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
Status: Recruiting
Location: See all (203) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participant has provided informed consent prior to 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 confirmed small-cell lung cancer (SCLC).
• Diagnosed and treated for LS-SCLC with concurrent chemotherapy and radiotherapy.
• Has completed chemoradiotherapy without progression per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1.) (ie, achieved complete response \[CR\], partial response \[PR\], or stable disease \[SD\]).
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
• Minimum life expectancy of 12 weeks.
• Adequate organ function.
• Toxicities attributed to concurrent chemoradiotherapy resolved to grade ≤ 1, unless otherwise specified. Excluding alopecia or fatigue.
Locations
United States
California
Valkyrie Clinical Trials
RECRUITING
Los Angeles
University of California Los Angeles
RECRUITING
Santa Monica
Connecticut
Yale New Haven Hospital
RECRUITING
New Haven
Florida
Boca Raton Clinical Research Global South Florida
RECRUITING
Plantation
Kentucky
University of Louisville James Graham Brown Cancer Center
RECRUITING
Louisville
Louisiana
Our Lady of the Lake Cancer Institute
RECRUITING
Baton Rouge
North Carolina
FirstHealth Cancer Center
RECRUITING
Pinehurst
New Jersey
Morristown Medical Center
RECRUITING
Morristown
New York
New York University Grossman School of Medicine and New York University Langone Hospitals
COMPLETED
New York
Perlmutter Cancer Center at New York University Langone Hospital - Long Island
COMPLETED
New York
Montefiore Einstein Center for Cancer Care
TERMINATED
The Bronx
Pennsylvania
Lehigh Valley Health Network
RECRUITING
Allentown
Spokenword Clinical Trials
RECRUITING
Easton
Texas
Renovatio Clinical
RECRUITING
The Woodlands
US Oncology Research Investigational Products Center
RECRUITING
The Woodlands
Virginia
University of Virginia Health System
TERMINATED
Charlottesville
Virginia Cancer Specialists, PC
RECRUITING
Fairfax
West Virginia
West Virginia University Health Sciences Center
TERMINATED
Morgantown
Other Locations
Argentina
Instituto Argentino de Diagnóstico y Tratamiento
RECRUITING
Buenos Aires
Hospital Aleman Buenos Aires
RECRUITING
Caba
Fundacion Respirar
RECRUITING
Ciudad Autonoma De Buenos Aires
Instituto Oncologico de Cordoba Ionc Fundacion Richardet Longo
RECRUITING
Córdoba
Hospital Italiano de La Plata
RECRUITING
La Plata
Hospital Universitario Austral
RECRUITING
Pilar
Sanatorio 9 de Julio Cice 9 de Julio
RECRUITING
San Miguel De Tucumán
Clinica Viedma
RECRUITING
Viedma
Australia
Flinders Medical Centre
RECRUITING
Bedford Park
Monash Medical Centre
RECRUITING
Clayton
Fiona Stanley Hospital
RECRUITING
Murdoch
Port Macquarie Base Hospital
RECRUITING
Port Macquarie
Westmead Hospital
RECRUITING
Westmead
Austria
Medizinische Universitaet Graz
RECRUITING
Graz
Universitaetsklinikum Allgemeines Krankenhaus Wien
RECRUITING
Vienna
Belgium
Institut Jules Bordet
TERMINATED
Brussels
Universitair Ziekenhuis Gent
TERMINATED
Ghent
Brazil
Fundação Pio XII Barretos
RECRUITING
Barretos
Centro Catarinense de Pesquisa LTDA
RECRUITING
Blumenau
Oncoclinicas Onco Vida Distrito Federal
RECRUITING
Brasília
Liga Paranaense do Combate ao Cancer - Hospital Erasto Gaertner
RECRUITING
Curitba
Fundacao Amaral Carvalho
RECRUITING
Jaú
Londrina Cancer Hospital
RECRUITING
Londrina
Liga Norte-Riograndense Contra O Cancer
RECRUITING
Natal
Cipo - Centro Integrado de Pesquisa em Oncologia
RECRUITING
Porto Alegre
Hospital das Clinicas de Porto Alegre
RECRUITING
Porto Alegre
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
RECRUITING
Porto Alegre
Instituto Dor de Pesquisa e Ensino
RECRUITING
Rio De Janeiro
Centro de pesquisa em oncologia Hospital Ana Nery
RECRUITING
Santa Cruz Do Sul
Cepho
RECRUITING
Santo André
Instituto Cancer Sao Paulo Icesp
RECRUITING
São Paulo
Hospital Santa Rita
RECRUITING
Vitória
Bulgaria
Multiprofile Hospital for Active Treatment - Uni Hospital OOD
RECRUITING
Panagyurishte
Complex Oncology Center Plovdiv EOOD
RECRUITING
Plovdiv
Complex Oncology Center Shumen EOOD
RECRUITING
Shumen
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
RECRUITING
Sofia
Multiprofile Hospital for Active Treatment Serdika EOOD
RECRUITING
Sofia
University Multiprofile Hospital for Active Treatment Sofiamed OOD
RECRUITING
Sofia
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
RECRUITING
Sofia
China
Beijing Cancer Hospital
RECRUITING
Beijing
The First Bethune Hospital of Jilin University
RECRUITING
Changchun
Hunan Cancer Hospital
RECRUITING
Changsha
Chongqing University Cancer Hospital
RECRUITING
Chongqing
Fujian Cancer Hospital
RECRUITING
Fuzhou
Mengchao Hepatobiliary Hospital of Fujian Medical University
RECRUITING
Fuzhou
Sun Yat-Sen University Cancer Center
RECRUITING
Guangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Cancer Hospital of Shandong First Medical University
RECRUITING
Jinan
Jiangxi Cancer hospital
RECRUITING
Nanchang
Ningbo Medical Center Lihuili Hospital
RECRUITING
Ningbo
Qingdao Municipal Hospital
RECRUITING
Qingdao
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Shanxi Provincial Cancer Hospital
RECRUITING
Taiyuan
Zhejiang Taizhou Hospital
RECRUITING
Taizhou
Tianjin Cancer Hospital
RECRUITING
Tianjin
The First Affiliated Hospital of Xinjiang Medical University
RECRUITING
Ürümqi
Hubei Cancer Hospital
RECRUITING
Wuhan
Renmin Hospital of Wuhan University
RECRUITING
Wuhan
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Northern Jiangsu Peoples hospital
RECRUITING
Yangzhou
Henan Cancer Hospital
RECRUITING
Zhengzhou
Colombia
Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic
RECRUITING
Bogota
Instituto Nacional de Cancerologia
RECRUITING
Bogota
Fundacion cardiovascular de Colombia
RECRUITING
Bucaramanga
Instituto Medico de Alta Tecnologia sas - Imat sas
RECRUITING
Montería
Oncologos del Occidente SAS
RECRUITING
Pereira
France
Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon
COMPLETED
Lille
Centre Hospitalier Universitaire Nord
RECRUITING
Marseille
Centre Hospitalier Universitaire de Nice - Hopital Pasteur
RECRUITING
Nice
Hopital Bichat Claude Bernard
RECRUITING
Paris
Hopital Nord Ouest Villefranche sur Saone
RECRUITING
Villefranche-sur-saône
Germany
Universitaetsklinikum Essen
RECRUITING
Essen
Universitaetsmedizin Goettingen
RECRUITING
Göttingen
Universitaetsklinikum Wuerzburg
RECRUITING
Würzburg
Greece
Agios Savvas Anticancer Hospital
RECRUITING
Athens
Attikon University Hospital
RECRUITING
Athens
Henry Dunant Hospital Center
RECRUITING
Athens
Metropolitan Hospital
RECRUITING
Athens
Sotiria General Hospital
RECRUITING
Athens
European Interbalkan Medical Center
RECRUITING
Thessaloniki
Saint Lukes Hospital SA
RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Queen Mary Hospital, The University of Hong Kong
RECRUITING
Hong Kong
Prince of Wales Hospital, Chinese University of Hong Kong
RECRUITING
Shatin, New Territories
Italy
Centro di Riferimento Oncologico di Aviano
RECRUITING
Aviano Pn
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
IRCCS Istituto Oncologico Europeo
RECRUITING
Milan
Azienda Ospedaliera Universitaria San Luigi Gonzaga
RECRUITING
Orbassano
Istituto Oncologico Veneto IRCCS
RECRUITING
Padua
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
RECRUITING
Perugia
Azienda Ospedaliero Universitaria Pisana
RECRUITING
Pisa
Azienda Unita Sanitaria Locale di Reggio Emilia Arcispedale Santa Maria Nuova
RECRUITING
Reggio Emilia
IRCCS Istituto Clinico Humanitas
RECRUITING
Rozzano Mi
Ospedale San Giuseppe Moscati
RECRUITING
Statte
Japan
Juntendo University Hospital
RECRUITING
Bunkyo-ku
National Cancer Center Hospital
RECRUITING
Chuo-ku
Saitama Medical University International Medical Center
RECRUITING
Hidaka-shi
Kansai Medical University Hospital
RECRUITING
Hirakata-shi
National Cancer Center Hospital East
RECRUITING
Kashiwa-shi
Saitama Cancer Center
RECRUITING
Kitaadachi-gun
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
RECRUITING
Koto-ku
Kurume University Hospital
RECRUITING
Kurume-shi
National Hospital Organization Shikoku Cancer Center
RECRUITING
Matsuyama
National Hospital Organization Nagoya Medical Center
RECRUITING
Nagoya
Niigata Cancer Center Hospital
RECRUITING
Niigata
Okayama University Hospital
RECRUITING
Okayama
Osaka International Cancer Institute
RECRUITING
Osaka
Kindai University Hospital
RECRUITING
Osakasayama-shi
National Hospital Organization Hokkaido Cancer Center
RECRUITING
Sapporo
Sendai Kousei Hospital
RECRUITING
Sendai
Dokkyo Medical University Hospital
RECRUITING
Shimotsuga-gun
Shizuoka Cancer Center
RECRUITING
Sunto-gun
Wakayama Medical University Hospital
RECRUITING
Wakayama
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
RECRUITING
Yokohama
Mexico
Centro Oncologico Personalizado
RECRUITING
Cuauhtémoc
Oncare
RECRUITING
Mexico City
Oncocenter Clinica Integral Internacional de Oncologia
RECRUITING
Puebla City
Phylasis Clinicas Research Toluca
RECRUITING
Toluca
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
RECRUITING
Bialystok
Centrum Pulmonologii i Torakochirurgii w Bystrej
RECRUITING
Bystra
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Uniwerystecki Szpital Kliniczny Nr 4 w Lublinie
RECRUITING
Lublin
Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow
RECRUITING
Poznan
Szpital Specjalistyczny w Prabutach Spolka z Ograniczoną Odpowiedzialnoscia
RECRUITING
Prabuty
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
RECRUITING
Przemyśl
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
RECRUITING
Warsaw
Portugal
Unidade Local de Saude de Braga, EPE
RECRUITING
Braga
Hospital da Luz, SA
RECRUITING
Lisbon
Hospital Cuf porto
RECRUITING
Porto
Republic of Korea
Chungbuk National University Hospital
RECRUITING
Cheongju Chungbuk
National Cancer Center
RECRUITING
Goyang-si Gyeonggi-do
Gachon University Gil Hospital
RECRUITING
Incheon
Gyeongsang National University Hospital
RECRUITING
Jinju
Cha Bundang Medical Center, Cha University
RECRUITING
Seongnam-si, Gyeonggi-do
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si, Gyeonggi-do
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
Romania
Spitalul Clinic de Urgenta Prof Dr Agrippa Ionescu
RECRUITING
Balotesti, Ilfov
Institutul Oncologic, Prof Dr Alexandru Trestioreanu
RECRUITING
Bucharest
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
RECRUITING
Cluj-napoca
Centrul de Oncologie Sf Nectarie SRL
RECRUITING
Craiova
Institutul Regional de Oncologie Iasi
RECRUITING
Iași
Spitalul Municipal Ploiesti
RECRUITING
Ploieşti
SC Oncomed SRL
RECRUITING
Timișoara
Singapore
Icon - Mount Alvernia
RECRUITING
Singapore
National Cancer Centre Singapore
RECRUITING
Singapore
Spain
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
RECRUITING
Badalona
Hospital Clinic i Provincial de Barcelona
RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital del Mar
RECRUITING
Barcelona
Hospital Universitari Vall d Hebron
RECRUITING
Barcelona
Hospital Universitario Insular de Gran Canaria
RECRUITING
Las Palmas De Gran Canaria
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITING
Majadahonda
Hospital Regional Universitario de Malaga
RECRUITING
Málaga
Clinica Universidad de Navarra
RECRUITING
Pamplona
Hospital Clinico Universitario de Santiago
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Instituto Valenciano de Oncologia
RECRUITING
Valencia
Hospital Clinico Universitario Lozano Blesa
RECRUITING
Zaragoza
Sweden
Sahlgrenska Universitetssjukhuset
TERMINATED
Gothenburg
Norrlands Universitetssjukhus
TERMINATED
Umeå
Switzerland
Kantonsspital Baden
TERMINATED
Baden
Universitaetsspital Basel
TERMINATED
Basel
Ospedale Regionale di Bellinzona e Vali
TERMINATED
Mendrisio
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Turkey
Ankara Bilkent Sehir Hastanesi
RECRUITING
Ankara
Ankara Etlik Sehir Hastanesi
RECRUITING
Ankara
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
RECRUITING
Ankara
Memorial Ankara Hastanesi
RECRUITING
Ankara
Bagcilar Medipol Mega Universite Hastanesi
RECRUITING
Istanbul
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
RECRUITING
Istanbul
Marmara Universitesi Tip Fakultesi Hastanesi
RECRUITING
Istanbul
Dr Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
RECRUITING
Izmir
Izmir Ekonomi Universitesi Medical Point Hastanesi
RECRUITING
Izmir
Kocaeli Universitesi Tip Fakultesi Hastanesi
RECRUITING
Kocaeli
Medical Park Seyhan Hastanesi
RECRUITING
Mersin
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
RECRUITING
Samsun
United Kingdom
Guys Hospital
RECRUITING
London
Christie Hospital
RECRUITING
Manchester
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2024-02-20
Estimated Completion Date: 2030-03-31
Participants
Target number of participants: 400
Treatments
Experimental: Tarlatamab
Participants will receive tarlatamab on Cycle 1 Day 1, 8 and 15, and once every 2 weeks (Q2W) thereafter (cycle is 28 days).
Placebo_comparator: Placebo
Participants will receive placebo on Cycle 1 Day 1, 8 and 15, and Q2W thereafter (cycle is 28 days).
Related Therapeutic Areas
Sponsors
Leads: Amgen