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Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT06117774•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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

•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.
+21 more criteria

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

Key Dates

Start Date

February 20, 2024

Primary Completion Date

May 29, 2030

Completion Date

May 29, 2030

Last Updated

February 27, 2026

Enrollment

400

ESTIMATED participants

Conditions

Limited Stage Small Cell Lung CancerSmall Cell Lung Cancer

Interventions

Tarlatamab

DRUG

Placebo

DRUG

Contacts

Amgen Call Center

CONTACT

866-572-6436 medinfo@amgen.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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