39 Participants NeededMy employer runs this trial

Tarlatamab for Small Cell Lung Cancer

TO
Overseen ByThe Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests tarlatamab, a promising new treatment for individuals with extensively spread small cell lung cancer (SCLC). Tarlatamab aims to enhance the immune system's ability to fight cancer by targeting specific proteins on tumor and immune cells. The goal is to slow disease progression and extend patients' lives. This trial suits those diagnosed with extensive-stage SCLC who have previously undergone systemic chemotherapy and radiation. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering hope for improved outcomes.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

Is there any evidence suggesting that tarlatamab is likely to be safe for humans?

Research has shown that tarlatamab is approved for patients with extensive-stage small cell lung cancer (SCLC) who haven't responded to platinum-based chemotherapy. This approval indicates confidence in its safety for this condition. Previous studies found that tarlatamab generally has a manageable safety profile, though some side effects require attention.

Some patients experienced cytokine release syndrome (CRS), a reaction that can occur when the immune system activates. This was common but usually mild. Another reported side effect is ICANS, a type of neurological issue, which was more frequent during the first treatment cycle. Despite these side effects, proper medical care can manage the treatment's risks.

Overall, while tarlatamab presents some risks, it has shown promising results in treating SCLC, and healthcare providers can manage its safety profile.12345

Why do researchers think this study treatment might be promising?

Tarlatamab is unique because it targets a specific protein called DLL3, which is often found in small cell lung cancer cells but not in healthy cells. Unlike traditional chemotherapy that attacks all rapidly dividing cells, tarlatamab is designed to engage the immune system to specifically recognize and kill cancer cells, potentially leading to fewer side effects. Researchers are excited about this treatment because it represents a targeted approach, potentially offering a new avenue for patients who may not respond well to existing treatments like chemotherapy and radiation.

What evidence suggests that tarlatamab might be an effective treatment for small cell lung cancer?

Research has shown that tarlatamab is a promising treatment for small cell lung cancer (SCLC). In this trial, participants will receive tarlatamab, which studies have demonstrated can extend median survival to 13.6 months, surpassing traditional chemotherapy. Approximately 40% of patients experienced tumor reduction or disappearance after treatment. Tarlatamab aids the body's immune cells in locating and attacking cancer cells. This targeted approach could help patients with extensive-stage SCLC live longer and slow disease progression.34678

Who Is on the Research Team?

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Asrar AlAhmadi, MBBS

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) with extensive-stage small cell lung cancer that has spread, including those whose cancer returned after standard treatment. Participants must have measurable disease and good organ function. People with stable or treated brain metastases may also join.

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.
See 7 more

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

Trial Overview

The study is testing tarlatamab, a new antibody drug designed to help the immune system target and attack small cell lung cancer cells. Patients will receive tarlatamab along with regular monitoring through scans, blood tests, and questionnaires.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment (tarlatamab)Experimental Treatment9 Interventions

Find a Clinic Near You

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 profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Citations

Tarlatamab in Small-Cell Lung Cancer after Platinum ...

Treatment with tarlatamab resulted in significantly longer overall survival than chemotherapy (median, 13.6 months [95% confidence interval {CI} ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40454646/

Tarlatamab in Small-Cell Lung Cancer after Platinum- ...

Treatment with tarlatamab resulted in significantly longer overall survival than chemotherapy (median, 13.6 months [95% confidence interval {CI} ...

Real-World Outcomes of Tarlatamab in Small Cell ...

After a median follow-up of 6.7 months, the overall response rate (ORR) was 42.9% in SCLC patients. Conclusions. Tarlatamab is a promising treatment option for ...

Real-world safety and efficacy of tarlatamab in patients with ...

Tarlatamab (T), a bi-specific T-cell engager, is approved for use in extensive stage SCLC after progression on a platinum-based chemotherapy ...

The Data Behind the FDA Approval of Tarlatamab for ES- ...

But this was a registrational trial, and these 99 patients changed how we treat small cell. It was third-line, it had a response rate of 40%, ...

Safety Evaluation of Tarlatamab in Small-Cell Lung Cancer ...

Due to its action mechanism, tarlatamab exerts a new toxicities profile, needing careful management. Based on these premises, we performed a ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41245307/

Safety, Efficacy, and Central Nervous System Control in ...

Tarlatamab, a bispecific T-cell engager, is approved for use in extensive-stage SCLC after progression on a platinum-based chemotherapy on the basis of the ...

Tarlatamab Safety Varies Between Clinical and Real-World ...

Tarlatamab demonstrated favorable antitumor activity in a small cohort with small cell lung cancer (SCLC), but it was also linked to higher rates of serious ...