[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sehhoon Park\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,59],{"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","2026-09-07",{"date":30,"type":31},"2026-09-10","ACTUAL",{"date":33,"type":31},"2025-05-13",{"date":35,"type":20},"2027-06-30",{"name":37,"class":38},"Sehhoon Park","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":53,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":39},"100524290","phase-2-lazertinib--tepotinib-for-egfr-mutant-nsclc-in-met-overexpressed-or-amplified-who-progressed-after-lazertinib-treatment-100524290","NCT06106802","Lazertinib & Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment","Lazertinib and Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment: A Phase II Multi-center Trial","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer which is not amenable to treatment with a curative aim (e.g., surgery or radiation)\n2. Confirmed EGFR mutations (exon 19 deletion, L858R) with acquired resistance after first-line lazertinib treatment (either partial response, complete response or stable disease last more than 6 months after initiation of Lazertinib) - patient can maintain the treatment with prior EGFR treatment as beyond progression until the patient start the treatment per this protocol\n3. First-line cytotoxic chemotherapy received as palliative treatment is acceptable after the failure of Lazertinib (Patients with disease progression after adjuvant or neoadjuvant chemotherapy within 6 months are eligible to participate)\n4. Patient with MET amplification FISH GCN ≥5 and\u002For MET\u002FCEP7 ≥ 2 (If additional resistance mechanism to lazertinib, such as C797S, is observed with MET amplification, the recruitment needs to be discussed in advance with the principal investigator)\n5. Available tissue for MET FISH\n6. Age of 19 or more\n7. Performance status of Eastern Cooperative Oncology Group 0 to 2\n8. Expected minimum life expectancy of 12 weeks\n9. Adequate organ function\n\n   1. Absolute neutrophil count (ANC) ≥1500cells\u002Fmm3\n   2. Platelet count ≥100,000cells\u002Fmm3\n   3. Total bilirubin ≤1.5 x upper limit of normal(ULN)\n   4. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN (or ≤5.0 x ULN, if liver metastasis is present)\n   5. Creatinine level ≤1.5 x upper limit of normal (ULN) or creatinine clearance ≥ 45mL\u002Fmin (Calculated with Cockcroft- Gault equation)\n10. Available to provide the adequate tissue and blood for the genomic tests\n\n    \\- At least 20 unstained slide and 20 cc of blood at baseline and disease progression (If not, participant must be confirmed by the principal investigator\n11. Agreed to perform re-biopsy at the timepoint of disease progression\n12. Female subjects must either be of non-reproductive potential\n13. Subject willing and able to comply with the protocol\n14. Signed written informed consent\n\nExclusion Criteria:\n\n1. Previously treatment with any kind of EGFR TKI other than lazertinib\n2. All concurrent and\u002For other active malignant tumors requiring systemic therapy within 2 years prior to the initial administration of the investigational drug (However, the patient may participate if previous malignant tumor has been cured, and no further treatment is required)\n3. Uncontrolled central nervous system metastases\n4. Spinal cord compression, leptomeningeal carcinomatosis\n5. Uncontrolled systemic illness, including uncontrolled hypertension, active bleeding, or active infection\n6. Radiotherapy with a wide field of radiation within 2 weeks or radiotherapy with a limited field of radiation (localized radiotherapy or gamma knife surgery) for palliation within 1 week\n7. Any unresolved toxicities from prior therapy, greater than CTCAE grade 1\n8. Prior history of interstitial lung disease (ILD) or ILD like symptoms\n9. Mean QT interval corrected for heart rate (QTc) ≥ 470 ms\n10. No measurable lesion\n11. Unable to swallow the product due to refractory nausea, vomiting or chronic gastrointestinal disease",{"count":48,"type":20},47,[23],"As the 3rd generation, EGFR TKI has become a standard treatment option for the 1st line therapy in EGFR mutated patients, the necessity for evaluating resistant mechanism to determine the matched subsequent therapeutic option has been highlighted. From the 1st line Osimertinib treatment, the heterogenous resistance mechanism has been observed showing most commonly by MET amplification (7-15%) followed by additional on-target EGFR mutation (6-10%), BRAF, PI3KCA, KRAS, HER2 mutation (13-14%) and still 40 to 50% remain unknown for the mechanism. (A. Leonetti et al.British Journal of Cancer(2019))\n\nBased on the observation showing the MET amplification as the most common resistance mechanism to the 3rd generation EGFR TKI treatment, the \"TATTON\" study, a multi-arm, phase IB trial, demonstrated early clinical data of Osimertinib in combined with savolitinib. Among the patients, c-MET amplified patients who were previously treated with 3rd generation EGFR TKI, a combination of Osimertinib and savolitinib, showed an objective response rate of 33% and median PFS of 5.5 months. (G. Oxnard et al. Annals of Oncology(2020))\n\nThe clinical efficacy of Osimertinib with savolitinib in MET overexpressed or amplification patients are reported from the global phase II, \"SAVANNAH\" study. The preliminary results from the SAVANNAH trial showed that Osimertinib plus savolitinib demonstrated an objective response rate of 49% in patients with a high level of MET overexpression and\u002For amplification, defined as IHC90+ and\u002For FISH 10+, whose disease progressed on treatment with Osimertinib. The highest ORR was observed in patients with a high level of MET who were not treated with prior chemotherapy (52%). In patients whose tumors did not show a high level of MET, the ORR was 9% (MJ Ahn, WCLC, 2022). There are ongoing global Phase III SAFFRON study to validate the outcome from SAVANNAH study.\n\nIt has been reported that around 62% of tumor in Osimertinib progressed sample has MET overexpression and\u002For amplification, and more than one-third (34%) met the defined high MET level cut-off.\n\nAs Lazertinib is about to be approved as the treatment option for the treatment naïve EGFR mutated NSCLC, it is also becoming important to develop a further treatment plan based on the MET amplification status. In this study, the investigators designed a phase II study based on the MET amplification status to evaluate the clinical efficacy of Lazertinib + tepotinib.",[52],"Non-Small Cell Lung Cancer Metastatic",{"date":30,"type":31},{"date":55,"type":31},"2024-06-11",{"date":57,"type":20},"2029-09-30",{"name":37,"class":38},{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":66,"maxAge":4,"enrollmentInfo":67,"targetDuration":69,"studyType":70,"phases":4,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":39},"100511287","developing-artificial-intelligence-based-algorism-to-predict-side-effects-and-symptoms-from-chemotherapy-100511287","NCT05937477","Developing Artificial Intelligence-based Algorism to Predict Side Effects and Symptoms From Chemotherapy","Developing Artificial Intelligence-based Algorism Based on Life-log Data Acquired From Wearable Device for the Prediction of Chemotherapy-induced Side Effects and Symptom","Inclusion Criteria:\n\n* 20 years of age or older\n* Must have diagnosed with lung, head and neck, or esophageal cancer,\n\n  1. scheduled to receive their first treatment in preoperative or postoperative chemotherapy.\n  2. scheduled for systemic chemotherapy due to recurrence or metastasis.\n* Eastern Cooperative Oncology (ECOG) performance status of 0 to 2.\n* Patients who have access to a smartphone and can use the mobile app on their own.\n* Understand the purpose of the study and agree to participate in the study.\n\nExclusion Criteria:\n\n* Patients who, in the judgment of the researcher, have difficulty using the application.\n* Patients who are judged by the medical staff to be unable to participate in the study.","20 Years",{"count":68,"type":20},500,"12 Months","OBSERVATIONAL","In this study, the investigators obtain wearable disease based biomarkers from patients diagnosed with cancer and undergoing chemotherapy, and simultaneously measure patient self-reported adverse events through an app to evaluate chemotherapy completion rates, emergency room visits, and frequency of CTCAE adverse events.\n\nThe investigators will develop an artificial intelligence-based algorism that can predict patients' side effects based on biomarkers alone.",[73,74,75],"Lung Cancer","Head and Neck Cancer","Esophageal Cancer","2023-07-20",{"date":78,"type":31},"2023-07-21",{"date":80,"type":31},"2023-06-08",{"date":82,"type":20},"2026-06-30",{"name":37,"class":38},""]