Extrapulmonary Neuroendocrine Cancer (epNEC)Phase 3NCT07544654
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 3 study testing Obrixtamig, Carboplatin and Etoposide in people with Extrapulmonary Neuroendocrine Cancer (epNEC), run by Boehringer Ingelheim at 166 sites in 29 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extrapulmonary Neuroendocrine Cancer (epNEC)
- What is being tested?
- Obrixtamig, Carboplatin and Etoposide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 166 sitesin 29 countries
- Study dates
- 10 Jul 2026to 13 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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.
Who cannot join
- 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)
- 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.
Trial locations and contacts
166 sites in 29 countries. Contact the study team or a site near you to ask about taking part.
166 sites in 29 countries
China22 sites, 22 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, 100142
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Beijing GoBroad Hospital
Beijing, 102200
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
The First Hospital of Jilin University
Changchun, 130021
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Xiangya Hospital, Central South University
Changsha, 410008
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Hunan Province Tumor Hospital
Changsha, 410013
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Sichuan Cancer Hospital
Chengdu, 610041
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, 610041
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Chongqing University Affiliated Cancer Hospital
Chongqing, 400000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, 350014
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, 510080
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, 150081
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Qilu Hospital, Shangdong University
Jinan, 250012
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shandong Cancer Hospital
Jinan, 250117
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Linyi Cancer Hospital
Linyi, 276034
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, 471003
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The Affiliated Cancer Hospital, Guangxi Medical University
Nanning, 530021
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shanghai General Hospital
Shanghai, 200080
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Hubei Cancer Hospital
Wuhan, 430000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
First Affiliated Hospital of Xi'an JiaoTong University
Xi'an, 710061
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
First Affiliated Hospital of Xiamen University
Xiamen, 361003
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
United States21 sites, 21 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
The Skip Viragh Outpatient Cancer Research Building
Baltimore, Maryland, 21287
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
The University of Chicago Medical Center
Chicago, Illinois, 60637
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43221
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Baylor University Medical Center
Dallas, Texas, 75246
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
City of Hope-Duarte-56419
Duarte, California, 91010
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Mayo Clinic - Florida
Jacksonville, Florida, 32224
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of Tennessee
Knoxville, Tennessee, 37920
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, 10022
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
University of California San Francisco
San Francisco, California, 94158
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
University of California Los Angeles
Santa Monica, California, 90404
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Mayo Clinic
Scottsdale, Arizona, 85259
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63108
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Germany13 sites, 13 recruiting
- Recruiting
DRK Kliniken Berlin Köpenick
Berlin, 12559
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Universitätsklinikum Bonn AöR
Bonn, 53127
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Universitätsklinikum Köln (AöR)
Cologne, 50937
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Technische Universität Dresden
Dresden, 01307
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Universitätsklinikum Erlangen
Erlangen, 91054
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Asklepios Klinik St Georg
Hamburg, 20099
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69120
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Westfälische Wilhelms-Universität Münster
Münster, 48149
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Tübingen
Tübingen, 72076
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Universitätsklinikum Würzburg AÖR
Würzburg, 97078
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Japan13 sites, 13 recruiting
- Not yet recruiting
Aichi Cancer Center Hospital
Aichi, Nagoya, 464-8681
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Shikoku Cancer Center
Ehime, Matsuyama, 791-0280
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Kanazawa University Hospital
Ishikawa, Kanazawa, 920-8641
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Kanagawa Cancer Center
Kanagawa, Yokohama, 241-8515
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Tohoku University Hospital
Miyagi, Sendai, 980-8574
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Okayama University Hospital
Okayama, Okayama, 700-8558
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Osaka International Cancer Institute
Osaka, Osaka, 541-8567
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Shizuoka Cancer Center
Shizuoka, Sunto-gun, 411-8777
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Spain10 sites, 10 recruiting
- Not yet recruiting
Institut Català d'Oncologia de Badalona
Badalona, 8916
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Regional Universitario de Malaga
Málaga, 29010
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario de Navarra
Pamplona, 31008
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Virgen del Rocio
Seville, 41013
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Clinico De Valencia (INCLIVA)
Valencia, 46010
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
France8 sites, 8 recruiting
- Recruiting
Hôpital Beaujon
Clichy, 92110
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
HOP François Mitterrand
Dijon, 21000
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
Hôpital Edouard Herriot
Lyon, 69437
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
INS Paoli-Calmettes
Marseille, 13009
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
HOP Haut-Lévêque
Pessac, 33604
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
CTR Eugène Marquis
Rennes, 35042
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
Hôpital Rangueil - CHU de Toulouse
Toulouse, 31059
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
Institut Gustave Roussy
Villejuif, 94800
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Italy7 sites, 7 recruiting
- Not yet recruiting
A. O. Universitaria Careggi
Florence, 50134
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
Istituto Europeo di Oncologia
Milan, 20141
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Naples, 80131
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90129
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Fondazione Policlinico Universitario Campus Bio-medico
Roma, 00128
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
Centro Ricerche Cliniche di Verona S.r.l.
Verona, 37134
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Brazil5 sites, 5 recruiting
- Recruiting
Hospital de Amor
Barretos, 14784-400
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Not yet recruiting
Instituto D'Or de Pesquisa E Ensino - Pe
Recife, 50070-480
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
ICESP - Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246-000
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Not yet recruiting
A.C. Camargo
São Paulo, 01509-010
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Mexico5 sites, 5 recruiting
- Not yet recruiting
Centro Medico Nacional de Occidente/ Centro De Investigacion Biomedica De Occidente
Guadalajara, Jalisco, 44329
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Centro Oncologico Personalizado
México, 06760
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Health Pharma Professional Research S.A. de C.V.
Mexico City, 03100
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Recruiting
Centro Oncologico Estatal ISSEMYM
Toluca, 50180
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Instituto Jaliciense de Cancerología
Zapopan, 45060
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Portugal5 sites, 5 recruiting
- Not yet recruiting
IPO Lisboa Francisco Gentil, EPE
Lisbon, 1099-023
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Recruiting
Hospital Lusiadas Lisboa
Lisbon, 1500-458
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Not yet recruiting
Unidade Local de Saúde Santa Maria
Lisbon, 1699-035
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Not yet recruiting
Hospital CUF Porto
Porto, 4100-180
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Recruiting
IPO Porto Francisco Gentil, EPE
Porto, 4200-072
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
Argentina4 sites, 4 recruiting
- Recruiting
Centro Medico Reumatologico - OMI
CABA, 1015
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Hospital Britanico de Buenos Aires
CABA, 1280AEB
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Clinica Privada Independencia
Munro, B1605
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Sanatorio Parque S.A.
Rosario, S2000DSV
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Australia4 sites, 4 recruiting
- Recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5042
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Belgium4 sites, 4 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Recruiting
UZ Leuven
Leuven, 3000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Recruiting
Centre Hospitalier Universitaire de Liège
Liège, 4000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Finland4 sites, 4 recruiting
- Recruiting
Helsinki University Hospital
Helsinki, 00290
Boehringer Ingelheim, 0800918118, suomi@bitrialsupport.com
- Recruiting
KYS Sädesairaala
Kuopio, 70029
Boehringer Ingelheim, 0800918118, suomi@bitrialsupport.com
- Not yet recruiting
Tampere University Hospital
Tampere, 33520
Boehringer Ingelheim, 0800918118, suomi@bitrialsupport.com
- Not yet recruiting
Turku University Hospital / TYKS
Turku, 20520
Boehringer Ingelheim, 0800918118, suomi@bitrialsupport.com
Israel4 sites, 4 recruiting
- Not yet recruiting
Soroka Univ. Medical Center
Beersheba, 84101
Boehringer Ingelheim, 1809388162, israel@bitrialsupport.com
- Not yet recruiting
Rambam Health Care Campus
Haifa, 3109601
Boehringer Ingelheim, 1809388162, israel@bitrialsupport.com
- Not yet recruiting
Hadassah Medical Center, Ein-Karem
Jerusalem, 9112001
Boehringer Ingelheim, 1809388162, israel@bitrialsupport.com
- Not yet recruiting
Sourasky Medical Center
Tel Aviv, 6093246
Boehringer Ingelheim, 1809388162, israel@bitrialsupport.com
Netherlands4 sites, 4 recruiting
- Not yet recruiting
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
Amsterdam, 1066CX
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
- Not yet recruiting
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
- Not yet recruiting
Maastricht University Medisch Centrum
Maastricht, 6229 HX
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
- Not yet recruiting
Erasmus Medisch Centrum
Rotterdam, 3015 GD
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
Norway4 sites, 4 recruiting
- Recruiting
Haukeland Universitetssykehus
Bergen, 5021
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
- Not yet recruiting
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, N-0379
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
- Recruiting
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, 4011
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
- Not yet recruiting
St. Olavs Hospital, Universitetssykehuset i Trondheim
Trondheim, 7030
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Severance Hospital
Seoul, 03722
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Asan Medical Center
Seoul, 05505
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Samsung Medical Center
Seoul, 06351
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Chile3 sites, 3 recruiting
- Not yet recruiting
Instituto Oncologico FALP
Providencia
Boehringer Ingelheim, 800392345, chile@bitrialsupport.com
- Not yet recruiting
Bradford Hill- Centro de Investigacion Clinica
Recoleta, 8420383
Boehringer Ingelheim, 800392345, chile@bitrialsupport.com
- Not yet recruiting
Clinica Alemana de Santiago S.A.
Santiago, 7650568
Boehringer Ingelheim, 800392345, chile@bitrialsupport.com
Denmark3 sites, 3 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
Boehringer Ingelheim, 80711822, danmark@bitrialsupport.com
- Not yet recruiting
Rigshospitalet
Copenhagen, 2100
Boehringer Ingelheim, 80711822, danmark@bitrialsupport.com
- Not yet recruiting
Odense University Hospital
Odense C, 5000
Boehringer Ingelheim, 80711822, danmark@bitrialsupport.com
Sweden3 sites, 3 recruiting
- Not yet recruiting
Sahlgrenska Universitetsjukhuset
Gothenburg, 41345
Boehringer Ingelheim, 0200880001, sverige@bitrialsupport.com
- Recruiting
Skånes universitetssjukhus
Lund, 22185
Boehringer Ingelheim, 0200880001, sverige@bitrialsupport.com
- Recruiting
Uppsala University Hospital
Uppsala, 751 85
Boehringer Ingelheim, 0200880001, sverige@bitrialsupport.com
Taiwan3 sites, 3 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, 70403
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
Taipei Veterans General Hospital
Taipei, 112201
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
Chang Gung Memorial Hospital, Linkou
Taoyuan City, 333
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
Western General Hospital
Edinburgh, EH4 2XU
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
The Christie Hospital
Manchester, M20 4BX
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Austria2 sites, 2 recruiting
- Not yet recruiting
Medical University of Graz
Graz, 8036
Boehringer Ingelheim, 0800017900, oesterreich@bitrialsupport.com
- Not yet recruiting
Medical University of Vienna
Vienna, 1090
Boehringer Ingelheim, 0800017900, oesterreich@bitrialsupport.com
Czechia2 sites, 2 recruiting
- Not yet recruiting
Masaryk Memorial Cancer Institute
Brno, 65653
Boehringer Ingelheim, 800142046, cesko@bitrialsupport.com
- Not yet recruiting
University Hospital Hradec Kralove (FNHK)
Hradec Králové, 50005
Boehringer Ingelheim, 800142046, cesko@bitrialsupport.com
Hong Kong2 sites, 2 recruiting
- Recruiting
Prince of Wales Hospital-Hong Kong-20715
Hong Kong, 999077
Boehringer Ingelheim, 800965365, hongkong@bitrialsupport.com
- Recruiting
Queen Mary Hospital
Hong Kong, 999077
Boehringer Ingelheim, 800965365, hongkong@bitrialsupport.com
Poland2 sites, 2 recruiting
- Not yet recruiting
Medical University Gdansk
Gdansk, 80-214
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Not yet recruiting
Silesian Medical University in Katowice
Katowice, 40514
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
New Zealand1 site, 1 recruiting
- Not yet recruiting
Auckland City Hospital
Grafton / Auckland, 1023
Boehringer Ingelheim, 0800440725, newzealand@bitrialsupport.com
About this study
Official title: 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
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.
- Being tested
- Obrixtamig, Carboplatin, Etoposide, Ventana DLL3 RxDx assay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObrixtamigDrug
Obrixtamig
CarboplatinDrug
Carboplatin
EtoposideDrug
Etoposide
Ventana DLL3 RxDx assayDevice
Ventana DLL3 RxDx assay
| Study group | Role | What they receive |
|---|---|---|
| Obrixtamig + carboplatin + etoposide | Experimental | Treatment arm Receives: Drug: Obrixtamig; Drug: Carboplatin; Drug: Etoposide; Device: Ventana DLL3 RxDx assay |
| Carboplatin + etoposide | Active comparator | Control arm Receives: Drug: Carboplatin; Drug: Etoposide; Device: Ventana DLL3 RxDx assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
defined as the time from randomisation until death from any cause
Measured: Up to 38 months
Secondary outcomes (9)
Progression-free survival (PFS)
defined as the time from randomisation until the earliest date of disease progression according to RECIST 1.1 based on investigator assessments or death from any cause, whichever occurs first
Measured: Up to 38 months
Change from baseline to Week 19 in the physical functioning domain of the EORTC QLQ-C30
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) includes 1 global health status/QoL scale, 5 functional scales, 3 symptoms scales and 6 single items to assess dyspnea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties.
Each score 0-100. Global health status higher = better, functional scale higher = better, symptom scale higher = worse
Measured: At baseline, up to week 19
Objective response (OR)
defined as a best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 (based on investigator assessments) from randomisation until the earliest date of disease progression, death, last evaluable tumour assessment before the start of next line of anti-cancer treatment, loss to follow-up, or withdrawal of consent
Measured: Up to 38 months
Duration of response (DoR)
defined as the time from the first documented OR according to RECIST 1.1 until the earliest date of disease progression or death among patients with objective response based on investigator assessments
Measured: Up to 38 months
Disease control (DC)
defined as best overall response of complete response (CR) or partial response (PR) or stable disease (SD) where best overall response is defined according to RECIST 1.1 based on investigator assessments from randomisation until the earliest of disease progression, death or last evaluable tumour assessment before start of next line of anti-cancer treatment, loss to follow-up or withdrawal of consent
Measured: Up to 38 months
Occurrence of treatment-emergent Grade 3 or greater Cytokine release syndrome (CRS)
Measured: Up to 38 months
Occurrence of treatment-emergent Grade 3 or greater Immune cell associated neurotoxicity syndrome (ICANS)
Measured: Up to 38 months
Occurrence of treatment-emergent adverse events (AEs) leading to permanent discontinuation of trial medication during the on-treatment period
Measured: Up to 38 months
Occurrence of treatment-emergent AEs leading to dose modification of trial medication (i.e. dose interruption, dose delay, dose reduction)
Measured: Up to 38 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start10 Jul 2026
- Primary completion13 Dec 2029 (estimated)
- Study completion13 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extrapulmonary Neuroendocrine Cancer (epNEC)Studies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544654
- Sponsor's protocol ID
- 1438-0011
- Other IDs
- 2025-523869-22-00, U1111-1328-6623, 2025
- Status last verified
- Oct 2026
- First submitted
- 16 Apr 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07544654
- Acronym / sponsor ID
- 1438-0011
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 13 Dec 2029 (estimated)
- Study completion
- 13 Dec 2029 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obrixtamig + carboplatin + etoposide | Experimental | Drug: Obrixtamig, Drug: Carboplatin, Drug: Etoposide, Device: Ventana DLL3 RxDx assayTreatment arm |
| Carboplatin + etoposide | Active comparator | Drug: Carboplatin, Drug: Etoposide, Device: Ventana DLL3 RxDx assayControl arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObrixtamigObrixtamig | Drug | Obrixtamig + carboplatin + etoposide |
| CarboplatinCarboplatin | Drug | Carboplatin + etoposide, Obrixtamig + carboplatin + etoposide |
| EtoposideEtoposide | Drug | Carboplatin + etoposide, Obrixtamig + carboplatin + etoposide |
| Ventana DLL3 RxDx assayVentana DLL3 RxDx assay | Device | Carboplatin + etoposide, Obrixtamig + carboplatin + etoposide |
Primary outcome
Overall survival (OS)
Time frame: Up to 38 months
defined as the time from randomisation until death from any cause
9 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 38 months
Change from baseline to Week 19 in the physical functioning domain of the EORTC QLQ-C30
Time frame: At baseline, up to week 19
Objective response (OR)
Time frame: Up to 38 months
Duration of response (DoR)
Time frame: Up to 38 months
Disease control (DC)
Time frame: Up to 38 months
Occurrence of treatment-emergent Grade 3 or greater Cytokine release syndrome (CRS)
Time frame: Up to 38 months
Occurrence of treatment-emergent Grade 3 or greater Immune cell associated neurotoxicity syndrome (ICANS)
Time frame: Up to 38 months
Occurrence of treatment-emergent adverse events (AEs) leading to permanent discontinuation of trial medication during the on-treatment period
Time frame: Up to 38 months
Occurrence of treatment-emergent AEs leading to dose modification of trial medication (i.e. dose interruption, dose delay, dose reduction)
Time frame: Up to 38 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Extrapulmonary Neuroendocrine Cancer (epNEC)
RecruitingPhase 1/2
Study of [212Pb]Pb-DOTAM-MAM279 ([212Pb]Pb-MP0712) in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors
Large Cell Neuroendocrine Carcinoma, Large Cell Pulmonary Neuroendocrine Carcinoma of the Lung (LCNEC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
166 sites in 29 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Obrixtamig, Carboplatin and Etoposide in people with Extrapulmonary Neuroendocrine Cancer (epNEC), run by Boehringer Ingelheim at 166 sites in 29 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 166 sites in China, United States, Germany, Japan, Spain and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-012, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Up to 38 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.