[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Se-Hoon Lee\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100579930","phase-2-clinical-trial-for-safety-and-effectiveness-evaluation-of-tarlatamab-amg757-with-etoposide-carboplatin-and-atezolizumab-in-transformed-small-cell-lung-cancer-patients-from-adenocarcinoma-after-egfr-tki-treatment-100579930",false,"NCT06830694","Clinical Trial for Safety and Effectiveness Evaluation of Tarlatamab (AMG757) With Etoposide, Carboplatin and Atezolizumab in Transformed Small Cell Lung Cancer Patients From Adenocarcinoma After EGFR TKI Treatment","Clinical Trial for Safety and Effectiveness Evaluation of Tarlatamab (AMG757) With Etoposide, Carboplatin and Atezolizumab in Transformed Small Cell Lung Cancer Patients From Adenocarcinoma After EGFR TKI Treatment: Phase II Multicenter Clinical Trial","Inclusion Criteria:\n\n1. Histologically confirmed SCLC and no prior systemic treatment for SCLC\n2. Patient initially diagnosed with activating EGFR mutation (L858R, Del 19) and treated with any kind of EGFR TKI.\n3. Confirmed SCLC transformation right after EGFR TKI treatment failure.\n4. Age ≥19 years\n5. ECOG performance status of 0 to 1\n6. Had at least one measurable lesion.\n7. Adequate organ function\n\n   * Absolute neutrophil count ≥ 1.5 x 109\u002FL\n   * Platelet count ≥ 100 x 109\u002FL\n   * Hemoglobin ≥ 9 g\u002FdL\n   * Estimated glomerular filtration rate based on Modification of Diet in Renal Disease calculation \\> 30 mL\u002Fmin\u002F1.73 m2\n   * Aspartate aminotransferase and alanine aminotransferase ≤ 3 x upper limit of normal (ULN) (or ≤ 5 x ULN for subjects with liver involvement)\n   * Total bilirubin ≤ 1.5 x ULN (or ≤ 2 x ULN for subjects with liver metastases)\n   * Prothrombin time (PT)\u002Finternational normalized ratio and partial thromboplastin time or activated partial thromboplastin time ≤ 1.5 x institutional ULN Note: Subjects on stable anticoagulation therapy are allowed.\n8. Pulmonary function: No clinically significant pleural effusion at the timepoint of screening. Pleural effusion with no significant symptom is allowed for enrollment.\n9. Cardiac function: Cardiac ejection fraction ≥ 50%\n10. Female subjects must either be of non-reproductive potential\n11. Female subject with reproductive potential can be enrolled with agreement to following guidance.\n\n    * subject uses contraception during treatment and through 60 days after receiving last dose of tarlatamab or for 6 months after last dose of carboplatin and\u002For etoposide and 5 months after last dose of atezolizumab.\n12. Subject is willing and able to comply with the protocol\n13. Signed written informed consent\n\nExclusion Criteria:\n\n1. Treated with additional chemotherapy after confirmed with transformed SCLC.\n2. Previously exposed to the immune checkpoint inhibitor treatment.\n3. Untreated symptomatic brain metastases or leptomeningeal disease.\n\n   * Asymptomatic brain metastases can be enrolled per investigator decision\n4. Uncontrolled systemic illness including uncontrolled hypertension, active bleeding, or active infection.\n5. Past medical history of interstitial lung disease, drug induced interstitial lung disease, radiation pneumonitis which required steroid treatment, active non- infectious pneumonitis\n6. Active or prior documented autoimmune or inflammatory disorders\n7. Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\> class II) within 6 months prior to first dose of study treatment\n8. History of solid organ transplant.\n9. Major surgical procedures within 28 days prior to first dose of study treatment.\n10. History of allergic reactions or acute hypersensitivity reactions to antibody therapies, platinum chemotherapy, or etoposide.\n11. Disagree to the guidance of contraception during the study.","ALL","19 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The primary treatment option for non-small cell lung cancer (NSCLC) adenocarcinoma (ADC) with activating epidermal growth factor receptor (EGFR) mutation is EGFR tyrosine kinase inhibitor (TKI). After a certain period of treatment with EGFR TKI, acquired resistance emerges most frequently with a secondary mutation, p.T790M (36-50%), followed by MET amplification (10-19%). Interestingly, up to 3-5% of patients experience histological transformation into small cell lung cancer (SCLC).\n\nAs an underlying mechanism, ADC with a predisposed clonally inactivated Rb and p53 mutation and APOBEC mutation signature is known to be associated with SCLC transformation. The transformed SCLC harbors similar morphological and immunohistochemical (IHC) characteristics as those observed in de novo SCLC, including high expression of chromogranin and synaptophysin. However, little is known about the clinical outcomes of transformed SCLC, with limited studies arguing that their outcomes are similar to those of de novo SCLC, where the median overall survival is approximately 9 to 10 months after the transformation.\n\nAs the first line treatment of SCLC, atezolizumab or durvalumab with four cycles of conventional chemotherapy followed by maintenance therapy demonstrated prolonged overall survival (OS) and placed as the standard treatment option. However, median progression-free survival (PFS) of both study was only 5.2 months and 5.1 months, despite the objective response rate showing 60.2% and 79%. This finding suggest further development of maintenance treatment strategy to prolonged longer duration of response to the treatment.\n\nIn addition to the conventional treatment, Tarlatamab (AMG757), bispecific t-cell engager (BiTE), designed to engage DLL3 on SCLC and CD3 on T-cell has been tested in SCLC. DLL3 is expressed in more than 80% of patients with SCLC, regardless of disease stage and researched for the potential target protein for the antibody based treatment in SCLC. By targeting DLL3 using Tarlatamab, engagement of tumor antigen and CD3 lead to cytotoxic synapse formation, triggering the release of proinflammatory cytokines, perforin, and granzymes from activated T-cells, potentially resulting apoptosis. The first clinical outcome of Tarlatamab was reported from the DeLLphi-300 study, phase 1 dose exploration study, showing confirmed partial response in 23% of the heavily treated SCLC and 37% of the patients showed decrease in tumor burden. Median duration of response was 13.0 months (95% confidential interval CI: 6.2 - 14.9 months), median PFS of 3.7 months and median OS was 13.2 months. In the treatment naïve SCLC, DeLLphi-303 study, phase 1b study combining tarlatamab + PD-L1 inhibitor + carboplatin and etoposide, is ongoing to evaluate the clinical efficacy in the front line setting which include only histologically confirmed extensive disease SCLC population (NCT05361395).\n\nBased on previous clinical and pre-clinical outcomes, showing similar disease characteristics between transformed SCLC from the adenocarcinoma who treated with EGFR TKI with de novo SCLC, this study is designed to evaluate the clinical efficacy of tarlatamab with currently standard treatment in transformed SCLC.",[26],"Small Cell Carcinoma of Lung","RECRUITING","2026-02-19",{"date":30,"type":31},"2026-02-23","ACTUAL",{"date":33,"type":31},"2025-05-13",{"date":35,"type":20},"2027-06-30",{"name":37,"class":38},"Se-Hoon Lee","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100626234","phase-2-fecal-microbiota-transplantfmt-combination-with-tislelizumab-in-advanced-or-metastatic-nsclc-100626234","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,{"count":50,"type":20},15,[23],"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.",[54],"Non Small Cell Lung Cancer","NOT_YET_RECRUITING","2026-02-18",{"date":58,"type":31},"2026-02-25",{"date":60,"type":20},"2026-04-30",{"date":62,"type":20},"2029-10-30",{"name":37,"class":38},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":71,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":5},"100330126","genomic-analysis-to-identify-a-predictive-biomarker-for-immunotherapy-100330126","NCT03578185","Genomic Analysis to Identify a Predictive Biomarker for Immunotherapy","LC_Biomarker","Inclusion Criteria:\n\n1. aged above or equal to 18\n2. Histologically confirmed lung cancer patients\n3. Patient treated with immune checkpoint inhibitor\n\nExculsion Criteria:\n\nNA","18 Years",{"count":73,"type":20},800,"OBSERVATIONAL","This study is designed to identify the predictive biomarker for immunotherapy using patient samples (tumor tissue, blood, fecal material) who treated with immune checkpoint inhibitor.",[77],"Lung Cancer","2024-11-29",{"date":80,"type":31},"2024-12-03",{"date":82,"type":31},"2018-04-11",{"date":84,"type":20},"2025-12-31",{"name":37,"class":38},""]