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Clinical Trials in the UK / NCT03319940
Active, not recruiting Phase 1

Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

NCT03319940 · tracked via the Priya Life Science UK tracker
Sponsor
Amgen
Phase
Phase 1
Started
2017-12-26
Last updated
2025-11-19

Condition(s) studied

Small Cell Lung Carcinoma

Investigational drug(s) / intervention(s)

TarlatamabPembrolizumabCRS Mitigation Strategies

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)

Trial sites (39)

FacilityCityRegionStatus
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 Taoyuan Taiwan
Christie Hospital Manchester United Kingdom

On this site

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Official registry record

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.

View NCT03319940 on ClinicalTrials.gov ↗ ← All trials in the UK