[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alk-positive-advanced-nsclc-patients\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alk-positive-advanced-nsclc-patients":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":5},"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"]