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Clinical Trials in the USA / NCT07544654
Recruiting Phase 3

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

NCT07544654 · tracked via the Priya Life Science USA tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 3
Started
2026-07-10
Last updated
2026-09-15

Condition(s) studied

Extrapulmonary Neuroendocrine Cancer (epNEC)

Investigational drug(s) / intervention(s)

ObrixtamigCarboplatinEtoposideVentana DLL3 RxDx assay

Obrixtamig: Obrixtamig

Carboplatin: Carboplatin

Etoposide: Etoposide

Ventana DLL3 RxDx assay: Ventana DLL3 RxDx assay

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (167)

FacilityCityRegionStatus
Mayo Clinic Scottsdale Arizona Not Yet Recruiting
City of Hope-Duarte-56419 Duarte California Recruiting
University of California San Francisco San Francisco California Not Yet Recruiting
University of California Los Angeles Santa Monica California Not Yet Recruiting
Mayo Clinic - Florida Jacksonville Florida Not Yet Recruiting
Emory University Atlanta Georgia Recruiting
The University of Chicago Medical Center Chicago Illinois Not Yet Recruiting
The Skip Viragh Outpatient Cancer Research Building Baltimore Maryland Not Yet Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Not Yet Recruiting
Mayo Clinic, Rochester Rochester Minnesota Not Yet Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Memorial Sloan-Kettering Cancer Center New York New York Not Yet Recruiting
The Ohio State University Wexner Medical Center Columbus Ohio Not Yet Recruiting
University of Pittsburgh Medical Center Pittsburgh Pennsylvania Not Yet Recruiting
University of Tennessee Knoxville Tennessee Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
Vanderbilt-Ingram Cancer Center Nashville Tennessee Not Yet Recruiting
Baylor University Medical Center Dallas Texas Not Yet Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Not Yet Recruiting
Huntsman Cancer Institute Salt Lake City Utah Not Yet Recruiting
Fred Hutchinson Cancer Research Center Seattle Washington 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 Not Yet Recruiting
Flinders Medical Centre Bedford Park South Australia Recruiting
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting
Fiona Stanley Hospital Murdoch Western 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

+ 127 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07544654 on ClinicalTrials.gov ↗ ← All trials in the USA