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NCT07544654 · ClinicalTrials.gov registry record · Phase 3
DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Not yet
- Registry status
- Phase 3
- Development phase
- 390
- Enrollment target
NCT07544654: Clinical Trial Phase 3 study, sponsored by Boehringer Ingelheim.
NCT07544654 is a Phase 3 study that has not yet begun recruiting, run by Boehringer Ingelheim. The registered enrollment target is 390 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07544654, a Phase 3 study, has not yet begun recruiting, sponsored by Boehringer Ingelheim.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 390 participants
- Enrollment target
Study Summary
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.
Primary Outcome
defined as the time from randomisation until death from any cause
Interventions
- DRUG Carboplatin
- DRUG Etoposide
- DRUG Obrixtamig
- DEVICE Ventana DLL3 RxDx assay
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2026-07-07 |
| Est. Completion | 2031-03-11 |
| Phase | Phase 3 |
What is known before NCT07544654 opens enrollment
NCT07544654 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT07544654 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07544654 about?
NCT07544654 is a clinical study titled "DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy". 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) ...
What is the current status of trial NCT07544654?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 390 participants. The study started on 2026-07-07. Estimated completion is 2031-03-11.
What interventions are being tested in trial NCT07544654?
The interventions under investigation include: Carboplatin (DRUG), Etoposide (DRUG), Obrixtamig (DRUG), Ventana DLL3 RxDx assay (DEVICE).
Who is sponsoring clinical trial NCT07544654?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07544654's enrollment target sits among peer trials
390 968th of 2000 higher than 1,029 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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