Obrixtamig added to chemotherapy for advanced large-cell neuroendocrine lung cancer
Tests obrixtamig plus standard chemotherapy in adults with advanced large-cell neuroendocrine lung cancer.
Plain-language title generated from the registry record
Registry title: A Trial for the Treatment of Advanced Large-Cell Neuroendocrine Cancer of the Lung
Key facts
- Where
- Berlin, Dresden, Essen, Frankfurt Am Main, Gauting, Grosshansdorf, Heidelberg, Hemer, Mainz, Oldenburg, and Stuttgart, GermanySee the 11 sites
- Phase
- Phase 2
Where in Germany
- Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbHBerlin, GermanyNot yet recruiting
- Technische Universitaet DresdenDresden, GermanyNot yet recruiting
- Universitaetsklinikum Essen (AoR)Essen, GermanyNot yet recruiting
- Goethe University FrankfurtFrankfurt Am Main, GermanyNot yet recruiting
- Asklepios Klinik Gauting GmbHGauting, GermanyNot yet recruiting
- LungenClinic Grosshansdorf GmbHGrosshansdorf, GermanyNot yet recruiting
- Thoraxklinik Heidelberg gGmbHHeidelberg, GermanyNot yet recruiting
- Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbHHemer, GermanyNot yet recruiting
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, GermanyNot yet recruiting
- Pius Hospital OldenburgOldenburg, GermanyNot yet recruiting
- Robert Bosch Gesellschaft fuer medizinische Forschung mbHStuttgart, GermanyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Technische Universität Dresden
- Trial code
- NCT07561645EU 2025-524345-28-00
- Record updated
- 26 August 2026
- Original description
This phase II clinical trial evaluates the efficacy, safety and tolerability of Obrixtamig in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.Read full original descriptionShow less
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
This phase II clinical trial evaluates the efficacy, safety and tolerability of Obrixtamig in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.
Inclusion: Patient has provided written informed consent and is able to consent; 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%; Patients with locally advanced or metastatic disease without curative treatment options; All patients must have received one, but not more than one, cycle of platinum/etoposide chemotherapy with or without immune checkpoint inhibitor (standard-of-care; SoC). Other than that, patients must be previously untreated with systemic therapy; Measurable disease according to RECIST v1.11.
Exclusion: 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.); Any prior systemic treatment for metastatic disease, except for one cycle of SoC as described under inclusion criteria; Previous treatment with obrixtamig or any anti-DLL3 compound including T-cell engagers and antibody-drug conjugates; Known leptomeningeal disease.