Non Small Cell Lung CancerPhase 2FMT-LUNGNCT07432984
Fecal Microbiota Transplant(FMT) Combination With Tislelizumab in Advanced or Metastatic NSCLC
A Phase 2 study testing Tislelizumab and Fecal Microbiota Transplant(FMT) in people with Non Small Cell Lung Cancer, run by Se-Hoon Lee.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Tislelizumab and Fecal Microbiota Transplant(FMT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Oct 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Tislelizumab, Fecal Microbiota Transplant(FMT)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Also called Tevimbra
Tislelizumab 200mg IV q3wks
Fecal Microbiota Transplant(FMT)Procedure or surgery
FMT through colonoscopy q9wks up to 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplant(FMT) combination with Tislelizumab | Experimental | A fixed dose of 200mg Q3W Tislelizumab IV until PD And Q9W FMT (max 3) Receives: Drug: Tislelizumab; Procedure: Fecal Microbiota Transplant(FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety(SAE, AE)
to evaluate the clinical safety (by NCI-CTCAE v5.0)
Measured: From enrollment to the EOT, up to 42 months
Secondary outcomes (5)
ORR
To evaluate of clinical efficacy (by RECIST v1.1)
Measured: up to 42 months
OS
To evaluate of clinical efficacy (by Kaplan-Meier method)
Measured: up to 42 months
PFS
To evaluate of clinical efficacy (by Kaplan-Meier method)
Measured: up to 42 months
DCR
To evaluate of clinical efficacy (by RECIST v1.1)
Measured: up to 42 months
DOR
To evaluate of clinical efficacy (by RECIST v1.1)
Measured: up to 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Se-Hoon Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Se-Hoon Lee, Samsung Medical Center
- Investigators
- Sehoon Lee, Ph.MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432984
- Sponsor's protocol ID
- 2025-12-108
- Acronym
- FMT-LUNG
- Status last verified
- Aug 2026
- First submitted
- 5 Feb 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No