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NCT07472517PHASE3Recruiting

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

Boehringer Ingelheim

Start Date

4/13/2026

Completion Date

7/30/2029

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria : 1. Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC) 2. Patients without any previous systematic anti-cancer treatment for ES-SCLC. Patients who received previous systematic 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 14 days prior to randomisation and 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 are 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 sites within 14 days prior to randomisation 4. Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia/fatigue, amenorrhea/menstrual disorders, CTCAE Grade 2 peripheral neuropathy, and 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) 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.

Interventions

DRUG

obrixtamig

DRUG

atezolizumab

DRUG

carboplatin

DRUG

etoposide

Interested in This Trial?

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Conditions

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

Locations

Infirmary Cancer Care

Mobile, Alabama 36607

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas 72205

United States

Bioresearch Partner - Hialeah Hospital

Hialeah, Florida 33013

United States

Emory University

Atlanta, Georgia 30322

United States

Norton Cancer Institute, Downtown

Louisville, Kentucky 40202

United States

Pikeville Medical Center

Pikeville, Kentucky 41501

United States

Epic Medical Research - Monroe

Monroe, Louisiana 71201

United States

Ochsner Medical Center

New Orleans, Louisiana 70121

United States

Epic Medical Research - Shreveport

Shreveport, Louisiana 71105

United States

University of Maryland School of Medicine

Baltimore, Maryland 21201

United States

Veterans Affairs Ann Arbor Healthcare System

Ann Arbor, Michigan 48105

United States

HCA MidAmerica Division, Inc.

Kansas City, Missouri 64132

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

Cape Fear Valley Cancer Center

Fayetteville, North Carolina 28303

United States

AHN Cancer Institute - Allegheny General

Pittsburgh, Pennsylvania 15212

United States

Baptist Cancer Center - Memphis

Memphis, Tennessee 38120

United States

University of Wisconsin

Madison, Wisconsin 53792

United States

Hospital Britanico de Buenos Aires

CABA, 1280AEB

Argentina

Clinica Adventista Belgrano

CABA, 1430

Argentina

Clinica Privada Independencia

Munro, B1605

Argentina

Sanatorio Allende S.A.

Nueva Córdoba, X5000JHQ

Argentina

Sanatorio Parque S.A.

Rosario, S2000DSV

Argentina

Prince of Wales Hospital-Randwick-66496

Randwick, New South Wales 2031

Australia

Cancer Research South Australia

Adelaide, South Australia 5000

Australia

Ballarat Regional Integrated Cancer Centre

Ballarat, Victoria 3350

Australia

Hospital Elisabethinen Linz

Linz, 4020

Austria

Johannes Kepler University Linz

Linz, 4020

Austria

Standort Penzing der Klinik Ottakring

Vienna, 1160

Austria

Universitair Ziekenhuis Antwerpen

Edegem, 2650

Belgium

Universitair Ziekenhuis Brussel

Jette, 1090

Belgium

UZ Leuven

Leuven, 3000

Belgium

Hospital de Amor

Barretos, 14784-400

Brazil

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

Porto Alegre, 90110-270

Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre - RS, CEP 90020-090

Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, 15090-000

Brazil

Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.

Panagyurishte, 4500

Bulgaria

MHAT Heart and brain

Pleven, 5800

Bulgaria

Acibadem City Clinic Tokuda University Hospital EAD

Sofia, 1407

Bulgaria

Verspeeten Family Cancer Centre (LHSC)

London, Ontario N6A 5W9

Canada

Sault Area Hospital

Sault Ste. Marie, Ontario P6B 0A8

Canada

Icegclinic

La Florida, 8240000

Chile

Clinica Santa Maria

Providencia,

Chile

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, 100036

China

Beijing Chest Hospital, Capital Medical University

Beijing, 101149

China

The First Affiliated Hospital Of Bengbu Medical College

Bengbu, 233004

China

Hunan Province Tumor Hospital

Changsha, 410013

China

Sichuan Cancer Hospital

Chengdu, 610041

China

West China Hospital, Sichuan University

Chengdu, 610041

China

Fujian Cancer Hospital

Fuzhou, 350014

China

Sun Yat-Sen University Cancer Center

Guangzhou, 510060

China

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, 510080

China

The First Affiliated Hospital, Zhejiang University

Hangzhou, 310003

China

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

Hangzhou, 310016

China

Harbin Medical University Cancer Hospital

Harbin, 150081

China

Shandong Cancer Hospital

Jinan, 250117

China

Linyi Cancer Hospital

Linyi, 276034

China

The First Affiliated Hospital of Nanchang University

Nanchang, 330000

China

The Second Affiliated Hospital to Nanchang University

Nanchang, 330006

China

Nanjing Drum Tower Hospital

Nanjing, 210008

China

The Affiliated Cancer Hospital, Guangxi Medical University

Nanning, 530021

China

The First Affiliated Hospital of Ningbo University

Ningbo, 315010

China

Shanghai Chest Hospital

Shanghai, 200030

China

Shanghai Pulmonary Hospital

Shanghai, 200433

China

Shanghai Geriatric Medical Center

Shanghai, 201104

China

Shanghai General Hospital

Shanghai, 210000

China

China Shenyang Chest Hospital

Shenyang, 110000

China

Shanxi Cancer hospital

Taiyuan, 030000

China

Tianjin Cancer Hospital

Tianjin, 300060

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000

China

Wuhan Union Hospital

Wuhan, 430048

China

Xiangyang Central Hospital

Xiangyang, 441138

China

Affiliated Hospital, Xuzhou Medical college

Xuzhou, 221006

China

Northern Jiangsu People's Hospital

Yangzhou, 225001

China

Henan Cancer Hospital

Zhengzhou, 450003

China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, 450015

China

University Hospital Olomouc

Olomouc, 77900

Czechia

University Thomayer´s Hospital

Prague, 140 59

Czechia

North Estonia Medical Centre Foundation, Tallinn

Tallinn, 13419

Estonia

Tartu University Hospital

Tartu, 50406

Estonia

KYS Sädesairaala

Kuopio, 70029

Finland

Oulun yliopistollinen keskussairaala

Oulu, 90220

Finland

Turun Yliopistollinen sairaala

Turku, 20521

Finland

INS Cancérologie de l'Ouest

Angers, 49055

France

INS Bergonie

Bordeaux, 33000

France

CTR François Baclesse

Caen, 14076

France

CTR Georges-François Leclerc

Dijon, 21079

France

HOP Nord Laennec

Nantes, 44093

France

INS Curie

Paris, 75005

France

Hôpital Cochin

Paris, 75014

France

Hôpital Larrey - CHU de Toulouse

Toulouse, 31059

France

HOP Villefranche-sur-Saône

Villefranche-sur-Saône, 69400

France

Institut Gustave Roussy

Villejuif, 94800

France

ARENSIA Exploratory Medicine LLC

Tbilisi, 0112

Georgia

Universitätsklinikum Aachen, AöR

Aachen, 52074

Germany

Charité - Universitätsmedizin Berlin

Berlin, 13353

Germany

Vivantes Klinikum Spandau

Berlin-Spandau, 13585

Germany

Technische Universität Dresden

Dresden, 01307

Germany

Universitätsklinikum Frankfurt

Frankfurt, 60590

Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106

Germany

Asklepios Fachkliniken München-Gauting

Gauting, 82131

Germany

Universitätsmedizin Göttingen, Georg-August-Universität

Göttingen, 37075

Germany

LungenClinic Grosshansdorf GmbH

Großhansdorf, 22927

Germany

Asklepios Kliniken GmbH & Co. KGaA

Hamburg, 21075

Germany

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

Heidelberg, 69126

Germany

Westfälische Wilhelms-Universität Münster

Münster, 48149

Germany

Pius-Hospital, Oldenburg

Oldenburg, 26121

Germany

Universitätsklinikum Würzburg AÖR

Würzburg, 97078

Germany

Chest Hospital of Athens "Sotiria"

Athens, 115 27

Greece

Henry Dunant Hospital, Athens

Athens, 11526

Greece

General Hospital of Thessaloniki "G. Papanikolaou"

Thessaloniki, 57010

Greece

Queen Mary Hospital

Hong Kong,

Hong Kong

Prince of Wales Hospital-Hong Kong-20715

Shatin, 999077

Hong Kong

Koranyi National Institute For Pulmonolgy

Budapest, 1121

Hungary

University of Debrecen Clinical Centre

Debrecen, 4032

Hungary

Bekes County Central Hospital

Gyula, 5700

Hungary

Bacs-Kiskun Megyei Onkormanyzat Hospital

Kecskemét, 6000

Hungary

Tolna County Balassa Janos Hospital

Szekszárd, 7100

Hungary

Reformed Pulmonology Center

Törökbálint, 2045

Hungary

Cork University Hospital

Cork, T12 DFK4

Ireland

Centro di riferimento Oncologico

Aviano (PN), 33081

Italy

Istituto Tumori Giovanni Paolo II

Bari, 70124

Italy

ASST degli Spedali Civili di Brescia

Brescia, 25123

Italy

A. O. Universitaria Careggi

Florence, 50134

Italy

Istituto Scientifico Romagnolo

Meldola (FC), 47014

Italy

AOU San Luigi Gonzaga

Orbassano (TO), 10043

Italy

Istituto Oncologico Veneto IRCCS

Padova, 35128

Italy

Azienda Ospedaliera Unversitaria di Parma

Parma, 43100

Italy

Fondazione Policlinico Universitario Campus Bio-medico

Roma, 00128

Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37126

Italy

Fujita Health University Hospital

Aichi, Toyoake, 470-1192

Japan

Hirosaki University Hospital

Aomori, Hirosaki, 036-8563

Japan

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582

Japan

Hokkaido University Hospital

Hokkaido, Sapporo, 060-8648

Japan

Kagoshima University Hospital

Kagoshima, Kagoshima, 890-8520

Japan

Sendai Kousei Hospital

Miyagi, Sendai, 981-0914

Japan

Kindai University Hospital

Osaka, Sakai, 590-0197

Japan

Saitama Medical University International Medical Center

Saitama, Hidaka, 350-1298

Japan

Hamamatsu University Hospital

Shizuoka, Hamamatsu, 431-3192

Japan

National Cancer Center Hospital

Tokyo, Chuo-ku, 104-0045

Japan

Japanese Foundation for Cancer Research

Tokyo, Koto-ku, 135-8550

Japan

Wakayama Medical University Hospital

Wakayama, Wakayama, 641-8510

Japan

Pauls Stradins Clinical University Hospital

Riga, 1002

Latvia

Rigas Austrumu kliniska universitates slimnica SIA

Riga, 1079

Latvia

Hospital Pulau Pinang-Georgetown, Pulau Pinang-40766

George Town, 10450

Malaysia

Hospital Wanita Dan Kanak-Kanak Sabah

Kota Kinabalu, 88996

Malaysia

Sarawak General Hospital

Kuching, 93586

Malaysia

National Cancer Institute (IKN)

Putrajaya, 62250

Malaysia

Sunway Medical Centre

Selangor Darul Ehsan, 47500

Malaysia

Health Pharma Professional Research S.A. de C.V.

Mexico City, 03100

Mexico

Centro Oncologico Personalizado

México, 06760

Mexico

Instituto Nacional de Cancerologia

México, 14080

Mexico

Centro Medico Zambrano Hellion

Monterrey, 66278

Mexico

Hospital Universitario Dr Jose Eleuterio Gonzalez

Nuevo León, 64460

Mexico

Centro Oncologico Estatal ISSEMyM "Dr. Jose Luis Barrera Franco"

Toluca, 50180

Mexico

ARENSIA Exploratory Medicine

Chisinau, MD-2025

Moldova

Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)

Amsterdam, 1066CX

Netherlands

Maastricht University Medisch Centrum

Maastricht, 6229 HX

Netherlands

Erasmus Medisch Centrum

Rotterdam, 3015 GD

Netherlands

Auckland City Hospital

Auckland, 1023

New Zealand

Waikato Hospital

Hamilton, 3204

New Zealand

Haukeland Universitetssykehus

Bergen, 5021

Norway

Oslo Universitetssykehus HF, Radiumhospitalet

Oslo, N-0379

Norway

St. Olavs Hospital, Universitetssykehuset i Trondheim

Trondheim, 7030

Norway

UCK Clinical Research Support Center

Gdansk, 80-214

Poland

Polish Mother's Memorial Hospital - Research Institute

Lodz, 93338

Poland

University Clinical Hospital No. 4 in Lublin

Lublin, 20090

Poland

Warmia and Mazury Center for Lung Diseases in Olsztyn

Olsztyn, 10-357

Poland

ULS Braga

Braga, 4710-243

Portugal

CHUC - Centro Hospitalar e Universitario de Coimbra, EPE

Coimbra, 3004-561

Portugal

Hospital da Luz

Lisbon, 1500-650

Portugal

Hospital CUF Porto

Porto, 4100-180

Portugal

IPO Porto Francisco Gentil, EPE

Porto, 4200-072

Portugal

Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti

Bucharest, 022328

Romania

Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca

Cluj-Napoca, 400015

Romania

Centrul De Oncologie SF Nectarie S.R.L.

Craiova, 200542

Romania

National Cancer Centre Singapore

Singapore, 168583

Singapore

Tan Tock Seng Hospital

Singapore, 308433

Singapore

Pusan National University Hospital

Busan, 49241

South Korea

Chungnam National University Hospital

Daejoen, 35015

South Korea

National Cancer Center

Goyang, 10408

South Korea

Chonnam National University Hwasun Hospital

Hwasun, 58128

South Korea

Seoul National University Bundang Hospital

Seongnam, 13620

South Korea

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

Korea University Guro Hospital

Seoul, 08308

South Korea

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006

Spain

Hospital del Mar

Barcelona, 08003

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Institut Català d'Oncologia de Girona.

Girona, 17007

Spain

Hospital Duran i Reynals

L'Hospitalet de Llobregat, 08908

Spain

H. Universitario Insular de Canarias

Las Palmas de Gran Canaria, 35016

Spain

Hospital Universitario Ramon Y Cajal

Madrid, 28034

Spain

Fundación Jiménez Díaz

Madrid, 28040

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Puerta de Hierro

Madrid, 28222

Spain

Hospital Regional Universitario de Málaga

Málaga, 29010

Spain

Hospital Son Espases

Palma de Mallorca, 07120

Spain

Clínica Universidad de Navarra

Pamplona, 31008

Spain

Hospital Universitario Virgen De La Macarena

Seville, 41009

Spain

Hospital Clinico Universitario de Valencia

Valencia, 46010

Spain

Hospital Universitari i Politècnic La Fe

Valencia, 46016

Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009

Spain

Gävle sjukhus

Gävle, 801 87

Sweden

Sahlgrenska Universitetssjukhuset, Östra

Gothenburg, 413 46

Sweden

Karolinska Universitetssjukhuset Solna

Stockholm, 171 76

Sweden

Kantonsspital Baden AG

Baden, 5404

Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011

Switzerland

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807

Taiwan

Taichung Veterans General Hospital

Taichung, 40705

Taiwan

National Cheng Kung University Hospital

Tainan, 70403

Taiwan

National Taiwan University Hospital

Taipei, 10048

Taiwan

National Taiwan University Cancer Center

Taipei, 106

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan City, 333

Taiwan

Vajira Hospital

Bangkok, 10300

Thailand

Siriraj Hospital

Bangkok, 10700

Thailand

Maharaj Nakom Chiangmai Hospital

Chiang Mai, 50200

Thailand

Songklanagarind Hospital

Hat Yai, 90110

Thailand

Adana Şehir Hastanesi

Adana,

Turkey (Türkiye)

Medical Park Adana Hastanesi

Adana,

Turkey (Türkiye)

Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi

Ankara, 06018

Turkey (Türkiye)

Ankara Liv Hastanesi

Ankara,

Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi

Ankara,

Turkey (Türkiye)

Samsun Medical Park Hastanesi

Atakum,

Turkey (Türkiye)

Medeniyet University

Istanbul, 34862

Turkey (Türkiye)

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

Istanbul, 34890

Turkey (Türkiye)

Ege Üniversitesi Tıp Fakültesi

Izmir,

Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Türkiye,

Turkey (Türkiye)

Velindre Cancer Centre

Cardiff, CF14 2TL

United Kingdom

Leicester Royal Infirmary

Leicester, LE1 5WW

United Kingdom

The Christie Hospital

Manchester, M20 4BX

United Kingdom

The Royal Marsden Hospital, Sutton

Sutton, SM2 5PT

United Kingdom

Torbay Hospital

Torquay, TQ2 7AA

United Kingdom

Hanoi Oncology Hospital

Hanoi, 100000

Vietnam

Vietnam National Cancer Hospital

Hanoi, 100000

Vietnam

Ho Chi Minh Oncology Hospital

Ho Chi Minh City, 70000

Vietnam

University Medical Center HCMC

Ho Chi Minh City, 70000

Vietnam