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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07432984
- Acronym / sponsor ID
- FMT-LUNG / 2025-12-108
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Se-Hoon LeeUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplant(FMT) combination with Tislelizumab | Experimental | Drug: Tislelizumab, Procedure: Fecal Microbiota Transplant(FMT)A fixed dose of 200mg Q3W Tislelizumab IV until PD And Q9W FMT (max 3) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- DONOR
- ① Subjects who have voluntarily provided written Informed consent to participate in this clinical trial
- ② Aged of 19 or older
- RECIPIENT
- ⑪ Agreed to provide blood and fecal samples during the trial period
Key exclusion criteria (33 listed)
- DONOR
- RECIPIENT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabAlso: TevimbraTislelizumab 200mg IV q3wks | Drug | Fecal Microbiota Transplant(FMT) combination with Tislelizumab |
| Fecal Microbiota Transplant(FMT)FMT through colonoscopy q9wks up to 3 cycles. | Procedure or surgery | Fecal Microbiota Transplant(FMT) combination with Tislelizumab |
Primary outcome
Safety(SAE, AE)
Time frame: From enrollment to the EOT, up to 42 months
to evaluate the clinical safety (by NCI-CTCAE v5.0)
5 secondary outcomes
ORR
Time frame: up to 42 months
OS
Time frame: up to 42 months
PFS
Time frame: up to 42 months
DCR
Time frame: up to 42 months
DOR
Time frame: up to 42 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sehoon Lee, Ph.MD principal investigator
Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab and Fecal Microbiota Transplant(FMT) in people with Non Small Cell Lung Cancer, run by Se-Hoon Lee.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sehoon Lee, Ph.MD (+82-2-3410-3459, sehoon.lee119@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety(SAE, AE) (time frame: From enrollment to the EOT, up to 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.