[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560223":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":36,"studyPopulation":29,"armGroups":37,"interventions":51,"overallOfficials":72,"centralContacts":77,"locations":83,"responsibleParty":102,"collaborators":29,"id":104,"slug":29,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":105,"sex":111,"minAge":112,"maxAge":29,"enrollmentInfo":113,"targetDuration":29,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":85,"whyStopped":29,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Avistone Biotechnology Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"The objective response rate of the tumor (ORR)","The incidence of confirmed complete response or partial response.","2 Years",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"The disease control rate (DCR)","The incidence of complete response, partial response and stable disease.",{"measure":18,"description":19,"timeFrame":12},"Duration of Response (DoR)","The duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recorded.",{"measure":21,"description":22,"timeFrame":12},"Progression-free survival (PFS)","Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).",{"measure":24,"description":25,"timeFrame":12},"Time to Response (TTR)","The period from the date of randomization to the date when the criteria for complete response or partial response was first measured (first record shall prevail).",{"measure":27,"description":28,"timeFrame":12},"Incidence of Treatment-Emergent Adverse Events","Incidence of Treatment-Emergent Adverse Events (TEAEs),A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":29,"whoMasked":29},"NONE","A Multicenter,Randomized,open-label,Phase II Study to Evaluate the Efficacy and Safety of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients with EGFRm+(exon 19 deletion or exon 21 L858R)\u002FMET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.",[38,45],{"label":39,"type":40,"description":41,"interventionNames":42},"Vebreltinib 150mg BID+PLB1004 80mg QD","EXPERIMENTAL","Subjects will receive Vebreltinib 150mg orally twice per day (BID) + PLB1004 80mg orally once per day (QD),21day cycles until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.",[43,44],"Drug: Vebreltinib","Drug: PLB1004",{"label":46,"type":47,"description":48,"interventionNames":49},"Osimertinib 80mg QD","ACTIVE_COMPARATOR","Subjects will receive Osimertinib 80mg orally once per day (QD),21day cycles until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.",[50],"Drug: Osimertinib",[52,60,66],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"DRUG","Vebreltinib","Subjects will receive Vebreltinib orally twice per day (BID).",[39],[58,59],"Bozitinib","PLB1001",{"type":53,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"Osimertinib","Subjects will receive Osimertinib 80mg orally once per day (QD).",[46],[65],"AZD9291",{"type":53,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"PLB1004","Subjects will receive PLB1004 80mg orally once per day (QD).",[39],[71],"Andamertinib",[73],{"name":74,"affiliation":75,"role":76},"Yi long Wu, MD","Guangdong Provincial People's Hospital","PRINCIPAL_INVESTIGATOR",[78],{"name":79,"role":80,"phone":81,"phoneExt":29,"email":82},"Liang Lin","CONTACT","08-10-84148931","linliang@avistonebio.com",[84],{"facility":75,"status":85,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"RECRUITING","Guangzhou","Guangdong","510080","China","CN",{"type":92,"coordinates":93},"Point",[94,95],113.25,23.11667,{"lat":95,"lon":94},[98],{"name":99,"role":80,"phone":100,"phoneExt":29,"email":101},"Jinji Yang, MD","+86-20-83827812","yangjinji@gdph.org.cn",{"type":103,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100560223",false,"NCT06574347","Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+\u002FMET+ Locally Advanced or Metastatic NSCLC.","A Phase II Study of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+\u002FMET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.","KYLIN-2","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. Patients with previously untreated, EGFRm-positive (exon 19 deletion or L858R) and MET overexpression (IHC 3+) .\n5. At least one measurable lesion as defined by RECIST V1.1.\n6. ECOG performance status 0 to 1.\n\nExclusion Criteria:\n\n1. There are mutations of ALK or ROS1.\n2. Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control.\n3. Pregnant or nursing women.","ALL","18 Years",{"count":114,"type":115},120,"ESTIMATED","INTERVENTIONAL",[118],"PHASE2","Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+\u002FMET+ Locally Advanced or Metastatic NSCLC.",[121],"Non-Small-Cell Lung Cancer",[123,124,125,126,127,128],"NSCLC","Lung Cancer","MET Amplification","EGFR L858R","EGFR Exon 19 Deletion","EGFR","2025-05-20",{"date":131,"type":132},"2025-05-21","ACTUAL",{"date":134,"type":132},"2024-08-07",{"date":136,"type":115},"2027-07-31",{"name":5,"class":6},1]