[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-resistance\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-resistance":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100596450","primary-resistance-mechanisms-of-alk-tkis-100596450",false,"NCT07045610","Primary Resistance Mechanisms of ALK TKIs","Explore the Primary Resistance Mechanisms of Anaplastic Lymphoma Kinase Inhibitors","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Histologically or cytologically diagnosed NSCLC\n3. ALK gene fusion detected at initial diagnosis of NSCLC\n4. Patients exhibiting primary resistance to ALK-TKI therapy, defined as the absence of initial response or progression within 3 to 6 months of treatment initiation, were included.\n5. Able and willing to provide written informed consent prior to performing any study related procedures and to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Unable to provide written inform consent\n2. The patients had received other systemic treatments except ALK TKI.\n3. Unable to undergo tumor biopsy or venipuncture","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","OBSERVATIONAL","Anaplastic lymphoma kinase (ALK) gene rearrangement is a known oncogenic driver in non-small cell lung cancer (NSCLC). ALK tyrosine kinase inhibitors (TKIs) have been clearly shown to produce excellent therapeutic effects and prolong survival in patients with this gene mutation. According to current treatment guidelines, ALK inhibitors are the first-line treatment of choice for ALK-positive advanced NSCLC patients. However, although ALK TKIs are very effective, there is still a small group of patients who do not achieve good treatment outcomes, developing resistance and tumor progression within 3 to 6 months of initial ALK TKI use. This is called primary resistance. Intrinsic resistance to ALK inhibition occurs when the best clinical response after first-generation and second\u002Fthird-generation TKI treatment is disease progression. Approximately 5-7% of cases after crizotinib treatment, 9% after ceritinib treatment, and 25% after lorlatinib treatment show no response to treatment, and no specific ALK mutation has been found to explain the occurrence of primary resistance. Currently, many different resistance mechanisms are known, some of which are still ALK-related, while others are ALK-independent alternative survival pathways. However, most research focuses on acquired resistance, with very few studies on primary resistance, only a few case reports. Therefore, this study aims to explore the primary ALK TKI resistance mechanisms.\n\nThe investigators plan to explore the incidence and mechanisms of primary ALK TKI resistance in ALK-positive advanced NSCLC patients who develop primary resistance or rapid progression (within 3-6 months) during ALK inhibitor treatment by re-obtaining tumor samples for genetic analysis.",[24,25,26],"ALK-positive Advanced NSCLC Patients","Primary Resistance","NGS",[28,29,30,31,32,33],"lung cancer","Anaplastic lymphoma kinase (ALK) gene rearrangement","gene mutation","Primary resistance","Next-generation sequencing","Target therapy","NOT_YET_RECRUITING","2025-06-22",{"date":37,"type":38},"2025-07-01","ACTUAL",{"date":37,"type":20},{"date":41,"type":20},"2028-07-01",{"name":43,"class":44},"National Taiwan University Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":21,"phases":4,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":45},"100485242","exploring-the-mechanism-of-primary-resistance-to-third-generation-egfr-tkis-as-first-line-treatment-in-egfr-positive-advanced-nsclc-precise-study-100485242","NCT05598528","Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)","A Multicenter Clinical Study to Explore the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)","PRECISE","Inclusion Criteria:\n\n1. Age \\>18 years;\n2. Histological or cytopathological diagnosed NSCLC;\n3. According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is unresectable IIIB-IV or recurrence and metastasis after surgery;\n4. At least one measurable lesion can be evaluated according to the Response Evaluation Criteria In Solid Tumours v1.1 (RECIST1.1) criteria;\n5. Positive EGFR mutation confirmed by tissue or cytology (pleural fluid, cerebrospinal fluid, etc.);\n6. Use of third-generation EGFR-TKIs approved by the NMPA for NSCLC as first-line therapy;\n7. Cooperate with the provision of clinicopathological data, imaging data, sample collection, and follow-up required for the research process, and agree to use the test data for subsequent research and product development;\n8. Agree to participate in this study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form;\n2. Pregnant and lactating women;\n3. Other malignant neoplastic diseases within 3 years;\n4. Patients who have undergone other clinical drug trials;\n5. Received systemic anti-tumor therapy within 2 years;",{"count":55,"type":20},210,"5 Years","Lung cancer is currently the world's largest malignant tumor for cancer-related deaths with non-small cell lung cancer (NSCLC) accounting for 80%-85%. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), especially the 3rd-generation EGFR-TKIs have demonstrated strong antitumor effects in EGFR-positive patients.\n\nHowever, approximately 20% of EGFR-positive were primarily resistant to 3rd generation EGFR-TKIs, i.e., clinical non-response or disease progression in the short term.\n\nThis study aimed to clarify the molecular indicators that predict the benefits of 3-rd EGFR-TKIs as first-line therapy in NSCLCpatients with EGFR-positive. Further, to clarify their primary drug resistance mechanisms, which is of great significance for the treatment and clinical decision-making of NSCLC disease.",[59,60,61,25,62],"Lung Cancer, Non-small Cell","EGFR Gene Mutation","EGFR-TKI Resistant Mutation","Circulating Tumor DNA","RECRUITING","2024-11-27",{"date":66,"type":38},"2024-12-02",{"date":68,"type":38},"2021-09-28",{"date":70,"type":20},"2026-12-31",{"name":72,"class":44},"Second Xiangya Hospital of Central South University"]