[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626234":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":33,"locations":28,"responsibleParty":38,"collaborators":28,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":28,"enrollmentInfo":53,"targetDuration":28,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":28,"overallStatus":62,"whyStopped":28,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":28},{"fullName":5,"class":6},"Samsung Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fecal Microbiota Transplant(FMT) combination with Tislelizumab","EXPERIMENTAL","A fixed dose of 200mg Q3W Tislelizumab IV until PD And Q9W FMT (max 3)",[13,14],"Drug: Tislelizumab","Procedure: Fecal Microbiota Transplant(FMT)",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Tislelizumab","Tislelizumab 200mg IV q3wks",[9],[22],"Tevimbra",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"PROCEDURE","Fecal Microbiota Transplant(FMT)","FMT through colonoscopy q9wks up to 3 cycles.",[9],null,[30],{"name":31,"affiliation":5,"role":32},"Sehoon Lee, Ph.MD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":28,"email":37},"CONTACT","+82-2-3410-3459","sehoon.lee119@gmail.com",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","Se-Hoon Lee","Principal Investigator","100626234","phase-2-fecal-microbiota-transplantfmt-combination-with-tislelizumab-in-advanced-or-metastatic-nsclc-100626234",false,"NCT07432984","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","FMT-LUNG","Inclusion Criteria:\n\n* DONOR\n\n  ① Subjects who have voluntarily provided written Informed consent to participate in this clinical trial\n\n  ② Aged of 19 or older\n\n  ③ Subjects who meet one of the following criteria:\n  1. Patients with histologically confirmed NSCLC who have maintained a clinical benefit(partial response, PR) for more than 1 year through immune checkpoint inhibitor therapy\n  2. Healthy volunteers with no history of inflammatory bowel disease ④ Subjects who agree to provide repetitive blood and fecal samples during the trial period\n* RECIPIENT\n\n  * Have voluntarily provided written Informed consent to participate in this clinical trial\n\n    * Adults aged 19 years or older\n\n      * Histologically or cytologically confirmed progressive or metastatic NSCLC\n\n        * Subjects with at least one measurable lesion according to RECIST v1.1\n\n          * 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.)\n\n            * ECOG 0-1\n\n              * 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:\n\n                1. Absolute neutrophil count (ANC): ≥ 1.5×109\u002FL\n                2. Hemoglobin: ≥ 9.0 g\u002FdL\n                3. Platelet count: ≥ 75×109\u002FL\n                4. Serum creatinine ≤ 1.5×ULN or CrCl ≥ 30 mL\u002Fmin as determined by Cockcroft-Gault\n                5. AST(SGOT)\u002FALT(SGPT): ≤ 3×ULN (≤ 5×ULN in the presence of liver metastases)\n                6. Total bilirubin: ≤ 1.5×ULN (\\\u003C 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\n\n                   ⑪ Agreed to provide blood and fecal samples during the trial period\n\nExclusion Criteria:\n\n* DONOR\n\n  * Have voluntarily provided written Informed consent to participate in this clinical trial\n\n    * Adults aged 19 years or older\n\n      * Histologically or cytologically confirmed progressive or metastatic NSCLC\n\n        * Subjects with at least one measurable lesion according to RECIST v1.1\n\n          * 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\n\n            * Subjects with a life expectancy is at least 3 months\n\n              * Subjects with adequate bone marrow and organ function within 14 days prior to study treatment, defined as:\n\n                1. Absolute neutrophil count (ANC): ≥ 1.5×109\u002FL\n                2. Hemoglobin: ≥ 9.0 g\u002FdL\n                3. Platelet count: ≥ 75×109\u002FL\n                4. Serum creatinine ≤ 1.5×ULN or CrCl ≥ 30 mL\u002Fmin as determined by Cockcroft-Gault\n                5. AST(SGOT)\u002FALT(SGPT): ≤ 3×ULN (≤ 5×ULN in the presence of liver metastases)\n                6. Total bilirubin: ≤ 1.5×ULN (\\\u003C 3×ULN for Gilbert's syndrome(unconjugated hyperbilirubinemia) or liver metastases)\n\n                   * 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\n\n                     * 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\n\n                       * Agreed to provide blood and fecal samples during the trial period\n* RECIPIENT\n\n  * Have voluntarily provided written Informed consent to participate in this clinical trial\n\n    * Adults aged 19 years or older\n\n      * Histologically or cytologically confirmed progressive or metastatic NSCLC\n\n        * Subjects with at least one measurable lesion according to RECIST v1.1\n\n          * 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.)\n\n            * ECOG 0-1 ⑦ Subjects with a life expectancy is at least 3 months\n\n              * Subjects with adequate bone marrow and organ function within 14 days prior to study treatment, defined as:\n\n                1. Absolute neutrophil count (ANC): ≥ 1.5×109\u002FL\n                2. Hemoglobin: ≥ 9.0 g\u002FdL\n                3. Platelet count: ≥ 75×109\u002FL\n                4. Serum creatinine ≤ 1.5×ULN or CrCl ≥ 30 mL\u002Fmin as determined by Cockcroft-Gault\n                5. AST(SGOT)\u002FALT(SGPT): ≤ 3×ULN (≤ 5×ULN in the presence of liver metastases)\n                6. Total bilirubin: ≤ 1.5×ULN (\\\u003C 3×ULN for Gilbert's syndrome(unconjugated hyperbilirubinemia) or liver metastases)\n\n                   * 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\n\n                     * Agreed to provide blood and fecal samples during the trial period",true,"ALL","19 Years",{"count":54,"type":55},15,"ESTIMATED","INTERVENTIONAL",[58],"PHASE2","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.\n\nRecovering 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.",[61],"Non Small Cell Lung Cancer","NOT_YET_RECRUITING","2026-02-18",{"date":65,"type":66},"2026-02-25","ACTUAL",{"date":68,"type":55},"2026-04-30",{"date":70,"type":55},"2029-10-30",{"name":40,"class":6}]