Tarlatamab for Neuroendocrine Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, tarlatamab, to evaluate its effectiveness against neuroendocrine tumors, a type of cancer originating in hormone-producing cells. Although already approved for certain lung cancers, researchers aim to determine its efficacy for other tumor types and monitor any side effects. This trial suits individuals with advanced neuroendocrine tumors who have not responded to other treatments. Participants must have a specific protein (DLL3) in their tumors, identified through a special test. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received any investigational anticancer therapy within 28 days, chemotherapy or immunotherapy within 21 days, or small molecular inhibitors within 7 days before starting the study treatment.
Is there any evidence suggesting that tarlatamab is likely to be safe for humans?
Research has shown that tarlatamab has been tested in patients with neuroendocrine tumors, and all patients experienced some side effects. These side effects, known as treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs), are common in new cancer treatments. Importantly, the FDA has already approved tarlatamab for a type of lung cancer, indicating that its safety is generally understood and manageable. However, since this study focuses on neuroendocrine tumors, tarlatamab remains experimental for this use. Researchers are still learning about its effects and safety in this specific context.12345
Why do researchers think this study treatment might be promising?
Tarlatamab is unique because it targets neuroendocrine tumors through a novel mechanism of action. While most treatments for these tumors, such as somatostatin analogs and chemotherapy, work by slowing tumor growth or killing rapidly dividing cells, Tarlatamab is an investigational agent that engages the immune system to attack and destroy cancer cells. Researchers are excited about Tarlatamab because its targeted approach could offer a more effective and potentially less toxic alternative to existing therapies, which often come with significant side effects. Additionally, Tarlatamab is administered intravenously, which might enhance its ability to precisely target tumor cells.
What evidence suggests that tarlatamab might be an effective treatment for neuroendocrine tumors?
Research has shown that tarlatamab, which participants in this trial will receive, may help treat certain tumors. In studies, individuals with tumors containing a specific protein called DLL3 responded better to the treatment. Specifically, 22.2% of these patients experienced tumor shrinkage, which is encouraging. Overall, the drug appears promising for individuals with neuroendocrine tumors, especially when this protein is present.12567
Who Is on the Research Team?
Jonathan Goldman, MD
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Are You a Good Fit for This Trial?
Adults with advanced tumors expressing DLL3, including small cell lung cancer and neuroendocrine tumors. Participants must have stage IV disease or inoperable stage III, an ECOG performance status of 0-1, measurable disease per RECIST 1.1 criteria, and adequate organ function. They should have progressed after at least one therapy line if standard care exists for their tumor type.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tarlatamab intravenously until disease progression, death, unacceptable adverse effects, or withdrawal of consent
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tarlatamab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor
Amgen
Industry Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London