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Clinical Trials in the UK / NCT06117774
Active, not recruiting Phase 3

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

NCT06117774 · tracked via the Priya Life Science UK tracker
Sponsor
Amgen
Phase
Phase 3
Started
2024-02-20
Last updated
2026-04-29

Condition(s) studied

Limited Stage Small Cell Lung CancerSmall Cell Lung Cancer

Investigational drug(s) / intervention(s)

TarlatamabPlacebo

Tarlatamab: Intravenous (IV) infusion

Placebo: IV infusion

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (204)

FacilityCityRegionStatus
Valkyrie Clinical Trials Los Angeles California
University of California Los Angeles Santa Monica California
Yale New Haven Hospital New Haven Connecticut
Boca Raton Clinical Research Global South Florida Plantation Florida
University of Louisville James Graham Brown Cancer Center Louisville Kentucky
Our Lady of the Lake Cancer Institute Baton Rouge Louisiana
Morristown Medical Center Morristown New Jersey
New York University Grossman School of Medicine and New York University Langone Hospitals New York New York
Perlmutter Cancer Center at New York University Langone Hospital - Long Island New York New York
Montefiore Einstein Center for Cancer Care The Bronx New York
FirstHealth Cancer Center Pinehurst North Carolina
Lehigh Valley Health Network Allentown Pennsylvania
Spokenword Clinical Trials Easton Pennsylvania
Renovatio Clinical The Woodlands Texas
US Oncology Research Investigational Products Center The Woodlands Texas
University of Virginia Health System Charlottesville Virginia
Virginia Cancer Specialists, PC Fairfax Virginia
West Virginia University Health Sciences Center Morgantown West Virginia
Fundacion Respirar Ciudad Autonoma de Buenos Aires Buenos Aires
Hospital Italiano de La Plata La Plata Buenos Aires
Hospital Universitario Austral Pilar Buenos Aires
Instituto Oncologico de Cordoba Ionc Fundacion Richardet Longo Córdoba Córdoba Province
Hospital Aleman Buenos Aires CABA Distrito Federal
Clinica Viedma Viedma Río Negro Province
Sanatorio 9 de Julio Cice 9 de Julio San Miguel de Tucumán Tucumán Province
Instituto Argentino de Diagnóstico y Tratamiento Buenos Aires Argentina
Port Macquarie Base Hospital Port Macquarie New South Wales
Westmead Hospital Westmead New South Wales
Flinders Medical Centre Bedford Park South Australia
Monash Medical Centre Clayton Victoria
Fiona Stanley Hospital Murdoch Western 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
Oncoclinicas Onco Vida Distrito Federal Brasília Federal District
Liga Paranaense do Combate ao Cancer - Hospital Erasto Gaertner Curitba Paraná
Londrina Cancer Hospital Londrina Paraná
Liga Norte-Riograndense Contra O Cancer Natal Rio Grande do Norte

+ 164 more sites — see the full list on the official registry below.

More Amgen trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06117774 on ClinicalTrials.gov ↗ ← All trials in the UK