Study on New Immunotherapy Combinations for Untreated Advanced or Metastatic Non-Small-Cell Lung Cancer

Sponsor: GlaxoSmithKline

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05565378

This clinical trial is testing new combinations of immunotherapy drugs to see if they are more effective than a single immunotherapy drug in treating patients with advanced or metastatic non-small-cell lung cancer (NSCLC) that has not been treated before.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness and safety of new combinations of immunotherapy drugs compared to a single immunotherapy drug in patients with advanced or metastatic non-small-cell lung cancer (NSCLC) that has not been treated before. The study focuses on patients whose tumors have high levels of a protein called PD-L1. The drug being tested is called Belrestotug.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced non-small-cell lung cancer (NSCLC) that cannot be removed by surgery or treated with radiation alone.
  • Have not received any previous treatment for advanced or metastatic NSCLC.
  • Able to provide a recent tumor sample for testing.
  • Tumors must have high levels of PD-L1 (a protein that helps cancer cells hide from the immune system).
  • Have measurable cancer that can be tracked using standard criteria.
  • Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ function as determined by specific medical tests.
  • Female participants who can become pregnant must agree to use effective birth control.

Exclusion Criteria

  • Have specific genetic mutations in the cancer that can be treated with approved therapies.
  • Have had major surgery within the last 4 weeks or significant lung radiation within the last 6 months.
  • Have received any previous treatment with immune checkpoint inhibitors.
  • Have never smoked or smoked fewer than 100 cigarettes in their lifetime.
  • Have had another invasive cancer within the last 5 years, with some exceptions.
  • Have untreated or worsening brain cancer or cancer in the membranes around the brain.
  • Have an autoimmune disease that required treatment in the last 2 years.
  • Are taking medications that suppress the immune system.
  • Have received a live vaccine within 30 days before starting the study.
  • Have a history of lung diseases like pulmonary fibrosis or pneumonitis.
  • Have had heart problems in the last 6 months.
  • Have unstable liver or bile duct disease.
  • Have had a severe infection in the last 4 weeks.
  • Test positive for tuberculosis, HIV, hepatitis B, or hepatitis C.
  • Have advanced cancer that is causing life-threatening complications.
  • Are currently in another clinical trial or have been in one within the last 4 weeks.
  • Have had a tissue or organ transplant.

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