[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alk-positive-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alk-positive-nsclc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100630732","phase-1-a-phase-12-study-of-tri-611-in-alk-positive-nsclc-100630732",false,"NCT07491497","A Phase 1\u002F2 Study of TRI-611 in ALK-Positive NSCLC","A Phase 1\u002F2, Dose Escalation and Expansion Study of TRI-611, an Oral ALK Molecular Glue Degrader in Participants With Advanced ALK-Positive NSCLC","Inclusion Criteria:\n\n* Pathologically confirmed diagnosis of ALK-positive non-small cell lung cancer (NSCLC)\n* Measurable disease per RECIST v1.1\n* Adequate bone marrow reserve and organ function\n* Part 1: prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line\n* Part 2 Cohort M1: prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line, prior treatment with neladalkib is excluded\n* Part 2 Cohort M2: prior treatment with more than 3 ALK TKIs, prior treatment with lorlatinib and neladalkib is required but neither may have been in the first line\n* Part 2 Cohort M3: participants without prior ALK TKI treatment\n\nExclusion Criteria:\n\n* Participant's cancer has any additional driver alterations known to be a mechanism of resistance to ALK TKIs\n* For participants with central nervous system (CNS) metastases or spinal cord compression, they must not be associated with progressive neurological symptoms or require increasing doses of corticosteroids to control the CNS disease\n* Ongoing treatment with another anticancer treatment or investigational agent\n* Known allergy\u002Fhypersensitivity to TRI-611 or any of its ingredients\n* Major surgery within 4 weeks of receiving the first dose of TRI-611","ALL","18 Years",{"count":19,"type":20},160,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this clinical trial is to learn about the safety and recommended dose of TRI-611 when administered to adults with ALK-positive non-small cell lung cancer (NSCLC). The trial will also evaluate the antitumor activity of TRI-611 in adults with ALK-positive NSCLC.\n\nThe study will be conducted in two parts. The first part will examine different doses of TRI-611. The second part will look at how well TRI-611 works on ALK-positive NSCLC when administered to three groups of participants that differ based on what type of prior therapy they have received.\n\nIn this study participants will:\n\n* Take TRI-611 on a continued basis, provided it is well-tolerated, for as long as their disease is not progressing\n* Visit the clinic approximately seven times in the first 3 months and then just once at the start of each 28-day cycle thereafter\n* Keep a diary of each time they take the study medication",[27,28,29],"ALK-positive NSCLC","ALK-Positive Lung Cancer","ALK-positive Non-small Cell Lung Cancer","RECRUITING","2026-06-15",{"date":33,"type":34},"2026-06-16","ACTUAL",{"date":36,"type":34},"2026-03-11",{"date":38,"type":20},"2034-01-30",{"name":40,"class":41},"TRIANA Biomedicines, Inc.","INDUSTRY",9,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100585606","resistance-mechanisms-and-sequential-treatment-strategies-following-first-line-lorlatinib-in-alk-positive-nsclc-100585606","NCT06904547","Resistance Mechanisms and Sequential Treatment Strategies Following First-Line Lorlatinib in ALK-Positive NSCLC","Resistance Mechanisms and Sequential Treatment Strategies Following First-Line Lorlatinib in ALK-Positive NSCLC: A Multi-center, Observational, Prospective Real-world Cohort Study (LORES)","Inclusion Criteria\n\n1. Age: Patients aged 18 years or older;\n2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC\n3. Documened ALK resrrangemen by approved test (eg.. FisH,IHC. .r NGS).\n4. first-line loelaninab treatment fom Apr2023-Apr-2027.\n5. Evidenoe of popression to first-line lorlztinib within 2 weekes.\n\nExclusion Criteria\n\n1. Previous treatment with other ALK-TKIs: Patients who have previously received any ALK TKI other than lorlatinib;\n2. Concomitant medications: Patients who have received any systemic anti-tumor treatment other than lorlatinib before enrollment.",{"count":51,"type":20},100,"OBSERVATIONAL","This is a prospective, multicenter, non-interventional, single-arm, real-world study planned to be conducted in China, aimed at exploring the resistance mechanisms of first-line lorlatinib treatment in patients with ALK-positive locally advanced or metastatic NSCLC, as well as the efficacy and safety of sequential treatments following lorlatinib resistance in the real-world setting.",[55],"ALK-Positive NSCLC","NOT_YET_RECRUITING","2025-04-08",{"date":59,"type":34},"2025-04-11",{"date":61,"type":20},"2025-04-20",{"date":63,"type":20},"2030-12-31",{"name":65,"class":66},"Shanghai Chest Hospital","OTHER"]