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ACTIVE NOT RECRUITING
NCT05740566
PHASE3

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).

Official title: A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

509

Start Date

2023-05-31

Completion Date

2028-03-26

Last Updated

2026-01-05

Healthy Volunteers

No

Interventions

DRUG

Tarlatamab

Tarlatamab will be administered as an IV infusion.

DRUG

Lurbinectedin

Lurbinectedin will be administered per local SOC.

DRUG

Topotecan

Topotecan will be administered per local SOC.

DRUG

Amrubicin

Amrubicin will be administered per local SOC.

Locations (223)

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Alaska Oncology and Hematology

Anchorage, Alaska, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

University of California Los Angeles

Santa Monica, California, United States

Northwestern University

Chicago, Illinois, United States

University of Illinois Chicago

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Pikeville Medical Center

Pikeville, Kentucky, United States

Our Lady of the Lake Cancer Institute

Baton Rouge, Louisiana, United States

Trinity Health Saint Joseph Mercy Ann Arbor

Ann Arbor, Michigan, United States

University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

University of Missouri Health Care

Columbia, Missouri, United States

Summit Medical Group, Overlook Oncology Center

Summit, New Jersey, United States

New York University Grossman School of Medicine and New York University Langone Hospitals

New York, New York, United States

Perlmutter Cancer Center at New York University Langone Hospital----Long Island

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Northport Veterans Affairs Medical Center

Northport, New York, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Sanford Oncology Clinic and Pharmacy

Sioux Falls, South Dakota, United States

University of Tennessee Medical Center Knoxville

Knoxville, Tennessee, United States

Baptist Cancer Center

Memphis, Tennessee, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Swedish Cancer Institute Medical Oncology

Edmonds, Washington, United States

The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Cemic

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Sociedad de Beneficencia Hospital Italiano

Córdoba, Córdoba Province, Argentina

Clinica Viedma

Viedma, Río Negro Province, Argentina

Sanatorio Parque SA

Rosario, Santa Fe Province, Argentina

Instituto Argentino de Diagnostico y Tratamiento IADT

Buenos Aires, Argentina

Sanatorio Allende

Córdoba, Argentina

Liverpool Hospital

Liverpool, New South Wales, Australia

Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia

Monash Medical Centre

Clayton, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Medizinische Universitaet Graz

Graz, Austria

Universitaetsklinikum Krems

Krems, Austria

Universitair Ziekenhuis Gent

Ghent, Belgium

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, Belgium

AZ Delta Campus Rumbeke

Roeselare, Belgium

Vitaz campus Sint-Niklaas Moerland

Sint-Niklaas, Belgium

Hospital Santa Izabel

Salvador, Estado de Bahia, Brazil

Instituto de Ensino e Pesquisa do Hospital da Bahia

Salvador, Estado de Bahia, Brazil

Liga Norte-Riograndense Contra O Cancer

Natal, Rio Grande do Norte, Brazil

Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Amor da Amazonia

Porto Velho, Rondônia, Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Beneficencia Portuguesa de Sao Paulo - Bp

São Paulo, São Paulo, Brazil

Oncologia Rede D Or

São Paulo, São Paulo, Brazil

Instituto Coi

Rio de Janeiro, Brazil

Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp

São Paulo, Brazil

London Health Sciences Centre

London, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Anhui Chest Hospital

Hefei, Anhui, China

Beijing Tongren Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Army Medical University, PLA

Chongqing, Chongqing Municipality, China

Army Special Medical Center of Peoples Liberation Army

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

The 4th Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Subei Peoples Hospital

Yangzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

Jinan Central Hospital

Jinan, Shandong, China

Shandong Tumor Hospital

Jinan, Shandong, China

Linyi Cancer Hospital

Linyi, Shandong, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanxi Province Cancer Hospital

Taiyuan, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Beijing Chest Hospital, Capital Medical University

Beijing, China

Fujian Cancer Hospital

Fuzhou, China

Tianjin Peoples Hospital

Tianjin, China

Weihai Municipal Hospital

Weihai, China

Fakultni nemocnice Brno

Brno, Czechia

Masarykuv onkologicky ustav

Brno, Czechia

Fakultni nemocnice Olomouc

Olomouc, Czechia

Nemocnice Agel Ostrava-Vitkovice as

Ostrava-Vitkovice, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Rigshospitalet

Copenhagen, Denmark

Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

Grenoble, France

Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon

Lille, France

Centre Hospitalier Regional Universitaire de Limoges - Hopital Dupuytren

Limoges, France

Centre Leon Berard

Lyon, France

Centre Hospitalier Universitaire Nord

Marseille, France

Institut Curie

Paris, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

Rennes, France

Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

Strasbourg, France

Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

Toulouse, France

Gustave Roussy

Villejuif, France

Charite Universitaetsmedizin Berlin, Campus Virchow

Berlin, Germany

Universitaetsklinikum Koeln

Cologne, Germany

Universitaetsklinikum Dresden

Dresden, Germany

Universitaetsklinikum Essen

Essen, Germany

Asklepios Fachkliniken Muenchen Gauting

Gauting, Germany

LungenClinic Grosshansdorf GmbH

Großhansdorf, Germany

Robert-Bosch-Krankenhaus

Stuttgart, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Saint Savas Hospital

Athens, Greece

Henry Dunant Hospital Center

Athens, Greece

Thoracic General Hospital Of Athens Sotiria

Athens, Greece

Alexandra Hospital

Athens, Greece

University Hospital of Heraklion

Heraklion - Crete, Greece

Olympion Therapeftirio General Clinic Of Patras

Pátrai, Greece

Saint Luke Hospital

Thessaloniki, Greece

European Interbalkan Medical Center

Thessaloniki, Greece

Semmelweis Egyetem

Budapest, Hungary

Orszagos Koranyi Pulmonologiai Intezet

Budapest, Hungary

Matrai Gyogyintezet

Gyöngyös, Hungary

Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, Hungary

Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Tatabánya, Hungary

Reformatus Pulmonologiai Centrum

Törökbálint, Hungary

Beaumont Hospital

Dublin, Ireland

Rambam Medical Center

Haifa, Israel

Hadassah Ein-Kerem Medical Center

Jerusalem, Israel

Meir Medical Center

Kfar Saba, Israel

Rabin Medical Center

Petah Tikva, Israel

Humanitas Gavazzeni

Bergamo, Italy

Azienda Ospedaliera Universitaria Renato Dulbecco

Catanzaro, Italy

Ospedale Policlinico San Martino IRCCS

Genova, Italy

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

Meldola (FC), Italy

Azienda Ospedaliera Universitaria San Luigi Gonzaga

Orbassano, Italy

Azienda Ospedaliera San Giovanni Addolorata

Roma, Italy

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

Kurume University Hospital

Kurume-shi, Fukuoka, Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Hyogo Cancer Center

Akashi-shi, Hyōgo, Japan

Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

Kansai Medical University Hospital

Hirakata-shi, Osaka, Japan

Osaka International Cancer Institute

Osaka, Osaka, Japan

Kindai University Hospital

Osakasayama-shi, Osaka, Japan

Saitama Medical University International Medical Center

Hidaka-Shi, Saitama, Japan

Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, Japan

Wakayama Medical University Hospital

Wakayama, Wakayama, Japan

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Hospital Tengku Ampuan Afzan

Kuantan, Pahang, Malaysia

Sarawak General Hospital

Kuching, Sarawak, Malaysia

coi Centro Oncologico Internacional sapi de cv

Tlajomulco de Zúñiga, Jalisco, Mexico

Health Pharma Professional Research SA de CV

Mexico City, Mexico City, Mexico

Oncare

Mexico City, Mexico City, Mexico

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Leids Universitair Medisch Centrum

Leiden, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Centrum Pulmonologii i Torakochirurgii w Bystrej

Bystra, Poland

Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo

Krakow, Poland

Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow

Poznan, Poland

Hospital da Luz, SA

Lisbon, Portugal

Hospital Cuf Descobertas

Lisbon, Portugal

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

Matosinhos Municipality, Portugal

Hospital Cuf porto

Porto, Portugal

Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

Cluj-Napoca, Romania

Centrul de Oncologie Sf Nectarie SRL

Craiova, Romania

Institutul Regional de Oncologie Iasi

Iași, Romania

SC Oncomed SRL

Timișoara, Romania

National Cancer Centre Singapore

Singapore, Singapore

Tan Tock Seng Hospital

Singapore, Singapore

Chungbuk National University Hospital

Cheongju Chungbuk, South Korea

National Cancer Center

Goyang-si Gyeonggi-do, South Korea

Gachon University Gil Hospital

Incheon, South Korea

Gyeongsang National University Hospital

Jinju, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, South Korea

Ulsan University Hospital

Ulsan, South Korea

Hospital Regional Universitario de Malaga

Málaga, Andalusia, Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Aragon, Spain

Hospital del Mar

Barcelona, Catalonia, Spain

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera

A Coruña, Galicia, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Fundacion Jimenez Diaz

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Kantonsspital Graubuenden

Chur, Switzerland

Freiburg Spital

Fribourg, Switzerland

Hopitaux universitaires de Geneve

Geneva, Switzerland

Kantonsspital Sankt Gallen

Sankt Gallen, Switzerland

Kantonsspital Winterthur

Winterthur, Switzerland

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Veterans General Hospital - Taichung

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Memorial Ankara Hastanesi

Ankara, Turkey (Türkiye)

Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

Ankara, Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Ankara, Turkey (Türkiye)

Pamukkale Universitesi Tip Fakultesi Hastanesi

Denizli, Turkey (Türkiye)

Bagcilar Medipol Mega Universite Hastanesi

Istanbul, Turkey (Türkiye)

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

Istanbul, Turkey (Türkiye)

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, Turkey (Türkiye)

Izmir Ekonomi Universitesi Medical Point Hastanesi

Izmir, Turkey (Türkiye)

Inonu Universitesi Turgut Ozal Tip Merkezi

Malatya, Turkey (Türkiye)

University College London Hospital

London, United Kingdom

Guys Hospital

London, United Kingdom

Christie Hospital

Manchester, United Kingdom