Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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 | Taoyuan | Taiwan | |
| Christie Hospital | Manchester | United Kingdom |
On this site
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Other trials for the same condition
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 Poland