A Trial for the Treatment of Advanced Large-Cell Neuroendocrine Cancer of the Lung
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Obrixtamig.
- Who it may be relevant to
- Registry conditions: Large Cell Neuroendocrine Carcinoma of the Lung. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
This phase II clinical trial evaluates the efficacy, safety and tolerability of Obrixtamig in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.
Interventions
- Drug Obrixtamig
Obrixtamig (IMP) will be added to Platinum/Etoposide (Standard-of-Care). Three cycles of combined immunochemotherapy 3qw will be followed by maintenance with obrixtamig monotherapy until progression.
Primary outcome measures
- Overall Survival (OS) [Time frame: app. 69 months]
Secondary outcome measures (6)
- Objective Response Rate (ORR) [Time frame: app. 69 months]
- Progression-Free Survival (PFS) [Time frame: app. 69 months]
- Duration Of Response (DOR) [Time frame: app. 69 months]
- Disease Control Rate (DCR) [Time frame: app. 69 months]
- immune Objective Response Rate (iORR) [Time frame: app. 69 months]
- immune Progression Free Survival (iPFS) [Time frame: appr. 69 months]
Eligibility criteria
Inclusion Criteria: (main 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: (main 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07561645 · TUD-ALPIN2-089 · 2025-524345-28-00