A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC
NCT ID: NCT06745323
Last Updated: 2026-01-02
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
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RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2025-02-26
2029-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Arm C: Dose 3 Tarlatamab
Participants will receive dose 3 of Tarlatamab by IV infusion during the treatment period.
Tarlatamab
Tarlatamab will be administered by IV infusion.
Treatment Arm B: Dose 2 Tarlatamab
Participants will receive dose 2 of Tarlatamab by IV infusion during the treatment period.
Tarlatamab
Tarlatamab will be administered by IV infusion.
Treatment Arm A: Dose 1 Tarlatamab
Participants will receive dose 1 of Tarlatamab by intravenous (IV) infusion during the treatment period.
Tarlatamab
Tarlatamab will be administered by IV infusion.
Interventions
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Tarlatamab
Tarlatamab will be administered by IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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 tarlatamab.
* Female participants who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab.
* Female participants planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab.
* Female participants of childbearing potential with a positive pregnancy test assessed at screening and/or day 1 by a highly sensitive urine or 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 tarlatamab.
* 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 tarlatamab.
* Male participants unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab.
* Participant has known sensitivity or is contraindicated 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.
* History or evidence of any other clinically significant disorder, condition or disease determined by the investigator or Amgen physician, if consulted, would pose a risk to the subject safety or interfere with the study evaluation procedure or completion.
18 Years
99 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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University of California Los Angeles
Los Angeles, California, United States
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
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing 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
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Hopital Lyon sud
Pierre-Bénite, , France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, , France
Hopital Foch
Suresnes, , France
Helios Kliniken Emil-von-Behring
Berlin, , Germany
Universitaetsklinikum des Saarlandes
Homburg, , Germany
Universitaetsklinikum Schleswig-Holstein - Kiel
Kiel, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Henry Dunant Hospital Center
Athens, , Greece
Alexandra Hospital
Athens, , Greece
Metropolitan Hospital
Athens, , Greece
University Hospital of Heraklion
Heraklion - Crete, , Greece
University Hospital of Patras
Pátrai, , Greece
European Interbalkan Medical Center
Thessaloniki, , Greece
Azienda Ospedaliera San Giovanni Addolorata
Roma, , Italy
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
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan
Chungbuk National University Hospital
Cheongju Chungbuk, , South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Canary Islands, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera
A Coruña, Galicia, Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Kantonsspital Baden
Baden, , Switzerland
Universitaetsspital Zuerich
Zurich, , Switzerland
Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
Adana, , Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, , Turkey (Türkiye)
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara, , Turkey (Türkiye)
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, , Turkey (Türkiye)
Christie Hospital
Manchester, , United Kingdom
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20240092
Identifier Type: -
Identifier Source: org_study_id
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