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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with large-cell neuroendocrine lung cancer that has spread or cannot be cured by local treatment. They have had one cycle of platinum/etoposide chemotherapy.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Large-cell neuroendocrine carcinoma (LCNEC) of the lung, locally advanced or metastatic, with no curative treatment options. If the tumour has mixed cell types, LCNEC must be at least 50%. The disease must be measurable (RECIST v1.11).
- Earlier treatment
- Must have had one, but not more than one, cycle of platinum/etoposide chemotherapy, with or without an immune checkpoint inhibitor. No other earlier treatment of the whole body (systemic therapy).
Main reasons for not taking part
- Brain metastases with symptoms (stable ones without symptoms are allowed)
- Known leptomeningeal disease
- Any earlier systemic treatment for spread disease, except the one cycle of standard chemotherapy
- Earlier treatment with obrixtamig or any anti-DLL3 drug
Read by machine on 13 November 2026.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.