Study on Low-Dose Radiation, Ipilimumab, and Nivolumab Before Surgery for Non-Small Cell Lung Cancer

Sponsor: Brown University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04933903

Provider View

This clinical trial is testing a combination of low-dose radiation therapy with the drugs ipilimumab and nivolumab before surgery in patients with certain stages of non-small cell lung cancer (NSCLC). The study aims to see if this approach can improve the response to treatment and is safe for patients.

Patient Parameters

Program Overview

The purpose of this study is to evaluate whether a combination of low-dose stereotactic body radiation therapy (SBRT) with the drugs ipilimumab and nivolumab, given before surgery, can help control non-small cell lung cancer (NSCLC) in patients with stages IB to III. The main goal is to see how well the cancer responds to this treatment before surgery. The study will also look at the safety of the treatment and explore how the immune system responds before and after the treatment. Only patients who proceed to surgery will be evaluated for the main outcomes.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with non-small cell lung cancer (NSCLC).
  • Age over 18 years.
  • Good overall health with a performance status score of 0 or 1.
  • Lung function must be sufficient to tolerate surgery, with specific lung capacity requirements.
  • Cancer must be at a stage that can be surgically removed (stages IB to IIIB) and deemed operable by a thoracic surgeon.
  • No previous radiation treatment to the chest.
  • Adequate blood cell counts and organ function, including:
    • White blood cells of at least 2,000/mcL.
    • Neutrophil count of at least 1,000/mcL.
    • Platelet count of at least 100,000/mcL.
    • Hemoglobin level above 8.0 g/dL.
    • Normal liver and kidney function tests.
  • Able to provide informed consent or have a representative who can do so.
  • Not pregnant or nursing, with women of childbearing potential agreeing to use effective birth control during the study and for five months after the last dose.
  • Men must agree to use contraception during the study and for seven months after the last dose.

Exclusion Criteria

  • Have a different type of cancer than non-small cell lung cancer.
  • Have received prior radiation treatment to the chest.
  • Have significant health issues that would increase the risk of surgery.
  • Not able to provide informed consent or have a representative who can do so.
  • Pregnant or nursing women.
  • Not willing to use effective birth control during and after the study as required.

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