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NCT07432984Not yet recruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 11 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
15 (estimated)
First submitted
5 Feb 2026
Start date
30 Sept 2026
Primary completion date
30 Oct 2028
Lead sponsor
Se-Hoon Lee
Diseases
Lung cancer
NCT number
NCT07432984

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 15
  • From 30 Sept 2026 to the primary completion date, 30 Oct 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • DONOR
    • Have voluntarily provided written Informed consent to participate in this clinical trial
    • Adults aged 19 years or older
    • Histologically or cytologically confirmed progressive or metastatic NSCLC
    • Subjects with at least one measurable lesion according to RECIST v1.1
    • Subjects who have received one or more chemotherapy treatments and have experienced disease progression after prior immunotherapy (However, patients with confirmed EGFR or ALK mutations must have shown progression after approved targeted therapies.) ⑥ ECOG 0-1
    • Subjects with a life expectancy is at least 3 months
    • Subjects with adequate bone marrow and organ function within 14 days prior to study treatment, defined as:
    • 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)
    • 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
    • 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
    • Agreed to provide blood and fecal samples during the trial period
  • RECIPIENT
    • Have voluntarily provided written Informed consent to participate in this clinical trial
    • Adults aged 19 years or older
    • Histologically or cytologically confirmed progressive or metastatic NSCLC
    • Subjects with at least one measurable lesion according to RECIST v1.1
    • Subjects who have received one or more chemotherapy treatments and have experienced disease progression after prior immunotherapy (However, patients with confirmed EGFR or ALK mutations must have shown progression after approved targeted therapies.)
    • ECOG 0-1 ⑦ Subjects with a life expectancy is at least 3 months
    • Subjects with adequate bone marrow and organ function within 14 days prior to study treatment, defined as:
    • 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)
    • 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
    • Agreed to provide blood and fecal samples during the trial period

Who the study is looking for

  • DONOR
    • ① Subjects who have voluntarily provided written Informed consent to participate in this clinical trial
    • ② Aged of 19 or older
    • ③ Subjects who meet one of the following 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
  • RECIPIENT
    • Have voluntarily provided written Informed consent to participate in this clinical trial
    • Adults aged 19 years or older
    • Histologically or cytologically confirmed progressive or metastatic NSCLC
    • Subjects with at least one measurable lesion according to RECIST v1.1
    • Subjects who have received one or more chemotherapy treatments and have experienced disease progression after prior immunotherapy (However, patients with confirmed EGFR or ALK mutations must have shown progression after approved targeted therapies.)
    • ECOG 0-1
    • Subjects with a life expectancy is at least 3 months ⑧ Subjects with adequate bone marrow and organ function within 14 days prior to study treatment, defined as:
    • 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
    • ⑪ Agreed to provide blood and fecal samples during the trial period

Age in the registry: 19 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.