Tarlatamab for Small Cell Lung Cancer

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Asrar Alahmadi

Must not be taking: Immunosuppressants, Live vaccines

Disqualifiers: Symptomatic brain metastases, Cardiovascular disease, Active CNS disease, Active infection, Autoimmune disease, 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: 4

Duration: Up to 6 months

39 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial tests the effect of tarlatamab in treating patients with small cell lung cancer (SCLC) that has spread from where it first started to other parts of the body (extensive-stage). SCLC is an aggressive cancer which has a low 5-year survival rate. Tarlatamab is a bispecific antibody that can bind to two different antigens at the same time. Tarlatamab binds to DLL3 which is a protein found on the surface of some types of tumor cells, including small-cell lung cancer, and to CD3 which is present on immune system T-cells (a type of white blood cell) and may interfere with the ability of tumor cells to grow and spread. This may increase the length of time to progression (growing, spreading, or getting worse) and help patients with extensive-stage SCLC live longer.

Who Is on the Research Team?

Asrar AlAhmadi, MBBS

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information

* NOTE: HIPAA authorization may be included in the informed consent or obtained separately

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tarlatamab intravenously over 60 minutes on days 1, 8, and 15 of cycle 1, then on days 1 and 15 of remaining cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Up to 6 months

3 visits in cycle 1, 2 visits in subsequent cycles

Safety Assessment

Safety response assessment scan after 4 weeks of starting treatment. Patients with rapid disease progression will immediately start standard of care platinum-based chemotherapy and immune checkpoint inhibitors.

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment completion. Follow-up visits occur at 30 days post-treatment and then every 3 months for up to 2 years.

Up to 2 years

1 visit at 30 days, then every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Tarlatamab

How Is the Trial Designed?

Group I: Treatment (tarlatamab) Experimental Treatment 9 Interventions

Patients receive tarlatamab IV over 60 minutes on days 1, 8, and 15 of cycle 1, then on days 1 and 15 of remaining cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

Asrar Alahmadi

Lead Sponsor

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