[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628284":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":29,"locations":35,"responsibleParty":49,"collaborators":51,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":28,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":28,"enrollmentInfo":63,"targetDuration":28,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":73,"whyStopped":28,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Jazz Pharmaceuticals","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Durvalumab and lurbinectedin treatment arm","EXPERIMENTAL","Durvalumab taken in combination with lurbinectedin in participants with ES-SCLC after first line induction therapy with durvalumab and platinum plus etoposide containing regimen.",[13,14],"Drug: Lurbinectedin","Drug: Durvalumab",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Lurbinectedin","Administered by intravenous (IV) infusion",[9],[22],"Zepzelca",{"type":17,"name":24,"description":19,"armGroupLabels":25,"otherNames":26},"Durvalumab",[9],[27],"Imfinzi",null,[30],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Clinical Trial Disclosure & Transparency","CONTACT","215-832-3750","ClinicalTrialDisclosure@JazzPharma.com",[36],{"facility":37,"status":28,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":28},"Valkyrie Clinical Trials, Inc.","Los Angeles","California","90067","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-118.24368,34.05223,{"lat":47,"lon":46},{"type":50,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[52],{"name":53,"class":6},"Jazz Pharmaceuticals Ireland Limited","100628284","phase-2-a-study-of-lurbinectedin-in-combination-with-durvalumab-for-the-treatment-of-participants-with-es-sclc-100628284",false,"NCT07459634","A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC","A Phase 2, Multicenter, Open-Label, Single-Arm Study of Lurbinectedin in Combination With Durvalumab as First-line Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer Following Induction Treatment With Platinum Based Chemotherapy and Durvalumab","Inclusion Criteria:\n\n1. Participant has histologically or cytologically confirmed ES-SCLC (per Veterans Administration Lung Study Group staging system).\n2. Participant has received 4 cycles of definitive platinum-based chemotherapy with durvalumab\n3. Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n4. Must have a life expectancy of ≥ 12 weeks as assessed by the treating physician.\n5. Adequate hematologic and end-organ function for at least 7 days prior to dosing.\n6. Has a body weight \\> 30 kg.\n7. Adequate contraceptive precautions.\n\nExclusion Criteria:\n\n1. History of leptomeningeal carcinomatosis.\n2. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\n3. History of another primary malignancy\n4. Presence or history of Central Nervous System (CNS) metastases\n5. History of allogeneic organ transplantation.\n6. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest CT scan.\n7. Any concurrent chemotherapy, study intervention, biologic, or hormonal therapy for cancer treatment.\n8. Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention.\n9. Concurrent enrollment in another clinical study\n10. Prior enrollment or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.\n11. Pregnant or breastfeeding or intending to become pregnant during the study or within 6 months after the last dose of study intervention.","ALL","18 Years",{"count":64,"type":65},50,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of lurbinectedin in combination with durvalumab for the treatment of participants with extensive stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first line (1L) induction therapy.",[71],"Extensive-stage Small-cell Lung Cancer",[22,18,24,27],"NOT_YET_RECRUITING","2026-05-22",{"date":76,"type":77},"2026-05-27","ACTUAL",{"date":79,"type":65},"2026-06-12",{"date":81,"type":65},"2028-04-30",{"name":5,"class":6},1]