Tarlatamab for Neuroendocrine Tumors

Recruiting at 3 trial locations

Overseen By Ruth Gonzalez

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Jonsson Comprehensive Cancer Center

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: SCLC, NEPC, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

29 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being done to learn more about the drug tarlatamab in people with your condition. The purpose of this study is to see the efficacy (how well something works) of study treatment (tarlatamab) and whether it causes any side effects. Tarlatamab is being developed as an anti-cancer drug for tumors and is FDA-approved for extensive-stage small cell lung cancer. Tarlatamab is investigational for the purpose of this study.

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.

What makes the drug Tarlatamab unique for treating neuroendocrine tumors?

Tarlatamab is unique because it represents a novel approach in the treatment of neuroendocrine tumors, potentially offering a new mechanism of action compared to existing therapies like somatostatin analogues and targeted therapies such as sunitinib and everolimus. While traditional treatments focus on hormone control and targeting specific receptors, Tarlatamab may provide an innovative option, especially for patients who do not respond to current standard treatments. ^{1 2 3 4 5}

Research Team

Jonathan Goldman, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

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

My cancer is confirmed stage IV, or stage III and not suitable for surgery or radiotherapy.

I am fully active or can carry out light work.

Participant has provided informed consent prior to initiation of any study specific activities/procedures

Exclusion Criteria

I haven't taken steroids or immunosuppressants in the last week.

I haven't had any other cancer besides this one in the last 2 years.

I haven't received any live vaccines in the last 14 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tarlatamab intravenously until disease progression, death, unacceptable adverse effects, or withdrawal of consent

18 months

Regular visits for IV administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Treatment Details

Interventions

• Tarlatamab

Trial Overview The trial is testing the efficacy and safety of tarlatamab as a treatment for cancers that express the protein DLL3. Tarlatamab is an investigational anti-cancer drug approved for extensive-stage small cell lung cancer but being studied further in this trial.

Participant Groups

Group I: Tarlatamab treatment Experimental Treatment 1 Intervention

Tarlatamab will be administered as a 60-minute intravenous (IV)

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Amgen

Industry Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

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

Findings from Research

In a study involving 242 patients with advanced neuroendocrine tumors treated with surufatinib, the presence of treatment-related adverse events (TRAEs) like hypertension, proteinuria, and hemorrhage in the first 4 weeks was linked to a longer progression-free survival (PFS) of 11.1 months compared to 9.2 months for those without these events.

The findings suggest that TRAEs could serve as potential biomarkers for predicting the efficacy of surufatinib treatment, indicating that patients experiencing these side effects may have better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment-related adverse events as predictive biomarkers of efficacy in patients with advanced neuroendocrine tumors treated with surufatinib: results from two phase III studies. Li, J., Cheng, Y., Bai, C., et al.[2022]

References

1. Hungary pubmed.ncbi.nlm.nih.gov

[Pharmacologic therapy for neuroendocrine tumours]. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Treatment-related adverse events as predictive biomarkers of efficacy in patients with advanced neuroendocrine tumors treated with surufatinib: results from two phase III studies. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Targeted Cancer Therapy: What's New in the Field of Neuroendocrine Neoplasms? [2021]

4. Italy pubmed.ncbi.nlm.nih.gov

New drugs in the therapy of neuroendocrine tumors. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Emerging Treatment Options for Gastroenteropancreatic Neuroendocrine Tumors. [2020]