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Fecal Microbiota Transplant(FMT) / Tislelizumab / Non Small Cell Lung Cancer · Phase 2 Trial
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 2 trial of fecal microbiota transplant combined with tislelizumab in patients with advanced or metastatic NSCLC resistant to prior immunotherapy. The study has not yet begun recruitment and no outcome data are available. The hypothesis is that FMT may restore immune responsiveness in ICI-refractory disease, but this remains exploratory and unproven.
Phase 2, Interventional, Single Group, Open label, Treatment purpose. Non Small Cell Lung Cancer; age from 19 Years; accepts healthy volunteers. Intervention: Fecal Microbiota Transplant(FMT) combination with Tislelizu…. n = 15.
This is a planned Phase 2 trial of fecal microbiota transplant combined with tislelizumab in patients with advanced or metastatic NSCLC resistant to prior immunotherapy. The study has not yet begun recruitment and no outcome data are available. The hypothesis is that FMT may restore immune responsiveness in ICI-refractory disease, but this remains exploratory and unproven.
No efficacy endpoints reported; primary focus is safety and tolerability at this stage.
This trial is exploratory and addresses an important unmet need in ICI-refractory NSCLC. Clinicians should await results before considering FMT as a treatment strategy; the small sample size and early phase mean any findings will require confirmation in larger studies.
This is a Phase 2 registry record for an unstarted trial with planned enrollment of 15 participants; no results are posted, making it early-stage feasibility work.
As stated by the source record.
Quoted from the source exactly as published.
This trial is exploratory and addresses an important unmet need in ICI-refractory NSCLC. Clinicians should await results before considering FMT as a treatment strategy; the small sample size and early phase mean any findings will require confirmation in larger studies.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07432984). This is a study registration, not published results. Lead sponsor: Se-Hoon Lee. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 15 participants (ESTIMATED). Conditions: Non Small Cell Lung Cancer. Interventions: DRUG: Tislelizumab; PROCEDURE: Fecal Microbiota Transplant(FMT). Primary outcome measures: Safety(SAE, AE) , From enrollment to the EOT, up to 42 months. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.