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NCT07005128PHASE3Recruiting

A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)

Amgen

Start Date

8/18/2025

Completion Date

7/15/2029

Summary

The main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).

Eligibility Criteria

Age Range: 18 years to 99 years

Inclusion Criteria: * Participant has provided informed consent before initiation of any study-specific activities/procedures. * Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years. * Histologically or cytologically documented ES-SCLC (American Joint Committee on Cancer, 2017, Stage IV SCLC \[T any, N any, M1 a/b/c\]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. * Measurable disease as defined per RECIST 1.1. * Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment. * Minimum life expectancy ≥ 12 weeks. Exclusion Criteria: * Participants can have no history of other malignancy in the last 2 years. * Any symptomatic central nervous system (CNS) metastases, or leptomeningeal disease. * They will have no history of severe or life-threatening events to immune-mediated therapy. * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment. * They will have no active autoimmune or inflammatory disorders. * Presence of active human immunodeficiency virus (HIV) or active Hepatitis (B/C) infection. * Evidence or interstitial lung disease (ILD) or active, non-infectious pneumonitis. * History of solid organ transplant. * They will not have had a myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 6 months prior to first dose of study treatment.

Interventions

DRUG

Tarlatamab

DRUG

Durvalumab

DRUG

Carboplatin

DRUG

Etoposide

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Conditions

Small-cell Lung CancerExtensive Stage Small-cell Lung Cancer

Locations

Cancer and Blood Specialists of Arizona

Casa Grande, Arizona 85222

United States

City of Hope Cancer Center Phoenix

Goodyear, Arizona 85338

United States

Genesis Cancer Center

Hot Springs, Arkansas 71913

United States

Saint Bernards Medical Center

Jonesboro, Arkansas 72401

United States

Providence Saint Jude Medical Center

Fullerton, California 92835

United States

Translational Research in Oncology US Inc, Trio Central Pharmacy

Los Angeles, California 90095

United States

University of California Los Angeles

Santa Monica, California 90404

United States

Presbyterian Intercommunity Hospital Health Whitter Hospital

Whittier, California 90602

United States

Colorado West Healthcare System dba Grand Valley Oncology

Grand Junction, Colorado 81505

United States

Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut

New Britain, Connecticut 06053

United States

Yale New Haven Hospital

New Haven, Connecticut 06510

United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut 06360

United States

Florida Oncology and Hematology

Fort Myers, Florida 33912

United States

Cancer Specialists of North Florida - Southpoint

Jacksonville, Florida 32256

United States

Orlando Health Cancer Institute

Kissimmee, Florida 34744

United States

Central Georgia Cancer Care PC

Macon, Georgia 31210

United States

City of Hope Atlanta

Newnan, Georgia 30265

United States

University of Illinois Chicago

Chicago, Illinois 60612

United States

Cancer Care Specialists of Illinois

Decatur, Illinois 62526

United States

Midwestern Regional Medical Center dba City of Hope Chicago

Rockford, Illinois 61108

United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana 46202

United States

Hematology Oncology of Indiana

Indianapolis, Indiana 46260

United States

Cancer Center of Kansas, Heritage Plaza Medical Building

Wichita, Kansas 67214

United States

New England Cancer Specialists

Westbrook, Maine 04092

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

Minnesota Oncology Hematology PA

Edina, Minnesota 55435

United States

Allina Health System dba Allina Health Cancer Institute

Minneapolis, Minnesota 55407

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi 39401

United States

Cancer Partners of Nebraska

Lincoln, Nebraska 68516

United States

Nebraska Cancer Specialists

Omaha, Nebraska 68130

United States

New York Oncology Hematology PC

Albany, New York 12206

United States

Hematology Oncology Association of Central New York

East Syracuse, New York 13057

United States

New York Cancer and Blood Specialists

Shirley, New York 11967

United States

Oncology Hematology Care, Inc

Cincinnati, Ohio 45242

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Willamette Valley Cancer Institute and Research Center - Eugene

Eugene, Oregon 97401

United States

Kaiser Permanente Medical Center

Portland, Oregon 97227

United States

Baptist Cancer Center

Memphis, Tennessee 38120

United States

United States Oncology Regulatory Affairs Corporate Office

Nashville, Tennessee 37203

United States

Texas Oncology - Dallas Fort Worth

Dallas, Texas 75246

United States

Oncology Consultants

Houston, Texas 77030

United States

US Oncology Research Investigational Products Center

Irving, Texas 75063

United States

University of Texas Health Science Center at Tyler

Tyler, Texas 75701

United States

Texas Oncology Northeast Texas

Tyler, Texas 75702

United States

Virginia Cancer Specialists PC

Fairfax, Virginia 22031

United States

Virginia Oncology Associates

Norfolk, Virginia 23502

United States

Swedish Cancer Institute Medical Oncology

Seattle, Washington 98104

United States

Northwest Medical Specialties, PLLC

Tacoma, Washington 98405

United States

West Virginia University Health Sciences Center

Morgantown, West Virginia 26506

United States

Cemic

Ciudad Autonoma de Buenos Aires, Buenos Aires C1431FWO

Argentina

Hospital Universitario Austral

Pilar, Buenos Aires B1629ODT

Argentina

Sanatorio Parque SA

Rosario, Santa Fe Province 2000

Argentina

Chris OBrien Lifehouse

Camperdown, New South Wales 2050

Australia

Monash Medical Centre

Clayton, Victoria 3168

Australia

Medizinische Universitaet Graz

Graz, 8036

Austria

Universitaetsklinikum Krems

Krems, 3500

Austria

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, 3500

Belgium

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, 3000

Belgium

AZ Delta Campus Rumbeke

Roeselare, 8800

Belgium

Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne

Yvoir, 5530

Belgium

Cenantron Centro Avançado de Tratamento Oncologico Ltda

Belo Horizonte, Minas Gerais 30130-090

Brazil

Liga Norte-Riograndense Contra O Cancer

Natal, Rio Grande do Norte 59062-000

Brazil

Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul 90610-000

Brazil

Fund Faculdade Regional Med Sao Jose Rio Preto

São José do Rio Preto, São Paulo 15090-000

Brazil

Centro de Pesquisa do Hospital Albert Einstein

São Paulo, São Paulo 05652-900

Brazil

Beijing Cancer Hospital

Beijing, Beijing Municipality 100080

China

Beijing Cancer Hospital

Beijing, Beijing Municipality 100142

China

The Second Attached Hospital Of Fujian Medical University

Quanzhou, Fujian 362002

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang 150000

China

Jiamusi Cancer Hospital

Jiamusi, Heilongjiang 154007

China

Henan Cancer Hospital

Zhengzhou, Henan 450003

China

Jiangxi Cancer hospital

Nanchang, Jiangxi 330029

China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi 330209

China

Shandong Cancer Hospital

Jinan, Shandong 250117

China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality 200030

China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality 200433

China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi 030009

China

West China Hospital of Sichuan University

Chengdu, Sichuan 611135

China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality 300060

China

Tianjin Peoples Hospital

Tianjin, Tianjin Municipality 300121

China

The First Affiliated Hospital Of Ningbo University

Ningbo, Zhejiang 315010

China

Fujian Cancer Hospital

Fuzhou, 350011

China

Rigshospitalet

Copenhagen, 2100

Denmark

Regionshospitalet Godstrup

Herning, 7400

Denmark

Centre Hospitalier Intercommunal de Creteil

Créteil, 94010

France

Centre Leon Berard

Lyon, 69008

France

Centre Hospitalier Universitaire Nord

Marseille, 13915

France

Institut Curie

Paris, 75005

France

Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec

Saint-Herblain, 44800

France

Hopital d instruction des armees sainte anne

Toulon, 83800

France

Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

Toulouse, 31059

France

Klinikum Chemnitz GmbH

Chemnitz, 09113

Germany

Krankenhaus Koeln-Merheim - Kliniken der Stadt Koeln gGmbH

Cologne, 51109

Germany

Universitaetsklinikum Dresden

Dresden, 01307

Germany

Universitaetsklinikum Essen

Essen, 45147

Germany

Krankenhaus Nordwest

Frankfurt am Main, 60488

Germany

Asklepios Fachkliniken Muenchen Gauting

Gauting, 82130

Germany

LungenClinic Grosshansdorf GmbH

Großhansdorf, 22927

Germany

Universitaetsklinikum Schleswig-Holstein - Kiel

Kiel, 24105

Germany

Universitaetsklinikum Schleswig-Holstein - Luebeck

Lübeck, 23538

Germany

Universitaetsklinikum Wuerzburg

Würzburg, 97078

Germany

Henry Dunant Hospital Center

Athens, 11526

Greece

Alexandra Hospital

Athens, 11528

Greece

European Interbalkan Medical Center

Thessaloniki, 57001

Greece

Iatriko Diavalkaniko Thessalonikis

Thessaloniki, 57001

Greece

Queen Mary Hospital, The University of Hong Kong

Hong Kong,

Hong Kong

Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories,

Hong Kong

Matrai Gyogyintezet

Gyöngyös, 3200

Hungary

Reformatus Pulmonologiai Centrum

Törökbálint, 2045

Hungary

Meir Medical Center

Kfar Saba, 4428164

Israel

Rabin Medical Center

Petah Tikva, 4941492

Israel

IRCCS Istituto Tumori Giovanni Paolo II

Bari, 70124

Italy

Humanitas Gavazzeni

Bergamo, 24125

Italy

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

Meldola (FC), 47014

Italy

IRCCS Istituto Oncologico Europeo

Milan, 20141

Italy

Azienda Ospedaliera San Giovanni Addolorata

Roma, 00184

Italy

Centro Ricerche Cliniche Di Verona Societa responsabilita limitata

Verona, 37126

Italy

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime 791-0280

Japan

Kyushu University Hospital

Fukuoka, Fukuoka 812-8582

Japan

Kurume University Hospital

Kurume-shi, Fukuoka 830-0011

Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido 003-0804

Japan

Hyogo Cancer Center

Akashi-shi, Hyōgo 673-8558

Japan

Niigata Cancer Center Hospital

Niigata, Niigata 951-8566

Japan

Okayama University Hospital

Okayama, Okayama-ken 700-8558

Japan

Kansai Medical University Hospital

Hirakata-shi, Osaka 573-1191

Japan

Osaka International Cancer Institute

Osaka, Osaka 541-8567

Japan

Kindai University Hospital

Sakai-shi, Osaka 590-0197

Japan

Saitama Medical University International Medical Center

Hidaka-shi, Saitama 350-1298

Japan

Shizuoka Cancer Center

Sunto-gun, Shizuoka 411-8777

Japan

Wakayama Medical University Hospital

Wakayama, Wakayama 641-8510

Japan

Health Pharma Professional Research SA de CV

Mexico City, Mexico City 03100

Mexico

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ

Netherlands

Maastricht Universitair Medisch Centrum

Maastricht, 6229 HX

Netherlands

Erasmus Medisch Centrum

Rotterdam, 3015 GD

Netherlands

Centrum Pulmonologii i Torakochirurgii w Bystrej

Bystra, 43-360

Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214

Poland

Instytut Gruzlicy i Chorob Pluc

Warsaw, 01-138

Poland

Hospital Cuf Tejo

Lisbon, 1350-352

Portugal

Hospital da Luz, SA

Lisbon, 1500-650

Portugal

Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

Matosinhos Municipality, 4464-513

Portugal

Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

Cluj-Napoca, 400015

Romania

Chungbuk National University Hospital

Cheongju Chungbuk, 28644

South Korea

National Cancer Center

Goyang-si Gyeonggi-do, 10408

South Korea

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

Hospital Regional Universitario de Malaga

Málaga, Andalusia 29010

Spain

Hospital Universitari Vall d Hebron

Barcelona, Catalonia 08035

Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia 08036

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia 08041

Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid 28222

Spain

Hospital Universitari i Politecnic La Fe

Valencia, Valencia 46026

Spain

Hospital Universitario Ramon y Cajal

Madrid, 28034

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Universitaetsspital Basel

Basel, 4052

Switzerland

Kantonsspital Graubuenden

Chur, 7000

Switzerland

Hopitaux universitaires de Geneve

Geneva, 1211

Switzerland

National Cheng Kung University Hospital

Tainan, 70403

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Memorial Ankara Hastanesi

Ankara, 06520

Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Ankara, 06800

Turkey (Türkiye)

Bagcilar Medipol Mega Universite Hastanesi

Istanbul, 34214

Turkey (Türkiye)

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

Istanbul, 34722

Turkey (Türkiye)

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, 35100

Turkey (Türkiye)

Sakarya Egitim ve Arastirma Hastanesi

Sakarya, 54290

Turkey (Türkiye)