Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)
NCT ID: NCT03319940
Last Updated: 2025-11-19
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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ACTIVE_NOT_RECRUITING
PHASE1
269 participants
INTERVENTIONAL
2017-12-26
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part A
Tarlatamab monotherapy
Tarlatamab
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
Part C
Tarlatamab with Pembrolizumab
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
Part D
Tarlatamab with additional CRS mitigation strategies
Tarlatamab
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
CRS Mitigation Strategies
Participants will be treated with one of the CRS mitigation strategies.
Part E
Tarlatamab administration with 24-hour monitoring
Tarlatamab
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
Part F
Tarlatamab administered in outpatient infusion centers with 8-hour monitoring
Optional wearable digital device substudy (US sites only)
Tarlatamab
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
Part G
Tarlatamab additional dosing schedule
Optional wearable digital device substudy (US sites only)
Tarlatamab
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 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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City of Hope National Medical Center
Duarte, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
John Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic
Columbus, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Cancer Pavillion
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia
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, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, Japan
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, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain
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
Taoyuan District, , Taiwan
Christie Hospital
Manchester, , United Kingdom
Countries
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References
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Owen DH, Giffin MJ, Bailis JM, Smit MD, Carbone DP, He K. DLL3: an emerging target in small cell lung cancer. J Hematol Oncol. 2019 Jun 18;12(1):61. doi: 10.1186/s13045-019-0745-2.
Dowlati A, Hummel HD, Champiat S, Olmedo ME, Boyer M, He K, Steeghs N, Izumi H, Johnson ML, Yoshida T, Bouchaab H, Borghaei H, Felip E, Jost PJ, Gadgeel S, Chen X, Yu Y, Martinez P, Parkes A, Paz-Ares L. Sustained Clinical Benefit and Intracranial Activity of Tarlatamab in Previously Treated Small Cell Lung Cancer: DeLLphi-300 Trial Update. J Clin Oncol. 2024 Oct 10;42(29):3392-3399. doi: 10.1200/JCO.24.00553. Epub 2024 Aug 29.
Paz-Ares L, Champiat S, Lai WV, Izumi H, Govindan R, Boyer M, Hummel HD, Borghaei H, Johnson ML, Steeghs N, Blackhall F, Dowlati A, Reguart N, Yoshida T, He K, Gadgeel SM, Felip E, Zhang Y, Pati A, Minocha M, Mukherjee S, Goldrick A, Nagorsen D, Hashemi Sadraei N, Owonikoko TK. Tarlatamab, a First-in-Class DLL3-Targeted Bispecific T-Cell Engager, in Recurrent Small-Cell Lung Cancer: An Open-Label, Phase I Study. J Clin Oncol. 2023 Jun 1;41(16):2893-2903. doi: 10.1200/JCO.22.02823. Epub 2023 Jan 23.
Chiang AC, Olmedo Garcia ME, Carlisle JW, Dowlati A, Reguart N, Felip E, Jost PJ, Steeghs N, Stec R, Gadgeel SM, Loong HH, Jiang W, Hamidi A, Parkes A, Paz-Ares L. Safety of tarlatamab with 6-8-h outpatient versus 48-h inpatient monitoring during cycle 1: DeLLphi-300 phase 1 substudy. ESMO Open. 2025 Apr;10(4):104538. doi: 10.1016/j.esmoop.2025.104538. Epub 2025 Apr 4.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20160323
Identifier Type: -
Identifier Source: org_study_id
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