Not Yet RecruitingPhase 2

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

15 participantsStarted 2026-04-30

Plain-language 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.

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. Patients with histologically confirmed NSCLC who have maintained a clinical benefit(partial response, PR) for more than 1 year through immune checkpoint inhibitor therapy
✓. Healthy volunteers with no history of inflammatory bowel disease ④ Subjects who agree to provide repetitive blood and fecal samples during the trial period
✓. Absolute neutrophil count (ANC): ≥ 1.5×109/L
✓. Hemoglobin: ≥ 9.0 g/dL
✓. Platelet count: ≥ 75×109/L
✓. Serum creatinine ≤ 1.5×ULN or CrCl ≥ 30 mL/min as determined by Cockcroft-Gault
✓. AST(SGOT)/ALT(SGPT): ≤ 3×ULN (≤ 5×ULN in the presence of liver metastases)
✓. Total bilirubin: ≤ 1.5×ULN (\< 3×ULN for Gilbert's syndrome(unconjugated hyperbilirubinemia) or liver metastases) ⑨ Female Subjects must be using a highly effective method of contraception during the clinical trial and for 4months after permanent discontinuation of the study drug ⑩ Male Subjects must be using highly effective method of contraception during the clinical trial and for 4months after permanent discontinuation of the study drug and refrain from sperm donation

Exclusion criteria

What they're measuring

Safety(SAE, AE)

Timeframe: From enrollment to the EOT, up to 42 months

Trial details

NCT IDNCT07432984

SponsorSe-Hoon Lee

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-10-30

Contact for this trial

Sehoon Lee, Ph.MD

+82-2-3410-3459 sehoon.lee119@gmail.com

View on ClinicalTrials.gov More Non Small Cell Lung Cancer trials