Tarlatamab for Lung Cancer

(DeLLphi-308 Trial)

Recruiting in Palo Alto (17 mi)

+28 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Amgen

Must not be taking: Steroids

Disqualifiers: Brain metastases, Leptomeningeal disease, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Tarlatamab for lung cancer?

Research shows that Tarlatamab, a drug that helps the body's immune cells attack cancer cells, has shown promising results in treating small-cell lung cancer, especially in patients whose cancer returned after other treatments. ^{1 2 3 4 5}

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

This trial is for adults over 18 with extensive stage small cell lung cancer (ES-SCLC) that's worsened after platinum-based treatment. They must be fairly active and healthy overall (ECOG status of 0 or 1), have good organ function, and be able to receive injections in the abdomen or thigh.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

I am at least 18 years old or the legal adult age in my country.

I may not have measurable cancer or available tumor tissue, but I have Amgen's approval to participate.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Exploration

Tarlatamab is administered as a subcutaneous injection to explore dosing

8-12 weeks

Dose Expansion

Tarlatamab is administered at the dose deemed safe and tolerable

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tarlatamab (Monoclonal Antibodies)

Trial Overview The study is testing the safety and how well people tolerate Tarlatamab when it's given as a subcutaneous injection, which means it's injected under the skin, typically in areas like the abdomen.

Participant Groups

Group I: Part 2 Dose Expansion Experimental Treatment 1 Intervention

Following the selection of a SC dosing regimen in Part 1, tarlatamab will be administered in Part 2 at the dose deemed safe and tolerable in Part 1.

Group II: Part 1 Dose Exploration Experimental Treatment 1 Intervention

Tarlatamab will be administered as a SC injection in Part 1.

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

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

Tarlatamab is a promising investigational treatment for small cell lung cancer, specifically targeting the delta-like ligand 3 protein, and has shown effectiveness in patients whose cancer progressed after previous therapies.

Despite its potential benefits, there are concerns regarding the administration challenges of tarlatamab, which may affect its acceptance by clinicians and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tarlatamab Shows Promise in SCLC. [2023]

In a phase 2 trial involving 220 patients with previously treated small-cell lung cancer, tarlatamab demonstrated significant antitumor activity, with an objective response rate of 40% in the 10-mg group and 32% in the 100-mg group, indicating its potential as an effective treatment option.

The treatment was generally well-tolerated, with the most common side effects being cytokine-release syndrome, which was mostly mild (grade 1 or 2), and only 3% of patients discontinued due to treatment-related adverse events, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer. Ahn, MJ., Cho, BC., Felip, E., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

AMG 757, a Half-Life Extended, DLL3-Targeted Bispecific T-Cell Engager, Shows High Potency and Sensitivity in Preclinical Models of Small-Cell Lung Cancer. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Tarlatamab Shows Promise in SCLC. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Tarlatamab, a First-in-Class DLL3-Targeted Bispecific T-Cell Engager, in Recurrent Small-Cell Lung Cancer: An Open-Label, Phase I Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Three-Drug Regimen Bests Chemo in NSCLC. [2022]