NCT07544654From ClinicalTrials.govRecruiting

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

A Phase III, Multi-center, Open-label, Randomised, Controlled Trial of Intravenous Obrixtamig in Combination With Carboplatin and Etoposide vs. Carboplatin and Etoposide as First-line Therapy in DLL3-positive Patients With Unresectable Locally Advanced or Metastatic Extrapulmonary Neuroendocrine Carcinomas

Extrapulmonary Neuroendocrine Cancer (epNEC)

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Boehringer Ingelheim
Enrolment target: 390
Started: 10 July 2026
Main results due: 13 December 2029
Study sites: 167
Registry updated: 29 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

1. Patients with poorly differentiated unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinoma (epNEC) with Ki-67 \>20% or mitotic rate mitotic rate with number of mitoses \>20 per 2 mm2, regardless of primary site (including site of unknown origin)
2. Patients with tumours with mixed histologies are eligible only if neuroendocrine carcinoma component is predominant and represents more than 70% of the overall tumour tissue
3. No prior systemic treatment for unresectable locally advanced or metastatic epNEC (except for the completed one cycle of standard platinum + etoposide). Prior peri-operative chemotherapy or -radiation for curative intention is allowed if at least 6 months have elapsed between completion of this therapy and diagnosis of unresectable locally advanced or metastatic disease
4. Patients who have finished one cycle of standard platinum + etoposide regimen as first-line treatment (Cycle 0: etoposide with carboplatin or cisplatin, administered at a minimum dose of cisplatin 75 mg/m2 or carboplatin area under the curve (AUC) 5 and etoposide 80 mg/m2) prior to randomisation
5. Patients must comply with criteria for receiving further chemotherapy treatment as first-line standard of care (SoC) treatment within 28 days after the start of the initial chemotherapy (Cycle 0)
6. Adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status. Tumours must be positive (as defined in the diagnostic study protocol) for DLL3 expression status assessed by investigational VENTANA DLL3 (SP347) RxDx Assay
7. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
8. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF) Further inclusion criteria apply.

Exclusion Criteria:

1. Presence of leptomeningeal disease and/or carcinomatous meningitis
2. Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma
3. Patients with neuroendocrine prostate cancer
4. Patients with well-differentiated neuroendocrine tumours of any grade according to the world health organization (WHO) classification, 5th edition
5. Patients with a history of well differentiated Neuroendocrine tumour (NET) tumour that transformed into poorly differentiated Neuroendocrine carcinoma (NEC)
6. Previous treatment with obrixtamig or other DLL3-targeting therapies (e.g. T-cell engager (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)
7. Previous treatment with anti-PD-1 or programmed death ligand 1 (PD-L1) therapies during the one cycle of standard platinum + etoposide first-line chemotherapy (Cycle 0)
8. Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or grade prior to Cycle 0. Participants with alopecia any grade, CTCAE ≤Grade 2 asthenia/fatigue, amenorrhea/menstrual disorders any grade, CTCAE ≤Grade 2 peripheral neuropathy, and/or CTCAE ≤Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per Investigator judgement may be eligible Further exclusion criteria apply.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(167)

Mayo Clinic
Scottsdale, Arizona, United States
Not yet recruiting
City of Hope-Duarte-56419
Duarte, California, United States
Recruiting
University of California San Francisco
San Francisco, California, United States
Not yet recruiting
University of California Los Angeles
Santa Monica, California, United States
Not yet recruiting
Mayo Clinic - Florida
Jacksonville, Florida, United States
Not yet recruiting
Emory University
Atlanta, Georgia, United States
Recruiting
The University of Chicago Medical Center
Chicago, Illinois, United States
Not yet recruiting
The Skip Viragh Outpatient Cancer Research Building
Baltimore, Maryland, United States
Not yet recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Not yet recruiting
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Not yet recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Not yet recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Not yet recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Not yet recruiting
University of Tennessee
Knoxville, Tennessee, United States
Recruiting
SCRI Oncology Partners
Nashville, Tennessee, United States
Recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Not yet recruiting
Baylor University Medical Center
Dallas, Texas, United States
Not yet recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Not yet recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Not yet recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Not yet recruiting
Centro Medico Reumatologico - OMI
CABA, Argentina
Recruiting
Hospital Britanico de Buenos Aires
CABA, Argentina
Recruiting
Clinica Privada Independencia
Munro, Argentina
Recruiting
Sanatorio Parque S.A.
Rosario, Argentina
Recruiting
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Not yet recruiting
Flinders Medical Centre
Bedford Park, South Australia, Australia
Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Recruiting
Medical University of Graz
Graz, Austria
Not yet recruiting
Medical University of Vienna
Vienna, Austria
Not yet recruiting
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Recruiting
UZ Leuven
Leuven, Belgium
Recruiting
Centre Hospitalier Universitaire de Liège
Liège, Belgium
Recruiting
Hospital de Amor
Barretos, Brazil
Recruiting
Instituto D'Or de Pesquisa E Ensino - Pe
Recife, Brazil
Not yet recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, Brazil
Recruiting
ICESP - Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
Not yet recruiting
A.C. Camargo
São Paulo, Brazil
Not yet recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Recruiting
Instituto Oncologico FALP
Providencia, Chile
Not yet recruiting
Bradford Hill- Centro de Investigacion Clinica
Recoleta, Chile
Not yet recruiting
Clinica Alemana de Santiago S.A.
Santiago, Chile
Not yet recruiting
Beijing Cancer Hospital
Beijing, China
Recruiting
Beijing GoBroad Hospital
Beijing, China
Recruiting
The First Hospital of Jilin University
Changchun, China
Not yet recruiting
Xiangya Hospital, Central South University
Changsha, China
Not yet recruiting
Hunan Province Tumor Hospital
Changsha, China
Not yet recruiting
Sichuan Cancer Hospital
Chengdu, China
Recruiting
West China Hospital, Sichuan University
Chengdu, China
Recruiting
Chongqing University Affiliated Cancer Hospital
Chongqing, China
Recruiting
Fujian Cancer Hospital
Fuzhou, China
Not yet recruiting
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, China
Recruiting
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, China
Recruiting
Harbin Medical University Cancer Hospital
Harbin, China
Recruiting
Qilu Hospital, Shangdong University
Jinan, China
Recruiting
Shandong Cancer Hospital
Jinan, China
Recruiting
Linyi Cancer Hospital
Linyi, China
Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
Recruiting

Showing 60 of 167 sites — filter to narrow it down. 60 of the 167 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07544654. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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