[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506439":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":42,"centralContacts":46,"locations":51,"responsibleParty":67,"collaborators":35,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":35,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":35,"enrollmentInfo":78,"targetDuration":35,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":54,"whyStopped":35,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Pharmacosmos A\u002FS","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Trilaciclib (G1T28) 240 mg\u002Fm² + Topotecan 1.5 mg\u002Fm²","EXPERIMENTAL","Patients randomized 1:1 to trilaciclib. Patients receive trilaciclib (240 mg\u002Fm²) administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.\n\nFollowing administration of trilaciclib on Days 1 to 5, patients receive topotecan (1.5 mg\u002Fm²)",[13,14],"Drug: Trilaciclib","Drug: Topotecan",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo + Topotecan 1.5 mg\u002Fm²","PLACEBO_COMPARATOR","Patients are randomized 1:1 to placebo. Patients receive placebo administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.\n\nFollowing administration of placebo on Days 1 to 5, patients receive topotecan (1.5 mg\u002Fm²).",[20,14],"Drug: Placebo",[22,31,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Trilaciclib","Participants will receive intravenous trilaciclib infusion",[9],[28,29,30],"G1T28","CDK 4\u002F6 inhibitor","cyclin-dependent kinase 4\u002F6 inhibitor",{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Placebo","Participants will receive intravenous placebo infusion",[16],null,{"type":23,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Topotecan","Participants will receive intravenous topotecan infusion",[16,9],[41],"Hycamtin",[43],{"name":44,"affiliation":5,"role":45},"Pharmacosmos Clinical and non-clinical Department","STUDY_DIRECTOR",[47],{"name":44,"role":48,"phone":49,"phoneExt":35,"email":50},"CONTACT","+45 5948 5959","info@pharmacosmos.com",[52],{"facility":53,"status":54,"city":55,"state":35,"zip":35,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Hospital","RECRUITING","Seville","Spain","ES",{"type":59,"coordinates":60},"Point",[61,62],-5.97317,37.38283,{"lat":62,"lon":61},[65],{"name":66,"role":48,"phone":35,"phoneExt":35,"email":35},"MD, MD",{"type":68,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100506439","phase-4-trilaciclib-vs-placebo-in-patients-with-extensive-stage-small-cell-lung-cancer-es-sclc-receiving-topotecan-100506439",false,"NCT05874401","Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan","A Randomized, Double-Blind, Placebo-Controlled Study of Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Chemotherapy","Inclusion Criteria:\n\n1. ES-SCLC with confirmed diagnosis of SCLC by histology or cytology\n2. Progression during or after prior first or second line chemotherapy. First-line regimen must have been a platinum-containing combination.\n3. Measurable or evaluable disease as defined by RECIST v1.1\n\nExclusion Criteria:\n\n1. History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment for SCLC\n2. Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment within 3 weeks, except for adjuvant hormonal therapy for breast cancer and prostate cancer\n3. Presence of brain metastases\u002Fleptomeningeal disease requiring immediate treatment with radiation therapy or steroids\n4. Radiotherapy within 2 weeks\n5. History of ILD\u002Fpneumonitis\n6. History of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥ 2 years or other NCS cancers","ALL","18 Years",{"count":79,"type":80},302,"ESTIMATED","INTERVENTIONAL",[83],"PHASE4","This is a multicenter, randomized, double-blind, placebo-controlled study to assess whether trilaciclib administered prior to topotecan is non-inferior to placebo administered prior to topotecan with regard to overall survival.",[86],"Extensive-stage Small-cell Lung Cancer",[88,89,90,91,92,93],"myelosuppression","ES-SCLC","chemotherapy-induced myelosuppression","chemotherapy-induced neutropenia","chemotherapy-induced anemia","myeloprotection","2025-08-27",{"date":96,"type":97},"2025-09-04","ACTUAL",{"date":99,"type":97},"2023-10-18",{"date":101,"type":80},"2027-10-30",{"name":5,"class":6},1]