Phase
Condition
Small Cell Lung Cancer
Treatment
CRS Mitigation Strategies
Pembrolizumab
Tarlatamab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant has provided informed consent prior to initiation of any study-specificactivities/procedures
Age greater than or equal to 18 years old at the time of signing the informedconsent
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 recurredfollowing platinum-based regimen
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Participants with treated brain metastases are eligible provided they meet definedcriteria
Adequate organ function as defined in protocol
Exclusion
Exclusion Criteria:
History of other malignancy within the past 2 years prior to first dose oftarlatamab with exceptions
Major surgery within 28 days of first dose tarlatamab
Untreated (includes new lesions or progression in previously treated lesions) orsymptomatic brain metastases and leptomeningeal disease (regardless of symptomaticor not).
Prior anti-cancer therapy: at least 28 days must have elapsed between any prioranti-cancer therapy and first dose of tarlatamab with the following exceptions:participants who received conventional chemotherapy are eligible if at least 14 dayshave elapsed and if all treatment-related toxicity has been resolved to Grade lessthan or equal to 1; and prior palliative radiotherapy must have been completed atleast 7 days before the first dose of tarlatamab
Participants who experienced severe, life-threatening or recurrent (Grade 2 orhigher) immune-mediated AEs or infusion-related reactions including those that leadto 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 anyother form of immunosuppressive therapy within 7 days prior to the first dose oftarlatamab
Part C only: history of solid organ transplantation or active autoimmune diseasethat has required systemic treatment within the past 2 years
Participant with symptoms and/or clinical signs and/or radiographic signs thatindicate an acute and/or uncontrolled active systemic infection within 7 days priorto the first dose of investigational product administration
Study Design
Study Description
Connect with a study center
Chris OBrien Lifehouse
Camperdown, New South Wales 2050
AustraliaSite Not Available
Medizinische Universitaet Graz
Graz, 8036
AustriaSite Not Available
Landeskrankenhaus Salzburg
Salzburg, 5020
AustriaSite Not Available
Universitaetsklinikum Salzburg
Salzburg, 5020
AustriaActive - Recruiting
Gustave Roussy
Villejuif, 94805
FranceSite Not Available
Universitaetsklinikum Wuerzburg
Wuerzburg, 97078
GermanySite Not Available
Universitätsklinikum Würzburg
Wuerzburg, 97078
GermanyActive - Recruiting
Comprehensive Cancer Center Mainfranken
Wurzburg, 97080
GermanySite Not Available
Universitätsklinikum Würzburg
Würzburg, 97078
GermanySite Not Available
Prince of Wales Hospital
Shatin, New Territories,
Hong KongSite Not Available
National Cancer Center Hospital East
Kashiwa-shi, Chiba 277-8577
JapanSite Not Available
Research Site
Chuo Ku, Tokyo 104-0045
JapanSite Not Available
National Cancer Center Hospital
Chuo-ku, Tokyo 104-0045
JapanSite Not Available
Wakayama Medical University Hospital
Wakayama-shi, Wakayama 641-8510
JapanSite Not Available
Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
Amsterdam, 1066 CX
NetherlandsSite Not Available
Nederlands Kanker Instituut, Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, 1066 CX
NetherlandsActive - Recruiting
Maastricht Universitair Medisch Centrum
Maastricht, 6229 HX
NetherlandsSite Not Available
Biokinetica SA
Jozefow, 05-410
PolandSite Not Available
Europejskie Centrum Zdrowia Otwock Szpital imienia Fryderyka Chopina
Otwock, 05-400
PolandSite Not Available
Hospital Universitario 12 de Octubre
Sevilla, Andalucía 41013
SpainSite Not Available
Hospital Clinic i Provincial de Barcelona
Barcelona, Cataluña 08036
SpainSite Not Available
Hospital Universitari Vall d Hebron
Barcelona, Cataluña 08035
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainSite Not Available
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
SwitzerlandSite Not Available
Kantonsspital St Gallen
Sankt Gallen, 9007
SwitzerlandSite Not Available
Kantonsspital St Gallen
St. Gallen, 9007
SwitzerlandSite Not Available
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, 80756
TaiwanSite Not Available
Tri-Service General Hospital
Taipei, 11490
TaiwanSite Not Available
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan, 33305
TaiwanSite Not Available
Christie Hospital
Manchester, M20 4BX
United KingdomSite Not Available
City of Hope National Medical Center
Duarte, California 91010
United StatesSite Not Available
Yale New Haven Hospital
New Haven, Connecticut 06510
United StatesSite Not Available
Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
Winship Cancer Institute
Atlanta, Georgia 30322
United StatesSite Not Available
University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United StatesSite Not Available
John Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21287
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202
United StatesSite Not Available
Washington University
Saint Louis, Missouri 63110-1093
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10021
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic
Columbus, Ohio 43210
United StatesSite Not Available
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
University of Pittsburgh Medical Center Cancer Pavillion
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesSite Not Available
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