Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)
NCT ID: NCT06117774
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2024-02-20
2030-05-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tarlatamab
Participants will receive tarlatamab on Cycle 1 Day 1, 8 and 15, and once every 2 weeks (Q2W) thereafter (cycle is 28 days).
Tarlatamab
Intravenous (IV) infusion
Placebo
Participants will receive placebo on Cycle 1 Day 1, 8 and 15, and Q2W thereafter (cycle is 28 days).
Placebo
IV infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tarlatamab
Intravenous (IV) infusion
Placebo
IV infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
Exclusion Criteria
* Extensive-stage SCLC (ES-SCLC).
* Any previous diagnosis of transformed non-small-cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology.
* Evidence of interstitial lung disease or active, non-infectious pneumonitis. Other Medical Conditions
* History of other malignancy within the past 2 years, with certain exceptions.
* History of solid organ transplantation.
* Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 6 months prior to first dose of study treatment.
* History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
* Exclusion of human immunodeficiency virus (HIV) or active hepatitis infection based on criteria per protocol.
* Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment.
Prior/Concomitant Therapy
* Received sequential chemotherapy and thoracic radiotherapy (no overlap of thoracic radiotherapy with chemotherapy) during chemoradiation.
* Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
* Prior history of severe or life-threatening events from any immune-mediated therapy.
* Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
* Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment.
* Major surgical procedures within 28 days prior to first dose of study treatment.
* Treatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study treatment. Inactive vaccines and live viral non-replicating vaccines within 3 days prior to first dose of study treatment.
Prior/Concurrent Clinical Study Experience
• Treatment in an alternative investigational trial within 28 days prior to enrollment.
Other Exclusions
* Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of study treatment.
* Female participants who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of study treatment.
* Female participants planning to become pregnant or donate eggs while on study through 60 days after the last dose of study treatment.
* Female participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test.
* Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose of study treatment.
* Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of study treatment.
* Male participants unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of study treatment.
* Participant has known sensitivity to any of the products or components to be administered during dosing.
* Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
* History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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 Serdika 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
Attikon University Hospital
Athens, , Greece
Metropolitan Hospital
Athens, , Greece
Saint Lukes Hospital SA
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
Padua, , 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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-506235-15
Identifier Type: OTHER
Identifier Source: secondary_id
20230016
Identifier Type: -
Identifier Source: org_study_id