[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554391":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":29,"responsibleParty":148,"collaborators":25,"id":150,"slug":151,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":25,"eligibilityCriteria":156,"healthyVolunteers":152,"sex":157,"minAge":158,"maxAge":25,"enrollmentInfo":159,"targetDuration":25,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":25,"overallStatus":73,"whyStopped":25,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"Hansoh BioMedical R&D Company","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HS-20093","EXPERIMENTAL","Participants will receive HS-20093 as an intravenous (IV) infusion at dose of 8.0 mg\u002Fkg on Day 1 of each 21-day cycle until a treatment discontinuation criterion is met as specified in the protocol.",[13],"Drug: HS-20093",{"label":15,"type":16,"description":17,"interventionNames":18},"Topotecan","ACTIVE_COMPARATOR","Participants will receive topotecan until a treatment discontinuation criterion is met as specified in the protocol.",[19],"Drug: Topotecan",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","HS-20093 will be administered as an IV infusion at dose of 8.0 mg\u002Fkg on Day 1 of each 21-day cycle.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Topotecan will be administered per drug label.",[15],[30,47,59,71,89,101,113,126,137],{"facility":31,"status":32,"city":33,"state":34,"zip":25,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Beijing Cancer Hospital","NOT_YET_RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":38,"coordinates":39},"Point",[40,41],116.39723,39.9075,{"lat":41,"lon":40},[44],{"name":45,"role":46,"phone":25,"phoneExt":25,"email":25},"Jian Fang","PRINCIPAL_INVESTIGATOR",{"facility":48,"status":32,"city":49,"state":50,"zip":25,"country":35,"countryCode":36,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Harbin Medical University Cancer Hospital","Harbin","Heilongjiang",{"type":38,"coordinates":52},[53,54],126.65,45.75,{"lat":54,"lon":53},[57],{"name":58,"role":46,"phone":25,"phoneExt":25,"email":25},"Baogang Liu",{"facility":60,"status":32,"city":61,"state":62,"zip":25,"country":35,"countryCode":36,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Henan Cancer Hospital","Zhengzhou","Henan",{"type":38,"coordinates":64},[65,66],113.64861,34.75778,{"lat":66,"lon":65},[69],{"name":70,"role":46,"phone":25,"phoneExt":25,"email":25},"Qiming Liu",{"facility":72,"status":73,"city":74,"state":75,"zip":25,"country":35,"countryCode":36,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Jilin Cancer Hospital","RECRUITING","Changchun","Jilin",{"type":38,"coordinates":77},[78,79],125.32278,43.88,{"lat":79,"lon":78},[82,87],{"name":83,"role":84,"phone":85,"phoneExt":25,"email":86},"Ning Zhangning","CONTACT","0431-80596067","JPCHIRB@163.com",{"name":88,"role":46,"phone":25,"phoneExt":25,"email":25},"Ying Cheng",{"facility":90,"status":32,"city":91,"state":92,"zip":25,"country":35,"countryCode":36,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Shengjing Hospital of China Medical University","Shenyang","Liaoning",{"type":38,"coordinates":94},[95,96],123.43278,41.79222,{"lat":96,"lon":95},[99],{"name":100,"role":46,"phone":25,"phoneExt":25,"email":25},"Wei Zheng",{"facility":102,"status":32,"city":103,"state":104,"zip":25,"country":35,"countryCode":36,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Shandong Cancer Hospital","Jinan","Shandong",{"type":38,"coordinates":106},[107,108],116.99722,36.66833,{"lat":108,"lon":107},[111],{"name":112,"role":46,"phone":25,"phoneExt":25,"email":25},"Haiyong Wang",{"facility":114,"status":32,"city":115,"state":116,"zip":25,"country":35,"countryCode":36,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Shanghai Pulmonary Hospital","Shanghai","Shanghai Municipality",{"type":38,"coordinates":118},[119,120],121.45806,31.22222,{"lat":120,"lon":119},[123,125],{"name":124,"role":84,"phone":25,"phoneExt":25,"email":25},"Peng Zhang",{"name":124,"role":46,"phone":25,"phoneExt":25,"email":25},{"facility":127,"status":32,"city":128,"state":25,"zip":25,"country":35,"countryCode":36,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"The First Affiliate Hospital of GUANGZHOU Medical University","Guangzhou",{"type":38,"coordinates":130},[131,132],113.25,23.11667,{"lat":132,"lon":131},[135],{"name":136,"role":46,"phone":25,"phoneExt":25,"email":25},"Ming Liu",{"facility":138,"status":32,"city":139,"state":25,"zip":25,"country":35,"countryCode":36,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Tongji Hospital","Wuhan",{"type":38,"coordinates":141},[142,143],114.26667,30.58333,{"lat":143,"lon":142},[146],{"name":147,"role":46,"phone":25,"phoneExt":25,"email":25},"Qian Chu",{"type":149,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100554391","phase-3-artemis-008hs-20093-compared-with-topotecan-in-subjects-with-relapsed-small-cell-lung-cancer-100554391",false,"NCT06498479","ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer","ARTEMIS-008：A Multicenter, Randomized, Open-label, Phase 3 Study of HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy","Inclusion Criteria:\n\n1. Male or female subjects ≥18 years of age.\n2. Histologically or cytologically confirmed SCLC.\n3. Subjects who progressed on or after first-line platinum-based regimens.\n4. Has at least 1 measurable lesion as defined per RECIST 1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n6. Minimum life expectancy of more than 12 weeks.\n7. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.\n8. Men or women should be using adequate contraceptive measures throughout the study.\n9. Subject has provided informed consent\u002Fassent prior to initiation of any study specific activities\u002Fprocedures.\n\nExclusion Criteria:\n\n1. Combined SCLC, any previous diagnosis of transformed SCLC or SCLC that has transformed to NSCLC.\n2. Chemotherapy-free interval ≤30 days.\n3. Has received prior treatment with anti-B7 homologue 3 (B7-H3) targeted agents.\n4. Has received prior treatment with topoisomerase I inhibitor, including ADC that consists of topoisomerase I inhibitor.\n5. Has inadequate washout period before randomization as specified in the protocol.\n6. Untreated or symptomatic brain metastases with exceptions defined in the protocol.\n7. Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 with exceptions defined in the protocol.\n8. History of other malignancy with exceptions defined in the protocol.\n9. Inadequate bone marrow reserve or organ dysfunction.\n10. Evidence of cardiovascular risks.\n11. Severe, uncontrolled or active cardiovascular diseases.\n12. Severe or uncontrolled diabetes.\n13. Severe or uncontrolled high blood pressure.\n14. Clinically significant bleeding or obvious bleeding tendency within 1 month before randomization.\n15. Severe arterial or venous thromboembolic events within 3 months prior to randomization.\n16. Severe infections within 4 weeks before randomization.\n17. Receiving systemic corticosteroid therapy within 30 days prior to randomization with exceptions defined in the protocol.\n18. The presence of active infectious diseases before randomization.\n19. Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis.\n20. History of interstitial lung disease, immunotherapy-induced pneumonitis, clinically moderate or severe pulmonary disease.\n21. History of severe neuropathy or mental disorders.\n22. Female subjects of childbearing potential; female subjects who are breastfeeding or who plan to breastfeed while on study; female subjects planning to become pregnant while on study.\n23. Vaccination or hypersensitivity of any level within 4 weeks before randomization.\n24. History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins.\n25. Hypersensitivity to any ingredient of HS-20093, DNA topoisomerase I inhibitor or regimens of Topotecan.","ALL","18 Years",{"count":160,"type":161},460,"ESTIMATED","INTERVENTIONAL",[164],"PHASE3","The main objective of this study is to compare the efficacy of HS-20093 with standard of care (SOC) on prolonging overall survival (OS) in subjects with relapsed small cell lung cancer (SCLC).",[167],"Small Cell Lung Cancer","2024-10-15",{"date":170,"type":171},"2024-10-16","ACTUAL",{"date":173,"type":171},"2024-07-04",{"date":175,"type":161},"2027-05-31",{"name":5,"class":6},9]