[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530332":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":36,"centralContacts":41,"locations":36,"responsibleParty":47,"collaborators":36,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":36,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":36,"enrollmentInfo":60,"targetDuration":36,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":36,"overallStatus":71,"whyStopped":36,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":36},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm1: Treatment Naive NSCLC","EXPERIMENTAL","RC48+third-generation EGFR TKIs in treatment-naive patients harboring EGFR mutation and HER2 alterations",[13,14],"Drug: Disitamab Vedotin","Drug: third-generation EGFR TKIs (Almonertinib\u002FFurmonertinib\u002FOsimertinib)",{"label":16,"type":10,"description":17,"interventionNames":18},"Arm2: Locally Progressed","This cohort includes ERBB2 altered patients after third-generation EGFR-TKIs treatment with locally or slowly progressed disease, who may continue to benefit from third-generation EGFR-TKIs treatment under investigators' evaluation.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Arm3: Extensively Progressed","This cohort includes ERBB2 altered patients after third-generation EGFR-TKIs treatment with extensively progressed disease, who may be less likely to benefit from third-generation EGFR-TKIs treatment under investigators' evaluation.",[13,23],"Drug: pyrotinib",[25,32,37],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Disitamab Vedotin","RC48+third-generation EGFR TKIs (Almonertinib\u002FFurmonertinib\u002FOsimertinib) in treatment naive NSCLC",[9,16,20],[31],"RC48",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"third-generation EGFR TKIs (Almonertinib\u002FFurmonertinib\u002FOsimertinib)","RC48+third-generation EGFR TKIs (Almonertinib\u002FFurmonertinib\u002FOsimertinib) after EGFR-TKIs progression",[9,16],null,{"type":26,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"pyrotinib","RC48+pyrotinib after EGFR-TKIs progression",[20],[42],{"name":43,"role":44,"phone":45,"phoneExt":36,"email":46},"Jie Wang, Dr","CONTACT","010-87788219","zlhuxi@163.com",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Jie Wang","Head of Oncology Department","100530332","phase-2-rc48-combined-with-egfr-or-her2-tki-for-locally-advanced-or-metastatic-nsclc-patients-with-her2-alterations-100530332",false,"NCT06185400","RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations","Disitamab Vedotin（RC48）Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations","Inclusion Criteria:\n\n1. Age: 18 (inclusive) or above, regardless of gender.\n2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC, not suitable for radical surgery or radiotherapy (TNM 8th Edition).\".\n3. HER2 alterations include HER2 gene mutations, gene amplification and HER2 protein over-expression;\n4. Number of treatment lines:\n\n   * Arm1: patients who have not previously received systemic treatment for advanced diseases;\n   * Arm2: Previously received first line of third-generation EGFR-TKIs treatment with local progression, oligometastasis, or slow progression, and evaluated by the researchers to continue to benefit from third-generation EGFR-TKIs treatment;\n   * Arm3: Previously received first line of third-generation EGFR-TKIs treatment with extensively progression, and evaluated by the researchers not likely to continue to benefit from third-generation EGFR-TKIs treatment;\n5. There is at least one measurable lesion that meets the definition of the RECIST 1.1 standard at baseline.\n6. ECOG fitness status score: 0 or 1 point.\n\nExclusion Criteria:\n\n1. Central nervous system metastasis or meningeal metastasis with clinical symptoms.\n2. Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.\n3. Have a history of severe cardiovascular disease.\n4. Have a history of interstitial lung disease or drug-induced interstitial lung disease requiring steroids treatment; radiation pneumonia.\n5. Have a history of neurological disorders or mental illnesses, including epilepsy or dementia.\n6. Pregnant or lactating women.\n7. The researcher believes that the subject is not suitable to participate in this clinical study due to other reasons.","ALL","18 Years",{"count":61,"type":62},108,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","Disitamab Vedotin（RC48）combined with EGFR or HER2 TKIs in locally advanced or metastatic NSCLC Patients with HER2 Alterations.",[68,69,70,27],"Non Small Cell Lung Cancer","ERBB2 Mutation-Related Tumors","ERBB2 Gene Duplication","NOT_YET_RECRUITING","2023-12-28",{"date":74,"type":75},"2023-12-29","ACTUAL",{"date":77,"type":62},"2024-02-01",{"date":79,"type":62},"2026-12-01",{"name":5,"class":6}]