A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC

Running, not enrolling · Phase 2

Conditions studied: Small Cell Lung Cancer (SCLC)

In brief

The primary objective of this study is to describe the antitumor activity of tarlatamab in participants with small cell lung cancer (SCLC).

Key facts

Study ID

NCT06745323

Run by

Amgen

People needed

252

Starts

2025-02-26

Expected to finish

2029-02-09

Last updated by the study team

2026-03-03

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has provided informed consent prior to initiation of any study specific activities/procedures.
• Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
• Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
• Participants who progressed or recurred following 1 platinum-based regimen.
• Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
• Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
• Minimum life expectancy of 12 weeks.
• Adequate organ function as described per protocol.

You may not qualify if…

• Disease Related
• Previous diagnosis of transformed non-small cell lung cancer (NSCLC) including epidermal growth factor receptor activating mutation positive NSCLC that has transformed to SCLC.
• Symptomatic central nervous system (CNS) metastases with exceptions defined in the protocol.
• Other Medical Conditions
• History of other malignancy within the past 2 years, with exceptions defined in the protocol.
• Evidence of interstitial lung disease or active, non-infectious pneumonitis
• Diagnosis or evidence of leptomeningeal disease.
• Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.
• 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
• Presence or history of viral infection based on criteria per protocol.
• Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
• Known or active infection requiring parenteral antibiotic treatment.
• History of severe or life-threatening events from any immune-mediated therapy.
• Major surgical procedures within 21 days of prior to first dose of study treatment.
• Prior/Concomitant Therapy
• Prior anticancer therapy within 30 days of enrollment (14 days for conventional chemotherapy).
• Prior enrollment on a tarlatamab clinical trial OR prior therapy with any selective inhibitor of the DLL3 pathway.
• Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions.
• Receiving systemic corticosteroid therapy or any other immunosuppressive therapy within 7 days prior to first dose as described per protocol.
• Live and live-attenuated vaccines within 14 days prior to the start of study treatment. Inactive vaccines and live viral non-replicating vaccines within 3 days prior to the first dose of study treatment.
• Prior/Concurrent Clinical Study Experience
• Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
• Other Exclusions

Where it is running

• Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut — Plainville, Connecticut, United States
• AdventHealth Hematology and Oncology — Orlando, Florida, United States
• City of Hope Chicago — Rockford, Illinois, United States
• Health Partners Cancer Center at Regions Hospital — Saint Paul, Minnesota, United States
• New York Oncology Hematology PC — Albany, New York, United States
• Duke University — Durham, North Carolina, United States
• FirstHealth Cancer Center — Pinehurst, North Carolina, United States
• Guthrie Medical Group — Sayre, Pennsylvania, United States
• Tennessee Oncology PLLC - Chattanooga — Chattanooga, Tennessee, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• Virginia Cancer Specialists PC — Fairfax, Virginia, United States
• Fundacion Respirar — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• Instituto de Investigaciones clinicas de Mar del Plata — Mar del Plata, Buenos Aires, Argentina
• Monash Medical Centre — Clayton, Victoria, Australia
• Austin Health, Austin Hospital — Heidelberg, Victoria, Australia
• Grand Hopital de Charleroi - Site des Viviers — Charleroi, Belgium
• Universitair Ziekenhuis Antwerpen — Edegem, Belgium
• Jessa Ziekenhuis - Campus Virga Jesse — Hasselt, Belgium
• 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
• Hospital de Amor — Barretos, São Paulo, Brazil
• Hospital de Base de Sao Jose do Rio Preto — São José do Rio Preto, São Paulo, Brazil
• University of California Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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