[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638863":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":40,"centralContacts":44,"locations":49,"responsibleParty":51,"collaborators":49,"id":53,"slug":49,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":49,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":49,"enrollmentInfo":61,"targetDuration":49,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":77,"overallStatus":80,"whyStopped":49,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":49},{"fullName":5,"class":6},"SystImmune Inc.","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days",[13],"Drug: BL-M14D1 and Atezolizumab",{"label":15,"type":10,"description":11,"interventionNames":16},"Arm B",[13],{"label":18,"type":19,"description":20,"interventionNames":21},"Arm C","ACTIVE_COMPARATOR","Medications used in the Control Arm should be administered per local label or institutional guidelines.\n\nInduction therapy (4 cycles):\n\nCarboplatin (AUC of 5 mg\u002FmL\\*min IV) on Day 1 of each 21-day cycle Etoposide (100 mg\u002Fm2 IV) on Days 1 through 3 of each 21-day cycle Atezolizumab (1200 mg) IV on Day 1 of each 21-day cycle\n\nMaintenance therapy (continues until discontinuation criteria are met):\n\nAtezolizumab (1200 mg) IV on Day 1 of each 21-day cycle Lurbinectedin (3.2 mg\u002Fm2) IV on Day 1 of each 21-day cycle (to be added only if approved in region and as per PI discretion)",[22],"Drug: Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin",[24,32],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","BL-M14D1 and Atezolizumab","BL-M14D1 administered in combination with atezolizumab. BL-M14D1 will be given intravenously at the protocol-specified dose and schedule. Atezolizumab will be administered intravenously according to the approved dosing regimen.",[9,15],[30,31],"BL-M14D1","Atezolizumab",{"type":25,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin","Carboplatin and etoposide will be administered intravenously in combination with atezolizumab for induction therapy, followed by maintenance treatment with atezolizumab with or without lurbinectedin per protocol.",[18],[37,31,38,39],"Etoposide","Lurbinectedin","Carboplatin",[41],{"name":42,"affiliation":5,"role":43},"Rishi Jain, MD","STUDY_DIRECTOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Beth Metzheiser","CONTACT","425-453-6841",null,"beth.metzheiser@systimmune.com",{"type":52,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100638863",false,"NCT07625644","Evaluate BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer","A Phase 3 Open-Label, Randomized Controlled Trial of BL-M14D1 and Atezolizumab vs. Standard-of-Care Therapy in Patients With First-Line Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed first-line (1L), extensive-stage (ES) small cell lung cancer (SCLC)\n* Must be eligible to receive a platinum-based chemotherapy regimen in combination with an anti-PD-L1 inhibitor.\n* At least one measurable lesion based on RECIST v1.1 per investigator assessment.\n* An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Received any kind of platinum or etoposide treatment for limited stage (LS) SCLC within 6 months prior to enrollment.\n* Participants who have received prior topoisomerase inhibitor-based ADC therapy.\n* Participants with history of severe heart disease\n* Participants with active autoimmune diseases and inflammatory diseases,\n* Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and\u002For carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.","ALL","18 Years",{"count":62,"type":63},550,"ESTIMATED","INTERVENTIONAL",[66],"PHASE3","The objective of the study is to evaluate the efficacy and safety of BL-M14D1 in combination with Atezolizumab compared to Standard-of-Care Therapy in adult participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).",[69,70,71,72,73,74,75,76],"Small Cell Lung Cancer Extensive Stage","Small-cell Lung Cancer","Small Cell Carcinoma","Sclc","SCLC,Extensive Stage","Lung Cancer","Lung Cancer Metastatic","Lung Cancer Stage IV",[78,79],"DLL3","First Line","NOT_YET_RECRUITING","2026-05-28",{"date":83,"type":84},"2026-06-04","ACTUAL",{"date":86,"type":63},"2026-06",{"date":88,"type":63},"2031-06",{"name":5,"class":6}]