Tarlatamab: Tarlatamab will be administered by IV infusion.
Study summary
The primary objective of this study is to describe the antitumor activity of tarlatamab in participants with small cell lung cancer (SCLC).
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* 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.
Primary outcome measure(s)
Proportion of participants with confirmed objective response to Tarlatamab — Approximately 52 Months
Proportion of participants with complete response to Tarlatamab — Approximately 52 Months
Proportion of participants with partial response to Tarlatamab — Approximately 52 Months
Trial sites (78)
Facility
City
Region
Status
University of California Los Angeles
Los Angeles
California
Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut
Plainville
Connecticut
AdventHealth Hematology and Oncology
Orlando
Florida
City of Hope Chicago
Rockford
Illinois
Health Partners Cancer Center at Regions Hospital
Saint Paul
Minnesota
New York Oncology Hematology PC
Albany
New York
Duke University
Durham
North Carolina
FirstHealth Cancer Center
Pinehurst
North Carolina
Guthrie Medical Group
Sayre
Pennsylvania
Tennessee Oncology PLLC - Chattanooga
Chattanooga
Tennessee
Tennessee Oncology, PLLC
Nashville
Tennessee
Virginia Cancer Specialists PC
Fairfax
Virginia
Fundacion Respirar
Ciudad Autonoma de Buenos Aires
Buenos Aires
Instituto de Investigaciones clinicas de Mar del Plata
Mar del Plata
Buenos Aires
Monash Medical Centre
Clayton
Victoria
Austin Health, Austin Hospital
Heidelberg
Victoria
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
Hospital de Clinicas de Porto Alegre
Porto Alegre
Rio Grande do Sul
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre
Rio Grande do Sul
Cipo - Centro Integrado de Pesquisa em Oncologia
Porto Alegre
Rio Grande do Sul
Hospital de Amor
Barretos
São Paulo
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto
São Paulo
Beijing Cancer Hospital
Beijing
Beijing Municipality
Peking Union Medical College Hospital
Beijing
Beijing Municipality
Fujian Cancer Hospital
Fuzhou
Fujian
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou
Fujian
Sun Yat-Sen University Cancer Center
Guangzhou
Guangdong
Affiliated Cancer Hospital of Harbin Medical University
Harbin
Heilongjiang
The Second Xiangya Hospital of Central South University
Changsha
Hunan
Shanxi Bethune Hospital
Taiyuan
Shanxi
West China Hospital of Sichuan University
Chengdu
Sichuan
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Tianjin Municipality
Sir Run Run Shaw Hospital
Hangzhou
Zhejiang
Taizhou Hospital of Zhejiang Province
Taizhou
Zhejiang
Hopital Lyon sud
Pierre-Bénite
France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes
France
Hopital Foch
Suresnes
France
+ 38 more sites — see the full list on the official registry below.
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.
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