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ACTIVE NOT RECRUITING

NCT06117774

PHASE3

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

Sponsor: Amgen

View on ClinicalTrials.gov

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

404

Start Date

2024-02-20

Completion Date

2030-04-20

Last Updated

2026-04-29

Healthy Volunteers

Conditions

Limited Stage Small Cell Lung Cancer Small Cell Lung Cancer

Interventions

DRUG

Tarlatamab

Intravenous (IV) infusion

DRUG

Placebo

IV infusion

Inclusion Criteria: -Participants are eligible to be included in the study only if all of the following criteria apply: * 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 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: -Participants are excluded from the study if any of the following criteria apply: Disease Related * 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.

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

And 104 more locations on ClinicalTrials.gov

Clinical Research Directory

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (204)