Clinical trial · Interventional
A Trial for the Treatment of Advanced Large-Cell Neuroendocrine Cancer of the Lung
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
NCT07561645CI-TRIAL-00123810ALPINE 2not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II clinical trial evaluates the efficacy, safety and tolerability of Obrixtamig in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Large Cell Neuroendocrine Carcinoma of the Lung | Lung Large Cell Neuroendocrine Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Obrixtamig | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Obrixtamig/Platinum/Etoposide
- description
- Obrixtamig/Platinum/Etoposide. Platinum will be carboplatin.
- interventionNames
- Drug: Obrixtamig
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- app. 69 months
- description
- To assess the efficacy of Obrixtamig in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC as measured by overall survival.
Secondary outcomes (6)
- measure
- Objective Response Rate (ORR)
- timeFrame
- app. 69 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: (main criteria) 1. Patient has provided written informed consent and is able to consent 2. 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% 3. Patients with locally advanced or metastatic disease without curative treatment options 4. 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. 5. Measurable disease according to RECIST v1.11 Exclusion Criteria: (main criteria) 1. 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.) 2. Known leptomeningeal disease 3. Any prior systemic treatment for metastatic disease, except for one cycle of SoC as described under inclusion criteria 4. Previous treatment with obrixtamig or any anti-DLL3 compound including T-cell engagers and antibody-drug conjugates
References
Publications (0)
Data not yet available
No reference posted for this study.