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RECRUITING

NCT07472517

PHASE3

DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemoimmunotherapy

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

This study is open to adults with advanced small cell lung cancer (SCLC). The purpose of this study is to find out if a study medicine called obrixtamig plus standard treatment (atezolizumab, carboplatin, and etoposide) improves survival when compared to standard treatment 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 DLL3. Participants are put into 2 groups randomly, which means by chance. One group receives obrixtamig and standard treatment. The other group receives standard treatment without obrixtamig. All treatments are given as infusions into a vein. Participants are in the study for up to 3 years. During this time, they visit the study site regularly. Participants in the group receiving obrixtamig stay overnight at the study site following the first 2 obrixtamig treatments. At the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Official title: DAREON ® -Lung-1: A Phase III Multi-center, Open-label, Randomised Trial of Intravenous Obrixtamig in Combination With Atezolizumab, Carboplatin, and Etoposide vs. Atezolizumab, Carboplatin, and Etoposide as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

670

Start Date

2026-04-13

Completion Date

2029-07-30

Last Updated

2026-10-28

Healthy Volunteers

Conditions

Small Cell Lung Cancer (SCLC)Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Interventions

DRUG

obrixtamig

DRUG

atezolizumab

DRUG

carboplatin

DRUG

etoposide

Inclusion Criteria : 1. Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC) 2. Patients without any previous systemic anti-cancer treatment for ES-SCLC. Patients who received previous systemic anti-cancer treatment during limited stage are eligible if the treatment has been completed more than 6 months before the diagnosis of ES-SCLC. 3. 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 and other biomarkers. The central laboratory investigational VENTANA DLL3 (SP347) RxDx test result must be available prior to randomisation. 4. Patients with asymptomatic brain metastasis are eligible if they meet one of the following criteria: * Treatment for brain metastases (e.g. whole brain radiation therapy, stereotactic radiotherapy, or radiosurgery) completed at least 7 days prior to randomisation and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 7 days prior to randomisation * Untreated brain metastases that do not require treatment and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 28 days prior to randomisation 5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 6. Eligible for continuing carboplatin + etoposide + atezolizumab regimen as first-line Standard of care (SoC) treatment within 28 days after the start of the initial cycle of standard therapy 7. Eligible to receive treatment with full dose of atezolizumab, carboplatin, and etoposide as first-line SoC treatment, in accordance with the approved Summary of Product Characteristics if provided centrally or approved local product label if provided by the trial site Further inclusion criteria apply. Exclusion Criteria : 1. Presence of leptomeningeal disease and/or carcinomatous meningitis 2. Previous treatment targeting DLL3 (e.g. T cell engagers (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals) 3. Radiotherapy of any anatomical site within 7 days prior to randomisation 4. Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline. Patients 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 prior to randomisation, per investigator judgment may be eligible. Note: Patients who developed toxicity from the cycle of standard therapy received prior to randomisation are eligible if adequate organ function is ensured as described 5. Patient with active autoimmune disease or a documented history of autoimmune disease that requires systemic treatment (e.g. glucocorticoids or immunosuppressive drugs). Patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy, patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen may be included if in the opinion of the investigator it is appropriate and safe to do so. Further exclusion criteria apply.

Locations (243)

Infirmary Cancer Care

Mobile, Alabama, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Bioresearch Partner - Hialeah Hospital

Hialeah, Florida, United States

Emory University

Atlanta, Georgia, United States

Norton Cancer Institute, Downtown

Louisville, Kentucky, United States

Pikeville Medical Center

Pikeville, Kentucky, United States

Epic Medical Research - Monroe

Monroe, Louisiana, United States

Epic Medical Research - Shreveport

Shreveport, Louisiana, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

Veterans Affairs Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

HCA MidAmerica Division, Inc.

Kansas City, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Cape Fear Valley Cancer Center

Fayetteville, North Carolina, United States

AHN Cancer Institute - Allegheny General

Pittsburgh, Pennsylvania, United States

Baptist Cancer Center - Memphis

Memphis, Tennessee, United States

University of Wisconsin

Madison, Wisconsin, United States

Hospital Britanico de Buenos Aires

CABA, Argentina

Clinica Adventista Belgrano

CABA, Argentina

Clinica Privada Independencia

Munro, Argentina

Sanatorio Allende S.A.

Nueva Córdoba, Argentina

Sanatorio Parque S.A.

Rosario, Argentina

Prince of Wales Hospital-Randwick-66496

Randwick, New South Wales, Australia

Cancer Research South Australia

Adelaide, South Australia, Australia

Ballarat Regional Integrated Cancer Centre

Ballarat, Victoria, Australia

Hospital Elisabethinen Linz

Linz, Austria

Johannes Kepler University Linz

Linz, Austria

Standort Penzing der Klinik Ottakring

Vienna, Austria

Centre Hospitalier Interrégional Edith Cavell (CHIREC)

Brussels, Belgium

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Universitair Ziekenhuis Brussel

Jette, Belgium

UZ Leuven

Leuven, Belgium

Hospital de Amor

Barretos, Brazil

Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa Sociedade Simples

Porto Alegre, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre - RS, Brazil

Fundaçao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, Brazil

Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.

Panagyurishte, Bulgaria

MHAT Heart and brain

Pleven, Bulgaria

Verspeeten Family Cancer Centre (LHSC)

London, Ontario, Canada

Sault Area Hospital

Sault Ste. Marie, Ontario, Canada

Icegclinic

La Florida, Chile

Clinica Santa Maria

Providencia, Chile

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 Chest Hospital, Capital Medical University

Beijing, China

The First Affiliated Hospital Of Bengbu Medical College

Bengbu, China

Hunan Province Tumor Hospital

Changsha, China

Sichuan Cancer Hospital

Chengdu, China

West China Hospital, Sichuan University

Chengdu, China

Fujian Cancer Hospital

Fuzhou, China

Sun Yat-Sen University Cancer Center

Guangzhou, China

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, China

The First Affiliated Hospital, Zhejiang University

Hangzhou, China

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

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

Shandong Cancer Hospital

Jinan, China

Linyi Cancer Hospital

Linyi, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

The Second Affiliated Hospital to Nanchang University

Nanchang, China

Nanjing Drum Tower Hospital

Nanjing, China

The Affiliated Cancer Hospital, Guangxi Medical University

Nanning, China

The First Affiliated Hospital of Ningbo University

Ningbo, China

Shanghai Chest Hospital

Shanghai, China

Shanghai Pulmonary Hospital

Shanghai, China

Shanghai Geriatric Medical Center

Shanghai, China

Shanghai General Hospital

Shanghai, China

China Shenyang Chest Hospital

Shenyang, China

Shanxi Cancer hospital

Taiyuan, China

Tianjin Cancer Hospital

Tianjin, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Xiangyang Central Hospital

Xiangyang, China

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, China

Northern Jiangsu People's Hospital

Yangzhou, China

Henan Cancer Hospital

Zhengzhou, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

University Hospital Olomouc

Olomouc, Czechia

University Thomayer´s Hospital

Prague, Czechia

North Estonia Medical Centre Foundation, Tallinn

Tallinn, Estonia

Tartu University Hospital

Tartu, Estonia

KYS Sädesairaala

Kuopio, Finland

Oulun yliopistollinen keskussairaala

Oulu, Finland

Turun Yliopistollinen sairaala

Turku, Finland

INS Cancérologie de l'Ouest

Angers, France

INS Bergonie

Bordeaux, France

CTR François Baclesse

Caen, France

CTR Georges-François Leclerc

Dijon, France

HOP Nord Laennec

Nantes, France

INS Curie

Paris, France

Hôpital Cochin

Paris, France

Hôpital Larrey - CHU de Toulouse

Toulouse, France

HOP Villefranche-sur-Saône

Villefranche-sur-Saône, France

Institut Gustave Roussy

Villejuif, France

ARENSIA Exploratory Medicine LLC

Tbilisi, Georgia

Universitätsklinikum Aachen, AöR

Aachen, Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany

Vivantes Klinikum Spandau

Berlin-Spandau, Germany

Technische Universität Dresden

Dresden, Germany

Universitätsklinikum Essen AöR

Essen, Germany

And 143 more locations on ClinicalTrials.gov

Clinical Research Directory

DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemoimmunotherapy

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (243)