Tarlatamab: Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
Pembrolizumab: Pembrolizumab is a potent humanized IgG4 monoclonal antibody (mAb) with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2
CRS Mitigation Strategies: Participants will be treated with one of the CRS mitigation strategies.
Study summary
A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Participant has provided informed consent prior to initiation of any study-specific activities/procedures
* Age greater than or equal to 18 years old at the time of signing the informed consent
* Histologically or cytologically confirmed SCLC. For parts A, C, D, E, F, and G: relapsed/refractory small cell lung cancer (R/R SCLC) who progressed or recurred following platinum-based regimen
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Participants with treated brain metastases are eligible provided they meet defined criteria
* Adequate organ function as defined in protocol
Exclusion Criteria:
* History of other malignancy within the past 2 years prior to first dose of tarlatamab with exceptions
* Major surgery within 28 days of first dose tarlatamab
* Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease (regardless of symptomatic or not).
* Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of tarlatamab with the following exceptions: participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade less than or equal to 1; and prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab
* Participants who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated AEs or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents
* Has evidence of interstitial lung disease or active, non-infectious pneumonitis
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab
* Part C only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years
* 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 investigational product administration
Primary outcome measure(s)
Number of participants with dose limiting toxicities (DLT) for all indications — 6 months
Number of participants with treatment-emergent adverse events (AEs) for all indications — 4 years
Number of participants with treatment-related AEs for all indications — 4 years
Number of participants with clinically significant changes in vital signs for all indications — 4 years
Number of participants with significant changes in electrocardiogram (ECG) for all indications — 4 years
Number of participants with significant changes in physical examinations for all indications — 4 years
Number of participants with significant changes in clinical laboratory tests for all indications — 4 years
Trial sites (39)
Facility
City
Region
Status
City of Hope National Medical Center
Duarte
California
Yale New Haven Hospital
New Haven
Connecticut
Moffitt Cancer Center
Tampa
Florida
Winship Cancer Institute
Atlanta
Georgia
University of Chicago
Chicago
Illinois
Ochsner Clinic Foundation
New Orleans
Louisiana
John Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore
Maryland
Henry Ford Health System
Detroit
Michigan
Washington University
St Louis
Missouri
Memorial Sloan Kettering Cancer Center
New York
New York
University Hospitals Cleveland Medical Center
Cleveland
Ohio
The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic
Columbus
Ohio
Fox Chase Cancer Center
Philadelphia
Pennsylvania
University of Pittsburgh Medical Center Cancer Pavillion
Pittsburgh
Pennsylvania
Sarah Cannon Research Institute
Nashville
Tennessee
Chris OBrien Lifehouse
Camperdown
New South Wales
Medizinische Universitaet Graz
Graz
Austria
Landeskrankenhaus Salzburg
Salzburg
Austria
Gustave Roussy
Villejuif
France
Universitaetsklinikum Wuerzburg
Würzburg
Germany
Prince of Wales Hospital
Shatin, New Territories
Hong Kong
National Cancer Center Hospital East
Kashiwa-shi
Chiba
National Cancer Center Hospital
Chuo-ku
Tokyo
Wakayama Medical University Hospital
Wakayama
Wakayama
Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
Amsterdam
Netherlands
Maastricht Universitair Medisch Centrum
Maastricht
Netherlands
Biokinetica SA
Józefów
Poland
Europejskie Centrum Zdrowia Otwock Szpital imienia Fryderyka Chopina
Otwock
Poland
Hospital Universitari Vall d Hebron
Barcelona
Catalonia
Hospital Clinic i Provincial de Barcelona
Barcelona
Catalonia
Hospital Universitario Ramon y Cajal
Madrid
Spain
Hospital Universitario 12 de Octubre
Madrid
Spain
Hospital Universitario La Paz
Madrid
Spain
Centre Hospitalier Universitaire Vaudois
Lausanne
Switzerland
Kantonsspital St Gallen
Sankt Gallen
Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Taiwan
Tri-Service General Hospital
Taipei
Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
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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