Not Yet RecruitingPhase 2

A Trial for the Treatment of Advanced Large-Cell Neuroendocrine Cancer of the Lung

75 participantsStarted 2026-07

Plain-language summary

This phase II clinical trial evaluates the efficacy, safety and tolerability of Obrixtamig in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.)
✕. Known leptomeningeal disease
✕. 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

What they're measuring

Overall Survival (OS)

Timeframe: app. 69 months

Trial details

NCT IDNCT07561645

SponsorTechnische Universität Dresden

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2032-04

Contact for this trial

Martin Wermke, Prof. Dr. med.

+49 351 7566 martin.wermke@ukdd.de

View on ClinicalTrials.gov More Large Cell Neuroendocrine Carcinoma of the Lung trials