[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053537":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":57,"collaborators":20,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":20,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":20,"overallStatus":78,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SKB264 in combination with SKB118","EXPERIMENTAL","SKB264 at 4 mg\u002Fkg combined with SKB118 at 3 mg\u002Fkg, 10 mg\u002Fkg, 20 mg\u002Fkg, or other dose levels",[13],"Drug: SKB264+SKB118",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","SKB264+SKB118","Administered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Yan Qing Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","CONTACT","028-67255480","qingyan@kelun.com",[28,44],{"facility":29,"status":20,"city":30,"state":20,"zip":20,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Jilin Cancer Hospital","Jilin City","China","CN",{"type":34,"coordinates":35},"Point",[36,37],126.5608,43.84652,{"lat":37,"lon":36},[40],{"name":41,"role":24,"phone":42,"phoneExt":20,"email":43},"Haifeng Liu","0431-80596336","HFLIU2025@163.com",{"facility":45,"status":20,"city":46,"state":20,"zip":20,"country":31,"countryCode":32,"cosmosGeoPoint":47,"geoPoint":51,"contacts":52},"Shanghai East Hospital, Tongji University","Shanghai",{"type":34,"coordinates":48},[49,50],121.45806,31.22222,{"lat":50,"lon":49},[53],{"name":54,"role":24,"phone":55,"phoneExt":20,"email":56},"Caicun Zhou","13301825532","caicunzhoudr@163.com",{"type":58,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100053537","phase-2-skb264-in-combination-with-skb118-for-non-small-cell-lung-cancer-100053537",false,"NCT07697586","SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer","A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced or metastatic NSCLC\n* Without epidermal growth factor receptor (EGFR) sensitizing mutation, and anaplastic lymphoma kinase (ALK) fusion gene.\n* Provide a tumor tissue sample.\n* At least one measurable lesion as assessed by the investigator according to RECIST v1.1.\n* ECOG performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks.\n* Adequate bone marrow, liver, kidney, and coagulation function.\n* Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.\n\nExclusion Criteria:\n\n* Histologically or cytologically confirmed co-existing small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components.\n* Participants with known metastases to meninges, brainstem metastases, metastases to spinal cord and\u002For compression, or active metastases to central nervous system (CNS).\n* Uncontrolled systemic disease as judged by the investigator.\n* Presence of uncontrolled, clinically symptomatic, or requiring repeated drainage pleural effusion, pericardial effusion, or ascites.\n* Presence of other moderate to severe lung disorders.\n* History of haemorrhagic diathesis or coagulopathy and\u002For clinically significant bleeding symptoms or risks.\n* Previous or co-existing gastrointestinal diseases, surgery, and wound healing complications.\n* Active hepatitis b or hepatitis c or co-infection with HBV and HCV.\n* Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.\n* Known hypersensitivity to the study drug or any of its components.\n* Pregnant or lactating women.","ALL","18 Years","75 Years",{"count":70,"type":71},206,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","This is an open-label, multi-center, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with NSCLC. The study includes a dose escalation phase and an expansion phase.",[77],"NSCLC","NOT_YET_RECRUITING","2026-07-10",{"date":81,"type":82},"2026-07-13","ACTUAL",{"date":84,"type":71},"2026-08",{"date":86,"type":71},"2029-08",{"name":5,"class":6},2]