[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636127":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":20,"responsibleParty":34,"collaborators":20,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":20,"enrollmentInfo":46,"targetDuration":20,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":60,"whyStopped":20,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":20},{"fullName":5,"class":6},"Technische Universität Dresden","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Obrixtamig\u002FPlatinum\u002FEtoposide","EXPERIMENTAL","Obrixtamig\u002FPlatinum\u002FEtoposide. Platinum will be carboplatin.",[13],"Drug: Obrixtamig",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Obrixtamig","Obrixtamig (IMP) will be added to Platinum\u002FEtoposide (Standard-of-Care). Three cycles of combined immunochemotherapy 3qw will be followed by maintenance with obrixtamig monotherapy until progression.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Martin Wermke, Prof. Dr. med.","Technische Universität Dresden, Medizinische Fakultät","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+49 351 7566","martin.wermke@ukdd.de",{"name":32,"role":28,"phone":20,"phoneExt":20,"email":33},"Felix Carl Saalfeld, Dr. med.","felix.saalfeld@ukdd.de",{"type":35,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100636127","phase-2-a-trial-for-the-treatment-of-advanced-large-cell-neuroendocrine-cancer-of-the-lung-100636127",false,"NCT07561645","A Trial for the Treatment of Advanced Large-Cell Neuroendocrine Cancer of the Lung","A Phase II, Single-arm Trial on the Addition of the DLL3xCD3 Bispecific T-cell Engager Obrixtamig (BI 764532) to Standard-of-care Platinum-based First-line Treatment of Advanced Large-cell Neuroendocrine Carcinoma of the Lung","ALPINE 2","Inclusion Criteria: (main criteria)\n\n1. Patient has provided written informed consent and is able to consent\n2. Patients with pulmonary large-cell neuroendocrine carcinoma (LCNEC) defined by local histology and immunohistochemistry; patients with mixed histology are eligible if LCNEC is the predominant histology, i.e. ≥50%\n3. Patients with locally advanced or metastatic disease without curative treatment options\n4. All patients must have received one, but not more than one, cycle of platinum\u002Fetoposide chemotherapy with or without immune checkpoint inhibitor (standard-of-care; SoC). Other than that, patients must be previously untreated with systemic therapy.\n5. Measurable disease according to RECIST v1.11\n\nExclusion Criteria: (main criteria)\n\n1. Symptomatic brain metastases (Patients with asymptomatic brain metastases are allowed provided they are clinically stable, receiving no or a stable dose of anticonvulsants without steroid treatment for at least 3 weeks.)\n2. Known leptomeningeal disease\n3. Any prior systemic treatment for metastatic disease, except for one cycle of SoC as described under inclusion criteria\n4. Previous treatment with obrixtamig or any anti-DLL3 compound including T-cell engagers and antibody-drug conjugates","ALL","18 Years",{"count":47,"type":48},75,"ESTIMATED","INTERVENTIONAL",[51],"PHASE2","This phase II clinical trial evaluates the efficacy, safety and tolerability of Obrixtamig in addition to standard of care chemotherapy (Platinum\u002FEtoposide) in LCNEC.",[54],"Large Cell Neuroendocrine Carcinoma of the Lung",[56,57,58,59],"lung cancer","LCNEC","lung carcinoma","neuroendocrine carcinoma","NOT_YET_RECRUITING","2026-04-27",{"date":63,"type":64},"2026-05-01","ACTUAL",{"date":66,"type":48},"2026-07",{"date":68,"type":48},"2032-04",{"name":5,"class":6}]