whose Disease Has Progressed After Prior Immune Checkpoint Inhibitors

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Se-Hoon Lee · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Detailed description

The most significant improvement in response rates has been demonstrated by whole microbiome intervention via fecal microbiota transplantation (FMT) has demonstrated the most significant improvement in response rates compared to individual species-based interventions. In light of the established clinical efficacy of ICIs and FMT in patients with solid malignancies, a phase II study was designed to investigate the potential of FMT in restoring clinical efficacy in patients who have failed ICI treatment. This study is planning to register 10 donors and 15 recipients.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab 200mg IV q3wks
PROCEDURE	Fecal Microbiota Transplant(FMT)	FMT through colonoscopy q9wks up to 3 cycles.

Timeline

• Start date: 2026-04-30
• Primary completion: 2028-10-30
• Completion: 2029-10-30
• First posted: 2026-02-25
• Last updated: 2026-02-25