[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542453":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":40,"centralContacts":41,"locations":47,"responsibleParty":67,"collaborators":40,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":40,"enrollmentInfo":79,"targetDuration":40,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":50,"whyStopped":40,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Avistone Biotechnology Co., Ltd.","INDUSTRY",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase Ib:Vebreltinib 100mg\u002F150mg\u002F200mg BID + PLB1004 80mg\u002F160mg QD","EXPERIMENTAL","In the dose-escalation and dose-expansion phase, patients received oral Vebreltinib 100mg\u002F150mg\u002F200mg BID plus PLB1004 80mg\u002F160mg once daily.",[13,14],"Drug: Vebreltinib","Drug: PLB1004",{"label":16,"type":10,"description":17,"interventionNames":18},"Phase II:Cohort 1","In phase II-Cohort 1:Failed first-generation or second-generation EGFR inhibitors, negative T790M mutation and c-Met amplification(GCN≥6).Patients received oral Vebreltinib（RP2D）plus PLB1004 （RP2D）.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Phase II:Cohort 2","In phase II-Cohort 2 :Failed third-generation EGFR inhibitors, c-Met amplification(GCN≥6).Patients received oral Vebreltinib（RP2D）plus PLB1004 （RP2D）.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Phase II:Cohort 3","In phase II-Cohort 3 :Failed first-generation or second-generation EGFR inhibitors, c-Met over expression.Patients received oral Vebreltinib（RP2D）plus PLB1004 （RP2D）.",[13,14],[28,36],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Vebreltinib","Phase Ib is a dose escalation study, the initial dose of Vebreltinib is 100mg\u002F150mg\u002F200mg,according to the result of Phase Ib, will confirm the RP2D.",[16,20,24,9],[34,35],"Bozitinib","PLB1001",{"type":29,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"PLB1004","Phase Ib is a dose escalation study, the initial dose of PLB1004 is 80mg\u002F160mg,according to the result of Phase Ib, will confirm the RP2D.",[16,20,24,9],null,[42],{"name":43,"role":44,"phone":45,"phoneExt":40,"email":46},"Liang Lin","CONTACT","+86-10-84148931","linliang@avistonebio.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Shanghai Pulmonary Hospital","RECRUITING","Shanghai","Shanghai Municipality","200433","China","CN",{"type":57,"coordinates":58},"Point",[59,60],121.45806,31.22222,{"lat":60,"lon":59},[63],{"name":64,"role":44,"phone":65,"phoneExt":40,"email":66},"Caichun Zhou, PHD","+86-21-65115006","caicunzhoudr@163.com",{"type":68,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100542453","phase-1-vebreltinib-plus-plb1004-in-egfr-mutated-advanced-nsclc-with-met-amplification-or-met-overexpression-following-egfr-tki-100542453",false,"NCT06343064","Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI","A Phase Ib\u002FII Study of Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI","KYLIN-1","Inclusion Criteria:\n\n1. Ability to understand and willingness to sign a written informed consent document.\n2. Aged at least 18 years old.\n3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\\~IV).\n4. EGFR mutations, including exon 19 deletion and exon 21 L858R.\n5. C-Met overexpression and\u002For c-Met amplification confirmed after treatment with EGFR-TKI.\n6. At least one measurable lesion as defined by RECIST V1.1.\n7. ECOG performance status 0 to 1.\n\nExclusion Criteria:\n\n1. Previous treatment with MET inhibitors or HGF-targeted therapy.\n2. There are mutations of ALK or ROS1.\n3. Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control.\n4. Pregnant or nursing women.","ALL","18 Years",{"count":80,"type":81},156,"ESTIMATED","INTERVENTIONAL",[84,85],"PHASE1","PHASE2","Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC",[88],"Non-Small-Cell Lung Cancer",[88,90,91,92,93,94],"EGFR","NSCLC","Lung Cancer","MET Amplified","MET Expression","2025-05-20",{"date":97,"type":98},"2025-05-21","ACTUAL",{"date":100,"type":98},"2023-06-13",{"date":102,"type":81},"2026-12-31",{"name":5,"class":6},1]