[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621999":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":31,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":20,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":20,"overallStatus":56,"whyStopped":20,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":20},{"fullName":5,"class":6},"The First Affiliated Hospital of Guangzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-A1811 combined with pertuzumab","EXPERIMENTAL","Intravenous infusion，Q3 week, SHR-A1811 combined with pertuzumab",[13],"Drug: SHR-A1811",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","SHR-A1811","Intravenous infusion, q3 week, SHR-A1811 combined with pertuzumab",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Wenhua Liang","CONTACT","13710249454","550627660@qq.com",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Jianxing He","Guangzhou Medical University Affiliated First Hospital National Respiratory Research Center",[32,34],{"name":33,"class":6},"Maoming People's Hospital",{"name":35,"class":6},"Peking University Shenzhen Hospital","100621999","clinical-study-of-shr-a1811-combined-with-pertuzumab-as-second-line-therapy-in-patients-with-her2-altered-advanced-nsclc-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":48,"type":49},60,"ESTIMATED","INTERVENTIONAL",[52],"NA","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.",[55],"Non-Small Cell Lung Cancer","NOT_YET_RECRUITING","2026-01-28",{"date":59,"type":60},"2026-01-30","ACTUAL",{"date":62,"type":49},"2026-02-15",{"date":64,"type":49},"2029-12-31",{"name":5,"class":6}]