[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637654":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":24,"centralContacts":29,"locations":39,"responsibleParty":57,"collaborators":10,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":10,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Guangzhou Institute of Respiratory Disease","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HER2 Positive OrTROP2 Positive non-small cell lung cancer",null,"The abundance of HER2 or TROP2 target expression was determined by immunohistochemistry and categorized into strongly positive and weakly positive groups, representing the experimental group and negative control group, respectively. Using an immunococulture system based on patient-derived organoids, the in vitro activity of antibody-drug conjugates (ADCs)-including trastuzumab emtansine (an approved ADC administered intravenously)-that are either approved or currently in clinical trials was evaluated. In parallel, clinical patients provided ex vivo cytological assay results indicating their sensitivity to ADC therapy.",[13],"Drug: Antibody-drug conjugate (ADC) combination therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Antibody-drug conjugate (ADC) combination therapy","In a co-culture system of tumor patient-derived organoids (PDOs) and autologous immune cells, at least ten drug combinations comprising antibody-drug conjugates (ADCs) plus tyrosine kinase inhibitors (TKIs) or immune checkpoint blockers (ICBs) were employed to screen for ADCs with sensitivity against the tumor PDOs. The ADCs selected for evaluation included:\n\nTrastuzumab deruxtecan for injection (intravenous) Trastuzumab emtansine for injection (intravenous) Sacituzumab govitecan for injection (intravenous)",[9],[21,22,23],"ADC + TKI\u002FICB + Cellular Therapy DS-8201","ADC + TKI\u002FICB + Cellular Therapy T-DM1","ADC + TKI\u002FICB + Cellular Therapy SG",[25],{"name":26,"affiliation":27,"role":28},"Chengzhi Zhou, PhD","The First Affiliated Hospital of Guangzhou Medical University","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Chengzhi Professor Zhou, PhD","CONTACT","13560351186","13560351186@163.com",{"name":36,"role":32,"phone":37,"phoneExt":10,"email":38},"Xinqing Lin, PhD","18819281507","linxinging81@163.com",[40],{"facility":27,"status":41,"city":42,"state":43,"zip":10,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Guangzhou","Guangdong","China","CN",{"type":47,"coordinates":48},"Point",[49,50],113.25,23.11667,{"lat":50,"lon":49},[53,55,56],{"name":54,"role":32,"phone":33,"phoneExt":10,"email":34},"chengzhi Professor Zhou, PhD",{"name":36,"role":32,"phone":37,"phoneExt":10,"email":38},{"name":26,"role":28,"phone":10,"phoneExt":10,"email":10},{"type":28,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Zhou Chengzhi","Full Professor of Medical Oncology, Guangzhou Institute of Respiratory Disease","100637654","study-on-the-mechanism-of-adc-drug-evaluation-based-on-immune-co-culture-of-lung-cancer-organoids-100637654",false,"NCT07610616","Study on the Mechanism of ADC Drug Evaluation Based on Immune Co-culture of Lung Cancer Organoids","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Availability of patient-derived organoids (PDOs) with matched autologous tumor-infiltrating lymphocytes (TILs) or peripheral blood mononuclear cells (PBMCs) from non-small cell lung cancer (NSCLC) cases.\n* Patients currently undergoing or scheduled to receive Trastuzumab deruxtecan (T-DXd) therapy who meet clinical eligibility criteria.\n* Provision of written informed consent.\n* PDOs exhibiting strong positive HER2 and TROP2 expression by immunohistochemistry (IHC) assigned to the experimental group.\n* PDOs exhibiting weak positive HER2 and TROP2 expression by IHC assigned to the negative control group.\n\nExclusion Criteria:\n\n* PDOs derived from patients with pathologically confirmed small cell lung cancer (SCLC).\n* Unavailability of matched autologous PDOs, TILs, or PBMCs.\n* Presence of any contraindications to T-DXd treatment.\n* Presence of other serious comorbidities resulting in an estimated survival of \\\u003C3 months.\n* Pregnant or breastfeeding women.","ALL","18 Years","100 Years",{"count":70,"type":71},10,"ESTIMATED","OBSERVATIONAL","A case-control study was conducted to evaluate the efficacy and mechanism of action of antibody-drug conjugates (ADCs) in lung cancer, utilizing patient-derived organoid (PDO)-immune co-cultures. Focusing on HER2-positive and TROP2-positive non-small cell lung cancer (NSCLC) cases, ADC candidates were screened for in vitro activity based on organoid-immune interaction models.\n\nKey assessments included:\n\nTumor killing efficiency, assessed by dose-response relationships; Drug internalization (cellular uptake), as a measure of penetration into cancer cells; Antibody-dependent cellular cytotoxicity (ADCC) and bystander effect, with negative control targets employed to delineate specificity; Single-cell RNA sequencing, to profile transcriptional alterations at single-cell resolution.\n\nData demonstrated distinct ADC responses correlating with target expression and immune microenvironment features. The integrated approach provided cell-based evidence of ADC potency and revealed mechanistic insights-including immune-mediated cytotoxicity pathways and intracellular trafficking-supporting the rational design of clinical trials. These findings established a foundation for precision immunotherapy strategies and offered a mechanistic rationale for patient selection in HER2\u002FTROP2-positive lung cancer.",[75],"HER2 Positive OR TROP2 Positive Non-Small Cell Lung Cancer",[77,78,79],"Non-Small Cell Lung Cancer","HER2 Positive Non-Small Cell Lung Cancer","TROP2 Positive Non-Small Cell Lung Cancer","2026-05-25",{"date":82,"type":83},"2026-05-28","ACTUAL",{"date":85,"type":83},"2025-12-28",{"date":87,"type":71},"2027-10-01",{"name":5,"class":6},1]