A Trial for the Treatment of Advanced Large-Cell Neuroendocrine Cancer of the Lung
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTechnische Universität Dresden
About this trial
This phase II clinical trial evaluates the efficacy, safety and tolerability of Obrixtamig in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Obrixtamig
Treatment groups
75 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov