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RECRUITING

NCT07544654

PHASE3

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

390

Start Date

2026-07-10

Completion Date

2029-12-13

Last Updated

2026-10-28

Healthy Volunteers

Conditions

Extrapulmonary Neuroendocrine Cancer (epNEC)

Interventions

DRUG

Obrixtamig

DRUG

Carboplatin

DRUG

Etoposide

DEVICE

Ventana DLL3 RxDx assay

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.

Locations (168)

Mayo Clinic

Scottsdale, Arizona, United States

City of Hope-Duarte-56419

Duarte, California, United States

University of California San Francisco

San Francisco, California, United States

University of California Los Angeles

Santa Monica, California, United States

Mayo Clinic - Florida

Jacksonville, Florida, United States

Emory University

Atlanta, Georgia, United States

The University of Chicago Medical Center

Chicago, Illinois, United States

The Skip Viragh Outpatient Cancer Research Building

Baltimore, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic, Rochester

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

University of Tennessee

Knoxville, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Baylor University Medical Center

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Centro Medico Reumatologico - OMI

CABA, Argentina

Hospital Britanico de Buenos Aires

CABA, Argentina

Clinica Privada Independencia

Munro, Argentina

Sanatorio Parque S.A.

Rosario, Argentina

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Medical University of Graz

Graz, Austria

Medical University of Vienna

Vienna, Austria

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

UZ Leuven

Leuven, Belgium

Centre Hospitalier Universitaire de Liège

Liège, Belgium

Hospital de Amor

Barretos, Brazil

Instituto D'Or de Pesquisa E Ensino - Pe

Recife, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, Brazil

ICESP - Instituto do Cancer do Estado de Sao Paulo

São Paulo, Brazil

A.C. Camargo

São Paulo, Brazil

Arthur J. E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Instituto Oncologico FALP

Providencia, Chile

Bradford Hill- Centro de Investigacion Clinica

Recoleta, Chile

Clinica Alemana de Santiago S.A.

Santiago, Chile

Beijing Cancer Hospital

Beijing, China

Beijing GoBroad Hospital

Beijing, China

The First Hospital of Jilin University

Changchun, China

Xiangya Hospital, Central South University

Changsha, China

Hunan Province Tumor Hospital

Changsha, China

Sichuan Cancer Hospital

Chengdu, China

West China Hospital, Sichuan University

Chengdu, China

Chongqing University Affiliated Cancer Hospital

Chongqing, China

Fujian Cancer Hospital

Fuzhou, China

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, China

Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

Qilu Hospital, Shangdong University

Jinan, China

Shandong Cancer Hospital

Jinan, China

Linyi Cancer Hospital

Linyi, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, China

The Affiliated Cancer Hospital, Guangxi Medical University

Nanning, China

Shanghai General Hospital

Shanghai, China

Hubei Cancer Hospital

Wuhan, China

First Affiliated Hospital of Xi'an JiaoTong University

Xi'an, China

First Affiliated Hospital of Xiamen University

Xiamen, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Masaryk Memorial Cancer Institute

Brno, Czechia

University Hospital Hradec Kralove (FNHK)

Hradec Králové, Czechia

Aarhus University Hospital

Aarhus N, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense University Hospital

Odense C, Denmark

Helsinki University Hospital

Helsinki, Finland

KYS Sädesairaala

Kuopio, Finland

Tampere University Hospital

Tampere, Finland

Turku University Hospital / TYKS

Turku, Finland

Hopital Beaujon

Clichy, France

HOP François Mitterrand

Dijon, France

Hôpital Edouard Herriot

Lyon, France

INS Paoli-Calmettes

Marseille, France

HOP Haut-Leveque

Pessac, France

CTR Eugène Marquis

Rennes, France

Hôpital Rangueil - CHU de Toulouse

Toulouse, France

Institut Gustave Roussy

Villejuif, France

DRK Kliniken Berlin Köpenick

Berlin, Germany

Universitätsklinikum Bonn AöR

Bonn, Germany

Universitätsklinikum Köln (AöR)

Cologne, Germany

Technische Universität Dresden

Dresden, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Asklepios Klinik St Georg

Hamburg, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Germany

Westfälische Wilhelms-Universität Münster

Münster, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Universitätsklinikum Würzburg AÖR

Würzburg, Germany

Prince of Wales Hospital-Hong Kong-20715

Hong Kong, Hong Kong

Queen Mary Hospital

Hong Kong, Hong Kong

Soroka Univ. Medical Center

Beersheba, Israel

And 68 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (168)