Study on Tarlatamab for Treating Extensive Stage Small-cell Lung Cancer

Sponsor: Asrar Alahmadi

Sponsor score: 0

ClinicalTrials ID:NCT07423585

Provider View

This clinical trial is exploring the effects of tarlatamab, a new treatment, on patients with small cell lung cancer (SCLC) that has spread throughout the body. Tarlatamab is designed to help the immune system target and fight cancer cells, potentially slowing down the disease and helping patients live longer.

Patient Parameters

Program Overview

This phase II study is testing how well tarlatamab works in treating patients with extensive-stage small cell lung cancer (SCLC), which is a type of aggressive cancer that has spread beyond the lungs. Tarlatamab is a special type of antibody that can attach to cancer cells and immune cells, helping the immune system attack the cancer. The study aims to see if tarlatamab can slow down the progression of the cancer and improve survival rates for patients.

Description

The main goals of this study are to see how many patients with extensive-stage small cell lung cancer (ES-SCLC) can live without their cancer getting worse for at least 6 months when treated with tarlatamab as their first treatment. The study will also check how safe tarlatamab is and what side effects it might cause.

Secondary goals include measuring how well the cancer responds to tarlatamab, how long the response lasts, and how the treatment affects cancer that has spread to the brain. Researchers will also look at overall survival rates and quality of life for patients.

Patients in the study will receive tarlatamab through an IV on specific days of each 28-day cycle. They will have regular scans to monitor their cancer's response to the treatment. If the cancer progresses quickly, patients may switch to standard chemotherapy and immune therapy.

After finishing the study treatment, patients will have follow-up visits for up to 2 years to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of extensive-stage small cell lung cancer (SCLC) that has spread or returned after treatment.
  • Must have measurable cancer according to specific medical criteria.
  • Must have a brain MRI to check for cancer spread to the brain.
  • Must have certain blood counts and organ function levels within specified limits.
  • Must be able to understand and agree to the study procedures.
  • Must provide a sample of tumor tissue for analysis.
  • Must be willing to provide blood samples during the study.

Exclusion Criteria

  • Currently participating in another study or have received another investigational treatment recently.
  • Have another type of cancer that could interfere with the study.
  • Have active or uncontrolled brain metastases or other central nervous system diseases.
  • Have significant heart disease or recent heart problems.
  • Have active infections or require ongoing treatment for infections.
  • Have active hepatitis or HIV infection unless well-controlled.
  • Have a known allergy to tarlatamab or its components.
  • Have received major surgery recently and not fully recovered.
  • Have autoimmune diseases requiring treatment in the past 2 years.
  • Have a history of organ transplantation.
  • Have lung diseases or conditions affecting the lungs.
  • Have psychiatric or substance abuse disorders that could interfere with the study.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have uncontrolled fluid buildup in the body requiring frequent drainage.
  • Have any other significant medical conditions that could pose a risk during the study.

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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