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Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)
Sponsor: Amgen
Summary
The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS) based on blinded independent central review (BCIR) per response evaluation criteria in solid tumors v1.1 (RECIST 1.1) and on prolonging overall survival (OS).
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tarlatamab Therapy in Subjects With Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Who Have Not Progressed Following Concurrent Chemoradiation Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2024-02-20
Completion Date
2030-05-29
Last Updated
2026-02-27
Healthy Volunteers
No
Interventions
Tarlatamab
Intravenous (IV) infusion
Placebo
IV infusion
Locations (204)
Valkyrie Clinical Trials
Los Angeles, California, United States
University of California Los Angeles
Santa Monica, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Boca Raton Clinical Research Global South Florida
Plantation, Florida, United States
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, United States
Our Lady of the Lake Cancer Institute
Baton Rouge, Louisiana, United States
Morristown Medical Center
Morristown, 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
Montefiore Einstein Center for Cancer Care
The Bronx, New York, United States
FirstHealth Cancer Center
Pinehurst, North Carolina, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Spokenword Clinical Trials
Easton, Pennsylvania, United States
Renovatio Clinical
The Woodlands, Texas, United States
US Oncology Research Investigational Products Center
The Woodlands, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
West Virginia University Health Sciences Center
Morgantown, West Virginia, United States
Fundacion Respirar
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de La Plata
La Plata, Buenos Aires, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina
Instituto Oncologico de Cordoba Ionc Fundacion Richardet Longo
Córdoba, Córdoba Province, Argentina
Hospital Aleman Buenos Aires
CABA, Distrito Federal, Argentina
Clinica Viedma
Viedma, Río Negro Province, Argentina
Sanatorio 9 de Julio Cice 9 de Julio
San Miguel de Tucumán, Tucumán Province, Argentina
Instituto Argentino de Diagnóstico y Tratamiento
Buenos Aires, Argentina
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Medizinische Universitaet Graz
Graz, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, Austria
Institut Jules Bordet
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Hospital Santa Rita
Vitória, Espírito Santo, Brazil
Oncoclinicas Onco Vida Distrito Federal
Brasília, Federal District, Brazil
Liga Paranaense do Combate ao Cancer - Hospital Erasto Gaertner
Curitba, Paraná, Brazil
Londrina Cancer Hospital
Londrina, Paraná, Brazil
Liga Norte-Riograndense Contra O Cancer
Natal, Rio Grande do Norte, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Cipo - Centro Integrado de Pesquisa em Oncologia
Porto Alegre, Rio Grande do Sul, Brazil
Centro de pesquisa em oncologia Hospital Ana Nery
Santa Cruz do Sul, Rio Grande do Sul, Brazil
Centro Catarinense de Pesquisa LTDA
Blumenau, Santa Catarina, Brazil
Fundacao pio xII Barretos
Barretos, São Paulo, Brazil
Fundacao Amaral Carvalho
Jaú, São Paulo, Brazil
Cepho
Santo André, São Paulo, Brazil
Instituto Dor de Pesquisa e Ensino
Rio de Janeiro, Brazil
Instituto Cancer Sao Paulo Icesp
São Paulo, Brazil
Multiprofile Hospital for Active Treatment - Uni Hospital OOD
Panagyurishte, Bulgaria
Complex Oncology Center Plovdiv EOOD
Plovdiv, Bulgaria
Complex Oncology Center Shumen EOOD
Shumen, Bulgaria
University Multiprofile Hospital for Active Treatment Sofiamed OOD
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Sofia, Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, Bulgaria
Multiprofile Hospital for Active Treatment Serdikamed EOOD
Sofia, Bulgaria
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Northern Jiangsu Peoples hospital
Yangzhou, Jiangsu, China
Jiangxi Cancer hospital
Nanchang, Jiangxi, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
Zhejiang Taizhou Hospital
Taizhou, Zhejiang, China
Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic
Bogota, Cundinamarca, Colombia
Instituto Nacional de Cancerologia
Bogota, Cundinamarca, Colombia
Instituto Medico de Alta Tecnologia sas - Imat sas
Montería, Departamento de Córdoba, Colombia
Oncologos del Occidente SAS
Pereira, Risaralda Department, Colombia
Fundacion cardiovascular de Colombia
Bucaramanga, Santander Department, Colombia
Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon
Lille, France
Centre Hospitalier Universitaire Nord
Marseille, France
Centre Hospitalier Universitaire de Nice - Hopital Pasteur
Nice, France
Hopital Bichat Claude Bernard
Paris, France
Hopital Nord Ouest Villefranche sur Saone
Villefranche-sur-Saône, France
Universitaetsklinikum Essen
Essen, Germany
Universitaetsmedizin Goettingen
Göttingen, Germany
Universitaetsklinikum Wuerzburg
Würzburg, Germany
Agios Savvas Anticancer Hospital
Athens, Greece
Henry Dunant Hospital Center
Athens, Greece
Sotiria General Hospital
Athens, Greece
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Athens, Greece
Metropolitan General
Athens, Greece
Metropolitan Hospital
Athens, Greece
Saint Luke Hospital
Thessaloniki, Greece
European Interbalkan Medical Center
Thessaloniki, 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
Centro di Riferimento Oncologico di Aviano
Aviano PN, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
IRCCS Istituto Oncologico Europeo
Milan, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano, Italy
Istituto Oncologico Veneto IRCCS
Padova, Italy
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
Perugia, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Azienda Unita Sanitaria Locale di Reggio Emilia Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
IRCCS Istituto Clinico Humanitas
Rozzano MI, Italy
Ospedale San Giuseppe Moscati
Statte, Italy
National Hospital Organization Nagoya Medical 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
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
Saitama Cancer Center
Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, 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, Japan
Centro Oncologico Personalizado
Cuauhtémoc, Mexico City, Mexico
Oncare
Mexico City, Mexico City, Mexico
Oncocenter Clinica Integral Internacional de Oncologia
Puebla City, Mexico
Phylasis Clinicas Research Toluca
Toluca, Mexico
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Poland
Centrum Pulmonologii i Torakochirurgii w Bystrej
Bystra, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
Lublin, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow
Poznan, Poland
Szpital Specjalistyczny w Prabutach Spolka z Ograniczoną Odpowiedzialnoscia
Prabuty, Poland
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
Przemyśl, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw, Poland
Unidade Local de Saude de Braga, EPE
Braga, Portugal
Hospital da Luz, SA
Lisbon, Portugal
Hospital Cuf porto
Porto, Portugal
Spitalul Clinic de Urgenta Prof Dr Agrippa Ionescu
Balotesti, Ilfov, Romania
Institutul Oncologic, Prof Dr Alexandru Trestioreanu
Bucharest, Romania
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
Spitalul Municipal Ploiesti
Ploieşti, Romania
SC Oncomed SRL
Timișoara, Romania
National Cancer Centre Singapore
Singapore, Singapore
Icon - Mount Alvernia
Singapore, Singapore
Chungbuk National University Hospital
Cheongju Chungbuk, South Korea
National Cancer Center
Goyang-si Gyeonggi-do, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Gyeongsang National University Hospital
Jinju, South Korea
Cha Bundang Medical Center, Cha University
Seongnam-si, Gyeonggi-do, 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
Seoul National University Hospital
Seoul, South Korea
Hospital Regional Universitario de Malaga
Málaga, Andalusia, Spain
Hospital Universitario Virgen del Rocio
Seville, Andalusia, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Aragon, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Canary Islands, Spain
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, Spain
Hospital del Mar
Barcelona, Catalonia, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Galicia, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Instituto Valenciano de Oncologia
Valencia, Valencia, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden
Norrlands Universitetssjukhus
Umeå, Sweden
Kantonsspital Baden
Baden, Switzerland
Universitaetsspital Basel
Basel, Switzerland
Ospedale Regionale di Bellinzona e Vali
Mendrisio, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Ankara Etlik Sehir Hastanesi
Ankara, Turkey (Türkiye)
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)
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, Turkey (Türkiye)
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul, Turkey (Türkiye)
Marmara Universitesi Tip Fakultesi Hastanesi
Istanbul, Turkey (Türkiye)
Dr Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
Izmir, Turkey (Türkiye)
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi Hastanesi
Kocaeli, Turkey (Türkiye)
Medical Park Seyhan Hastanesi
Mersin, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, Turkey (Türkiye)
Guys Hospital
London, United Kingdom
Christie Hospital
Manchester, United Kingdom