DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy
Start Date
7/10/2026
Completion Date
3/11/2031
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 Criteria
Age Range: 18 years to No maximum
Interventions
Obrixtamig
Carboplatin
Etoposide
Ventana DLL3 RxDx assay
Conditions
Locations
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
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Mayo Clinic, Rochester
Rochester, Minnesota 55905
United States
Washington University School of Medicine
St Louis, Missouri 63108
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
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
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 of Graz
Graz, 8036
Austria
AKH - Medical University of Vienna
Vienna, 1090
Austria
Cliniques Universitaires Saint-Luc
Brussels, 1200
Belgium
Universitair Ziekenhuis 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 Düsseldorf
Düsseldorf, 40225
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 GD
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
Guy's Hospital
London, SE1 9RT
United Kingdom
The Christie Hospital
Manchester, M20 4BX
United Kingdom