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 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
3 other identifiers
interventional
390
28 countries
159
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2026
Typical duration for phase_3
159 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2026
CompletedFirst Posted
Study publicly available on registry
April 22, 2026
CompletedStudy Start
First participant enrolled
June 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2029
Study Completion
Last participant's last visit for all outcomes
December 13, 2029
May 6, 2026
May 1, 2026
3.5 years
April 16, 2026
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
defined as the time from randomisation until death from any cause
Up to 38 months
Secondary Outcomes (9)
Progression-free survival (PFS)
Up to 38 months
Change from baseline to Week 19 in the physical functioning domain of the EORTC QLQ-C30
At baseline, up to week 19
Objective response (OR)
Up to 38 months
Duration of response (DoR)
Up to 38 months
Disease control (DC)
Up to 38 months
- +4 more secondary outcomes
Study Arms (2)
Obrixtamig + carboplatin + etoposide
EXPERIMENTALTreatment arm
Carboplatin + etoposide
ACTIVE COMPARATORControl arm
Interventions
Ventana DLL3 RxDx assay
Eligibility Criteria
You may qualify if:
- 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)
- 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
- 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
- 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
- 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)
- 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
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
You may not qualify if:
- Presence of leptomeningeal disease and/or carcinomatous meningitis
- Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma
- Patients with neuroendocrine prostate cancer
- Patients with well-differentiated neuroendocrine tumours of any grade according to the world health organization (WHO) classification, 5th edition
- Patients with a history of well differentiated Neuroendocrine tumour (NET) tumour that transformed into poorly differentiated Neuroendocrine carcinoma (NEC)
- Previous treatment with obrixtamig or other DLL3-targeting therapies (e.g. T-cell engager (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (163)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
City of Hope-Duarte-56419
Duarte, California, 91010, United States
Stanford Cancer Center
Palo Alto, California, 94304, United States
University of California San Francisco
San Francisco, California, 94158, United States
University of California Los Angeles
Santa Monica, California, 90404, United States
Mayo Clinic - Florida
Jacksonville, Florida, 32224, United States
Emory University
Atlanta, Georgia, 30322, United States
The Skip Viragh Outpatient Cancer Research Building
Baltimore, Maryland, 21287, United States
Mayo Clinic, Rochester
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10022, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
University of Tennessee
Knoxville, Tennessee, 37920, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Centro Medico Reumatologico - OMI
CABA, 1015, Argentina
Hospital Britanico de Buenos Aires
CABA, 1280AEB, Argentina
Clinica Privada Independencia
Munro, B1605, Argentina
Sanatorio Parque S.A.
Rosario, S2000DSV, Argentina
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Medical University Graz
Graz, 8036, Austria
AKH - Medical University of Vienna
Vienna, 1090, Austria
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Edegem - UNIV UZ Antwerpen
Edegem, 2650, Belgium
UZ Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liège
Liège, 4000, Belgium
Hospital de Amor
Barretos, 14784-400, Brazil
Instituto D'Or de Pesquisa E Ensino - Pe
Recife, 50070-480, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000, Brazil
ICESP - Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246-000, Brazil
A.C. Camargo
São Paulo, 01509-010, Brazil
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Instituto Oncológico FALP
Providencia, Chile
Bradford Hill- Centro de Investigación Clínica
Recoleta, 8420383, Chile
Clínica Alemana de Santiago S.A.
Santiago, 7650568, Chile
Beijing Cancer Hospital
Beijing, 100142, China
Beijing GoBroad Hospital
Beijing, 102200, China
The First Hospital of Jilin University
Changchun, 130021, China
Xiangya Hospital, Central South University
Changsha, 410008, China
Hunan Province Tumor Hospital
Changsha, 410013, China
Sichuan Cancer Hospital
Chengdu, 610041, China
West China Hospital, Sichuan University
Chengdu, 610041, China
Chongqing University Affiliated Cancer Hospital
Chongqing, 400000, China
Fujian Cancer Hospital
Fuzhou, 350014, China
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, 510080, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Qilu Hospital, Shangdong University
Jinan, 250012, China
Shandong Cancer Hospital
Jinan, 250117, China
Linyi Cancer Hospital
Linyi, 276034, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, 471003, China
The Affiliated Cancer Hospital, Guangxi Medical University
Nanning, 530021, China
Shanghai General Hospital
Shanghai, 200080, China
Hubei Cancer Hospital
Wuhan, 430000, China
First Affiliated Hospital of Xi'an JiaoTong University
Xi'an, 710061, China
First Affiliated Hospital of Xiamen University
Xiamen, 361003, China
Henan Cancer Hospital
Zhengzhou, 450003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052, China
Masaryk Memorial Cancer Institute
Brno, 65653, Czechia
University Hospital Hradec Kralove (FNHK)
Hradec Králové, 50005, Czechia
Aarhus University Hospital
Aarhus N, 8200, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Odense University Hospital
Odense C, 5000, Denmark
Helsinki University Hospital
Helsinki, 00290, Finland
KYS Sädesairaala
Kuopio, 70029, Finland
Tampere University Hospital
Tampere, 33520, Finland
Turku University Hospital / TYKS
Turku, 20520, Finland
Hôpital Beaujon
Clichy, 92110, France
HOP François Mitterrand
Dijon, 21000, France
Hôpital Edouard Herriot
Lyon, 69437, France
INS Paoli-Calmettes
Marseille, 13009, France
HOP Haut-Lévêque
Pessac, 33604, France
CTR Eugène Marquis
Rennes, 35042, France
Hôpital Rangueil - CHU de Toulouse
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94800, France
DRK Kliniken Berlin Köpenick
Berlin, 12559, Germany
Universitätsklinikum Bonn AöR
Bonn, 53127, Germany
Universitätsklinikum Köln (AöR)
Cologne, 50937, Germany
Technische Universität Dresden
Dresden, 01307, Germany
Universitätsklinikum Erlangen
Erlangen, 91054, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Asklepios Klinik St Georg
Hamburg, 20099, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Westfälische Wilhelms-Universität Münster
Münster, 48149, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Universitätsklinikum Würzburg AÖR
Würzburg, 97078, Germany
Prince of Wales Hospital-Hong Kong-20715
Hong Kong, 999077, Hong Kong
Queen Mary Hospital
Hong Kong, 999077, Hong Kong
Soroka Univ. Medical Center
Beersheba, 84101, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Hadassah Medical Center, Ein-Karem
Jerusalem, 9112001, Israel
Sourasky Medical Center
Tel Aviv, 6093246, Israel
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Bari, 70124, Italy
A. O. Universitaria Careggi
Florence, 50134, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Naples, 80131, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90129, Italy
Fondazione Policlinico Universitario Campus Bio-medico
Roma, 00128, Italy
Centro Ricerche Cliniche di Verona S.r.l.
Verona, 37134, Italy
Aichi Cancer Center Hospital
Aichi, Nagoya, 464-8681, Japan
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577, Japan
Shikoku Cancer Center
Ehime, Matsuyama, 791-0280, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648, Japan
Kanazawa University Hospital
Ishikawa, Kanazawa, 920-8641, Japan
Kanagawa Cancer Center
Kanagawa, Yokohama, 241-8515, Japan
Kyoto University Hospital
Kyoto, Kyoto, 606-8507, Japan
Tohoku University Hospital
Miyagi, Sendai, 980-8574, Japan
Okayama University Hospital
Okayama, Okayama, 700-8558, Japan
Osaka International Cancer Institute
Osaka, Osaka, 541-8567, Japan
Shizuoka Cancer Center
Shizuoka, Sunto-gun, 411-8777, Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045, Japan
Health Pharma Professional Research S.A. de C.V.
Mexico City, 03100, Mexico
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
Amsterdam, 1066CX, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Maastricht University Medisch Centrum
Maastricht, 6229 HX, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 CP, Netherlands
Auckland City Hospital
Grafton / Auckland, 1023, New Zealand
Haukeland Universitetssykehus
Bergen, 5021, Norway
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, N-0379, Norway
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, 4011, Norway
St. Olavs Hospital, Universitetssykehuset i Trondheim
Trondheim, 7030, Norway
Medical University Gdansk
Gdansk, 80-214, Poland
Silesian Medical University in Katowice
Katowice, 40514, Poland
IPO Lisboa Francisco Gentil, EPE
Lisbon, 1099-023, Portugal
Hospital Lusíadas Lisboa
Lisbon, 1500-458, Portugal
Unidade Local de Saúde Santa Maria
Lisbon, 1699-035, Portugal
Hospital CUF Porto
Porto, 4100-180, Portugal
IPO Porto Francisco Gentil, EPE
Porto, 4200-072, Portugal
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Institut Català d'Oncologia de Badalona
Badalona, 8916, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Regional Universitario de Málaga
Málaga, 29010, Spain
Complejo Hospitalario de Navarra
Pamplona, 31008, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital Virgen del Rocío
Seville, 41013, Spain
Hospital Clinico De Valencia (INCLIVA)
Valencia, 46010, Spain
Sahlgrenska Universitetsjukhuset
Gothenburg, 41345, Sweden
Skånes universitetssjukhus
Lund, 22185, Sweden
Uppsala University Hospital
Uppsala, 751 85, Sweden
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
Taipei Veterans General Hospital
Taipei, 112201, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan City, 333, Taiwan
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
The Christie Hospital
Manchester, M20 4BX, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2026
First Posted
April 22, 2026
Study Start (Estimated)
June 15, 2026
Primary Completion (Estimated)
December 13, 2029
Study Completion (Estimated)
December 13, 2029
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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.