[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590696":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":41,"locations":40,"responsibleParty":47,"collaborators":40,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":40,"enrollmentInfo":59,"targetDuration":40,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":75,"whyStopped":40,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":40},{"fullName":5,"class":6},"Avistone Biotechnology Co., Ltd.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Vebreltinib 150mg BID plus PLB1004 80mg QD","EXPERIMENTAL","Subjects will receive Vebreltinib 150mg orally twice per day (BID) plus PLB1004 80mg orally once per day (QD),21day cycles until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.",[13,14],"Drug: Vebreltinib","Drug: PLB1004",{"label":16,"type":17,"description":18,"interventionNames":19},"Pemetrexed plus cisplatin\u002Fcarboplatin","ACTIVE_COMPARATOR","Subjects randomized to the control group will receive pemetrexed 500 mg\u002Fm² + platinum-based chemotherapy (carboplatin AUC 5 or cisplatin 75 mg\u002Fm²) via intravenous infusion for 4-6 cycles (determined by the investigator) as initial therapy, followed by pemetrexed maintenance therapy (500 mg\u002Fm²) until disease progression, intolerable toxicity, initiation of new antitumor therapy, death, loss to follow-up, or other treatment-terminating conditions (whichever occurred first)",[20],"Drug: Pemetrexed plus Carboplatin or Cisplatin",[22,30,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Vebreltinib","Subjects will receive Vebreltinib Enteric-coated Capsule orally twice per day (BID).",[9],[28,29],"Bozitinib","PLB1001",{"type":23,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"PLB1004","Subjects will receive PLB1004 80mg orally once per day (QD).",[9],[35],"Andamertinib",{"type":23,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Pemetrexed plus Carboplatin or Cisplatin","Subjects randomized to the control group received pemetrexed 500 mg\u002Fm² + platinum-based chemotherapy (carboplatin AUC 5 or cisplatin 75 mg\u002Fm²) via intravenous infusion for 4-6 cycles (determined by the investigator) as initial therapy, followed by pemetrexed maintenance therapy (500 mg\u002Fm²) until disease progression, intolerable toxicity, initiation of new antitumor therapy, death, loss to follow-up, or other treatment-terminating conditions (whichever occurred first).",[16],null,[42],{"name":43,"role":44,"phone":45,"phoneExt":40,"email":46},"Liang Lin","CONTACT","+86-10-84148931","linliang@avistonebio.com",{"type":48,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100590696","phase-3-vebreltinib-plus-plb1004-versus-platinum-based-doublet-chemotherapy-in-patients-with-egfrm-met-locally-advanced-or-metastatic-nsclc-following-egfr-tki-failure-100590696",false,"NCT06970782","Vebreltinib Plus PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFRm, MET+, Locally Advanced or Metastatic NSCLC Following EGFR-TKI Failure","A Randomized, Controlled, Open Label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and\u002For Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure","KYLIN-3","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. At least one measurable lesion as defined by RECIST V1.1.\n5. 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. Before randomization, patients did not recover from any toxicity and\u002F or complications of previous chemotherapy, surgery, radiotherapy and other anti-cancer treatments, that is, did not fall to grade 1 or lower (National Cancer Research Common Toxicity Criteria for Adverse Events \\[NCI-CTCAE\\] v5.0), except for hair loss and irrecoverable permanent radiation damage.\n4. Major surgery or had significant traumatic injury within 4 weeks prior to the first dose of the investigational product.\n5. Pregnant or nursing women.","ALL","18 Years",{"count":60,"type":61},278,"ESTIMATED","INTERVENTIONAL",[64],"PHASE3","Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and\u002For Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure",[67],"Non-Small-Cell Lung Cancer",[69,70,71,72,73,74],"NSCLC","Lung Cancer","MET Amplification","EGFR L858R","EGFR Exon 19 Deletion","EGFR","NOT_YET_RECRUITING","2025-05-20",{"date":78,"type":79},"2025-05-21","ACTUAL",{"date":81,"type":61},"2025-05-15",{"date":83,"type":61},"2028-12-31",{"name":5,"class":6}]