400 Participants NeededMy employer runs this trial

Tarlatamab for Small Cell Lung Cancer

(DeLLphi-315 Trial)

Recruiting at 8 trial locations
AC
Overseen ByAmgen Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
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 a new method of administering tarlatamab, a potential drug, to individuals with small cell lung cancer that has recurred after chemotherapy. The goal is to determine if administering the treatment as a subcutaneous injection is as effective as intravenous delivery. The trial seeks participants whose lung cancer has returned after one round of platinum-based chemotherapy and who can perform everyday activities without major issues. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that tarlatamab, administered as an injection under the skin, had a good safety record. Patients with advanced small cell lung cancer tolerated it well, with only 13% experiencing severe side effects related to the treatment. Dosing interruptions were few, and no deaths occurred.

In contrast, earlier studies found safety concerns with tarlatamab given through an IV. Specifically, 57% of patients experienced cytokine release syndrome (CRS), a condition where the immune system releases too many proteins into the blood too quickly. This can be serious, so monitoring for symptoms is crucial.

Overall, both forms of tarlatamab have undergone study. While the injection under the skin appears to have a safer profile, the IV form carries certain risks that should be discussed with healthcare providers.12345

Why do researchers think this study treatment might be promising for small cell lung cancer?

Tarlatamab is unique because it targets small cell lung cancer cells by connecting them with the body's T-cells to help destroy the cancer, a mechanism known as a bispecific antibody approach. Most current treatments for small cell lung cancer, like chemotherapy, attack all rapidly dividing cells, which can also harm healthy cells and cause significant side effects. Tarlatamab is being tested in two forms: a subcutaneous (SC) injection and an intravenous (IV) infusion, offering flexibility in how patients receive the treatment. Researchers are excited because this targeted method could mean fewer side effects and improved effectiveness compared to traditional therapies.

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

Research has shown that Tarlatamab effectively fights tumors and improves survival rates in patients with small cell lung cancer (SCLC). Studies have found that it increases survival by about 10% at both two and three years. In this trial, participants will receive Tarlatamab either via subcutaneous (SC) injection or intravenous (IV) infusion. Tarlatamab is commonly used as a second option when the first treatment fails. When combined with other treatments, it has a 71% success rate in reducing or eliminating cancer. The FDA has approved Tarlatamab, confirming its effectiveness for certain conditions.26789

Who Is on the Research Team?

M

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for adults with extensive-stage small cell lung cancer that has come back after treatment with platinum-based chemotherapy. Participants should be in generally good health aside from their cancer.

Inclusion Criteria

I have or had cancer that spread to my brain or spinal cord.
Minimum life expectancy of 12 weeks
I am fully active or restricted in physically strenuous activity only.
See 6 more

Exclusion Criteria

I have a current or past viral infection as defined by the study protocol.
Other Medical Conditions: History of solid organ transplantation
I have received anticancer treatment within the last 30 days.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tarlatamab via subcutaneous injection or intravenous infusion

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tarlatamab

Trial Overview

The study compares two ways of giving the drug tarlatamab—by injection under the skin (subcutaneous) versus through a vein (intravenous)—to see if they work similarly and are safe for people whose cancer returned after initial chemo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Tarlatamab SCExperimental Treatment1 Intervention
Group II: Tarlatamab IVActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amgen

Lead 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

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40839303/

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Tarlatamab, a … showed durable response with promising survival outcomes in patients with previously treated small cell lung cancer

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OS at 2 years and at 3 years was improved by about 10%, with a 3-year OS of 56%. These are numbers that compare favorably to historical outcomes ...

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Tarlatamab, administered as a 10-mg dose every 2 weeks, showed antitumor activity with durable objective responses and promising survival ...

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Tarlatamab showed promising antitumor activity and safety in the phase 2 DeLLphi-301 study in the third-line or later treatment settings for ES-SCLC.

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IMDELLTRA ® (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on ...

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In the pooled safety population, CRS occurred in 57% (268 out of 473) of patients who received tarlatamab-dlle, including 39% last dose.[1]