A Phase 3 interventional study of Obrixtamig and Carboplatin in Extrapulmonary Neuroendocrine Cancer (epNEC), sponsored by Boehringer Ingelheim. Recruiting at 167 sites in 29 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
This study is open to adults with advanced extrapulmonary neuroendocrine cancer. The purpose of this study is to find out if a study medicine called obrixtamig plus standard chemotherapy (carboplatin and etoposide) improves survival when compared to standard chemotherapy (carboplatin and etoposide) alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker delta-like ligand 3 (DLL3).
Participants are put into 2 groups randomly, which means by chance. One group (treatment arm) receives obrixtamig and standard chemotherapy followed by obrixtamig alone for up to 3 years. The other group (control arm) receives standard chemotherapy without obrixtamig for about 4 months. All treatments are given as infusions into a vein.
During the study, participants in both groups visit the study site regularly. Participants in the treatment arm stay overnight at the study site following the first 2 obrixtamig treatments. The doctors regularly check participants' health and take note of any unwanted effects. At some of the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works.
Exclusion Criteria:
Treatment arm
Drug: Obrixtamig · Drug: Carboplatin · Drug: Etoposide · Device: Ventana DLL3 RxDx assay
Control arm
Drug: Carboplatin · Drug: Etoposide · Device: Ventana DLL3 RxDx assay
Obrixtamig
Carboplatin
Etoposide
Ventana DLL3 RxDx assay
Overall survival (OS)
defined as the time from randomisation until death from any cause
Time frame: Up to 38 months
Progression-free survival (PFS)
defined as the time from randomisation until the earliest date of disease progression according to RECIST 1.1 based on investigator assessments or death from any cause, whichever occurs first
Time frame: Up to 38 months
Change from baseline to Week 19 in the physical functioning domain of the EORTC QLQ-C30
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) includes 1 global health status/QoL scale, 5 functional scales, 3 symptoms scales and 6 single items to assess dyspnea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties. Each score 0-100. Global health status higher = better, functional scale higher = better, symptom scale higher = worse
Time frame: At baseline, up to week 19
Objective response (OR)
defined as a best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 (based on investigator assessments) from randomisation until the earliest date of disease progression, death, last evaluable tumour assessment before the start of next line of anti-cancer treatment, loss to follow-up, or withdrawal of consent
Time frame: Up to 38 months
Duration of response (DoR)
defined as the time from the first documented OR according to RECIST 1.1 until the earliest date of disease progression or death among patients with objective response based on investigator assessments
Time frame: Up to 38 months
Disease control (DC)
defined as best overall response of complete response (CR) or partial response (PR) or stable disease (SD) where best overall response is defined according to RECIST 1.1 based on investigator assessments from randomisation until the earliest of disease progression, death or last evaluable tumour assessment before start of next line of anti-cancer treatment, loss to follow-up or withdrawal of consent
Time frame: Up to 38 months
Occurrence of treatment-emergent Grade 3 or greater Cytokine release syndrome (CRS)
Time frame: Up to 38 months
Occurrence of treatment-emergent Grade 3 or greater Immune cell associated neurotoxicity syndrome (ICANS)
Time frame: Up to 38 months
Occurrence of treatment-emergent adverse events (AEs) leading to permanent discontinuation of trial medication during the on-treatment period
Time frame: Up to 38 months
Occurrence of treatment-emergent AEs leading to dose modification of trial medication (i.e. dose interruption, dose delay, dose reduction)
Time frame: Up to 38 months
Showing the first 100 of 167 sites across 29 countries.
Plan to share: Yes — Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Supporting information: Study protocol, Sap, Csr
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