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

Sponsor
Se-Hoon Lee
Study ID
NCT07432984
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Feb 25, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Oct 30, 2028
Completion
Oct 30, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fecal Microbiota Transplant(FMT) combination with Tislelizumab
    A fixed dose of 200mg Q3W Tislelizumab IV until PD And Q9W FMT (max 3)

Primary Outcome Measure

Safety(SAE, AE) [ Time Frame: From enrollment to the EOT, up to 42 months ]

Central Contacts

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