[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053537":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":33,"interventions":40,"overallOfficials":26,"centralContacts":46,"locations":52,"responsibleParty":82,"collaborators":26,"id":84,"slug":26,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":26,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":26,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":26,"overallStatus":102,"whyStopped":26,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"Number of Participants With Abnormal Laboratory Values and\u002For Adverse Events That Are Related to Treatment","adverse events (AEs) and serious adverse events (SAEs), dose-limiting toxicities (DLTs), clinically significant abnormal laboratory results, etc.","From enrollment to the end of treatment at 24 months",{"measure":14,"description":15,"timeFrame":12},"ORR(objective response rate)","ORR as assessed by the investigator based on RECIST v1.1",[17,20,22,24],{"measure":18,"description":19,"timeFrame":12},"DCR(Disease control rate )","as assessed by the investigator based on RECIST v1.1",{"measure":21,"description":19,"timeFrame":12},"DOR(duration of response )",{"measure":23,"description":19,"timeFrame":12},"PFS(progression-free survival)",{"measure":25,"description":26,"timeFrame":12},"OS (overall survival)",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"NA","SINGLE_GROUP","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE",[34],{"label":35,"type":36,"description":37,"interventionNames":38},"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",[39],"Drug: SKB264+SKB118",[41],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":26},"DRUG","SKB264+SKB118","Administered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle.",[35],[47],{"name":48,"role":49,"phone":50,"phoneExt":26,"email":51},"Yan Qing Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","CONTACT","028-67255480","qingyan@kelun.com",[53,69],{"facility":54,"status":26,"city":55,"state":26,"zip":26,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Jilin Cancer Hospital","Jilin City","China","CN",{"type":59,"coordinates":60},"Point",[61,62],126.5608,43.84652,{"lat":62,"lon":61},[65],{"name":66,"role":49,"phone":67,"phoneExt":26,"email":68},"Haifeng Liu","0431-80596336","HFLIU2025@163.com",{"facility":70,"status":26,"city":71,"state":26,"zip":26,"country":56,"countryCode":57,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Shanghai East Hospital, Tongji University","Shanghai",{"type":59,"coordinates":73},[74,75],121.45806,31.22222,{"lat":75,"lon":74},[78],{"name":79,"role":49,"phone":80,"phoneExt":26,"email":81},"Caicun Zhou","13301825532","caicunzhoudr@163.com",{"type":83,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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":94,"type":95},206,"ESTIMATED","INTERVENTIONAL",[98],"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.",[101],"NSCLC","NOT_YET_RECRUITING","2026-07-10",{"date":105,"type":106},"2026-07-13","ACTUAL",{"date":108,"type":95},"2026-08",{"date":110,"type":95},"2029-08",{"name":5,"class":6},2]