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DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy

StatusRecruiting
PhasePhase 3
Started2026-07-10
View on ClinicalTrials.gov ↗

Amendment history

2026-09-14
minor
Study Status, Contacts/Locations v11
Study sites167 entries, revised
HenanThe CancerOhio HospitalState University Wexner Medical Center Hospital LusíadasLusiadas Lisboa Hospital Regional Universitario de MálagaMalaga Hospital Virgen del RocíoRocio
2026-09-01
minor
Study Status, Contacts/Locations v10
Study sites167 entries, revised
Instituto OncológicoOncologico FALP
2026-08-18
minor
Study Status, Contacts/Locations v9
Trial sites expanded: 164 → 167 locations
2026-08-05
minor
Study Identification, Study Status, Contacts/Locations v8
Study sites165→164
2026-07-21
notable
Study Status, Contacts/Locations v7
Recruitment opened
Start dateestimated 2026-07-07→confirmed 2026-07-10
Study sitesdetails revised at 165 of 165 sites
2026-07-10
minor
Study Identification, Study Status, Conditions, Contacts/Locations v6
Study sites166→165
Study title+8 characters
DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy
2026-07-06
minor
Study Status, Contacts/Locations v5
Completion pushed: 2029-12-13 → 2031-03-11
Start date2026-06-15→2026-07-07
Study sites166 entries, revised
Medical University of Graz EdegemUniversitair - UNIV UZZiekenhuis Antwerpen
2026-06-08
minor
Study Status, Contacts/Locations v4
Study sites165→166
2026-05-26
minor
Study Status, Contacts/Locations v3
Study sites163→165
2026-05-04
minor
Study Identification, Study Status, Contacts/Locations v2
Trial sites expanded: 158 → 163 locations
Completion moved earlier: 2030-05-15 → 2029-12-13
Study title+1 characters
DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuro [...]
2026-04-24
minor
Study Identification, Study Status, Conditions, Outcome Measures, Contacts/Locations v1
Trial sites expanded: 151 → 158 locations
Secondary endpoints9 entries, revised
Change from baseline to Week 19 in the physical functioning domain of the in mean change from baseline to Week 19 in the physical functioning domain using the EORTC QLQ-C30
Study title+14 characters
DAREON-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrin [...]
2026-04-16
minor
Original filing
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.
Trial Details
NCT Number NCT07544654
Lead Sponsor Boehringer Ingelheim
Conditions Extrapulmonary Neuroendocrine Cancer (epNEC)
Enrollment 390 participants
Start Date 2026-07-10
Primary Completion 2029-12-13 (estimated)
Study Completion 2031-03-11 (estimated)
Updated on ClinicalTrials.gov 2026-09-29