[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621999":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":33,"studyPopulation":11,"armGroups":34,"interventions":41,"overallOfficials":11,"centralContacts":47,"locations":11,"responsibleParty":53,"collaborators":57,"id":62,"slug":11,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":77,"conditions":78,"keywords":11,"overallStatus":80,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":11},{"fullName":5,"class":6},"The First Affiliated Hospital of Guangzhou Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Progression Free Survival (PFS) by investigator assessment",null,"Until progression, assessed up to approximately 2 years",[14,17,20,22,24],{"measure":15,"description":11,"timeFrame":16},"Objective Response Rate （ORR）","Two years after the last subject was enrolled in the group",{"measure":18,"description":11,"timeFrame":19},"Overall Survival (OS)","Until death, assessed up to approximately 3 years",{"measure":21,"description":11,"timeFrame":16},"Disease Control Rate (DCR)",{"measure":23,"description":11,"timeFrame":16},"Duration of Response (DOR)",{"measure":25,"description":11,"timeFrame":26},"AE","until to 90 days after the last dose，assessed up to approximately 3 years",{"allocation":28,"interventionModel":29,"interventionModelDescription":11,"primaryPurpose":30,"observationalModel":11,"timePerspective":11,"maskingInfo":31},"NA","SINGLE_GROUP","TREATMENT",{"masking":32,"maskingDescription":11,"whoMasked":11},"NONE","Patients who meet the following criteria are enrolled:\n\nAged 18-75 years Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) (AJCC 9th edition) Pathologically documented HER2 mutation, amplification, or overexpression Received ≥1 prior line of systemic anti-cancer therapy for advanced\u002Fmetastatic disease Received SHR-A1811 combined with pertuzumab",[35],{"label":36,"type":37,"description":38,"interventionNames":39},"SHR-A1811 combined with pertuzumab","EXPERIMENTAL","Intravenous infusion，Q3 week, SHR-A1811 combined with pertuzumab",[40],"Drug: SHR-A1811",[42],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":11},"DRUG","SHR-A1811","Intravenous infusion, q3 week, SHR-A1811 combined with pertuzumab",[36],[48],{"name":49,"role":50,"phone":51,"phoneExt":11,"email":52},"Wenhua Liang","CONTACT","13710249454","550627660@qq.com",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Jianxing He","Guangzhou Medical University Affiliated First Hospital National Respiratory Research Center",[58,60],{"name":59,"class":6},"Maoming People's Hospital",{"name":61,"class":6},"Peking University Shenzhen Hospital","100621999",false,"NCT07377916","Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced NSCLC","A Prospective, Single-Arm, Exploratory Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced Non-Small Cell Lung Cancer","NSCLC","Inclusion Criteria:\n\n* Aged 18-75 years\n* Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) (AJCC 9th edition)\n* Pathologically documented HER2 mutation, amplification, or overexpression\n* Received ≥1 prior line of systemic anti-cancer therapy for advanced\u002Fmetastatic disease\n* There is at least one measurable lesion according to RECIST V1.1 criteria\n* ECOG score of 0 or 1.\n* The expected survival is ≥12 weeks\n\nExclusion Criteria:\n\n* There are untreated or active central nervous system (CNS) tumor metastases\n* Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.\n* Pleural, ascites, or pericardial effusion requiring intervention occurred within 14 days prior to initial administration\n* Systemic antitumor therapy was performed 4 weeks prior to study initiation\n* Subjects who have previously received HER2-targeted therapy (excluding pan-HER tyrosine kinase inhibitors) or antibody-drug conjugates with a topoisomerase I inhibitor payload.\n* Use of strong CYP3A4, CYP2D6, P-gp, or BCRP inhibitors or inducers within less than 5 drug half-lives prior to the first dose.\n* Has active infection requiring systemic treatment.","ALL","18 Years","75 Years",{"count":73,"type":74},60,"ESTIMATED","INTERVENTIONAL",[28],"The study enrolled patients with advanced or metastatic NSCLC harboring HER2 mutations, amplification, or overexpression who had progressed after ≥1 prior lines of anticancer therapy. After enrollment, participants received treatment with rezetamab plus pertuzumab until disease progression, intolerable toxicity, withdrawal of consent, or other conditions requiring treatment discontinuation.",[79],"Non-Small Cell Lung Cancer","NOT_YET_RECRUITING","2026-01-28",{"date":83,"type":84},"2026-01-30","ACTUAL",{"date":86,"type":74},"2026-02-15",{"date":88,"type":74},"2029-12-31",{"name":5,"class":6}]