Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07423585

Tarlatamab for the Treatment of Extensive Stage Small-cell Lung Cancer

Led by Asrar Alahmadi · Updated on 2026-02-20

39

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

Sponsors

A

Asrar Alahmadi

Lead Sponsor

A

Amgen

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Tarlatamab for the Treatment of Extensive Stage Small-cell Lung Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent and HIPAA authorization
  • Age 18 years or older
  • ECOG performance status of 0 or 2
  • Newly diagnosed extensive-stage small cell lung cancer (SCLC) confirmed by tissue analysis
  • Patients with multiple lung nodules or lymph node involvement too extensive for radiation allowed
  • Recurrent limited-stage SCLC after 6 months from prior chemotherapy and radiation may be considered
  • Measurable disease per RECIST v1.1
  • Brain MRI required; patients with treated, stable brain metastases or asymptomatic untreated metastases may be eligible
  • Absolute neutrophil count ≥ 1500 cells/uL
  • Platelets ≥ 100,000/uL
  • Hemoglobin ≥ 9.0 g/dL
  • Lymphocyte count ≥ 500/uL
  • Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
  • Total bilirubin below specified limits depending on liver status
  • AST, ALT, and alkaline phosphatase below specified multiples of upper normal limits
  • Albumin ≥ 2.5 g/dL
  • Patients with indwelling catheters allowed
  • Baseline oxygen saturation ≥ 90% on room air
  • COPD patients on stable oxygen ≥ 6 months may be eligible
  • Left ventricular ejection fraction ≥ 50% with no significant heart abnormalities
  • Ability to comply with study procedures
  • Availability of archival tumor tissue for analysis
  • Willing to provide blood samples during the study
Not Eligible

You will not qualify if you...

  • Participation in another investigational study or treatment within 4 weeks
  • Prior or concurrent malignancy interfering with study assessments
  • Symptomatic brain metastases or leptomeningeal disease
  • Significant cardiovascular disease within 3 months
  • Active, uncontrolled central nervous system diseases like stroke or epilepsy
  • Active systemic infection requiring parenteral antibiotics
  • Active hepatitis or uncontrolled HIV infection
  • Known allergy to tarlatamab components
  • Prior SCLC treatment except certain limited-stage cases after 6 months
  • Major surgery within 30 days without recovery
  • Active autoimmune diseases requiring systemic therapy
  • History of organ transplantation
  • Interstitial lung disease or active pneumonitis
  • Psychiatric or substance abuse disorders interfering with study participation
  • Recent live vaccinations or SARS-CoV-2 vaccine during screening
  • Unwillingness to use effective birth control during and after study
  • Symptomatic fluid accumulations needing frequent drainage
  • Uncontrolled respiratory symptoms or impending respiratory failure
  • Any condition posing safety risk or interfering with study completion as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

T

The Ohio State University Comprehensive Cancer Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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