Study on Using Immune Profile to Guide Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) with Immunotherapy

Sponsor: Hackensack Meridian Health

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05715229

Provider View

This clinical trial is exploring how a blood test that measures circulating tumor DNA (ctDNA) can help determine which patients with advanced NSCLC will benefit from immunotherapy alone and which may need both immunotherapy and chemotherapy.

Patient Parameters

Program Overview

The study aims to find out if a blood test that measures circulating tumor DNA (ctDNA) can predict which patients with advanced non-small cell lung cancer (NSCLC) will respond well to immunotherapy alone, and which patients might need a combination of immunotherapy and chemotherapy. This could help tailor treatments to individual patients' needs.

Description

Participants in this study will be randomly assigned to one of two groups. Both groups will start treatment with two immunotherapy drugs: nivolumab, given every three weeks, and ipilimumab, given every six weeks. After five weeks, a blood test called Guardant360 will be used to check the response of the cancer to the treatment. Based on the results, patients in the larger group will continue with a treatment plan tailored to their test results. The study will use CT scans and possibly MRI scans to monitor the cancer's response every 12 weeks until the disease progresses.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with newly diagnosed, untreated Stage IV non-small cell lung cancer (NSCLC).
  • Must have a positive PD-L1 expression of 1% or more.
  • Must have a baseline Guardant360 CDx test before joining the study.
  • Willing to undergo regular ctDNA testing as part of the study.
  • Life expectancy of at least 12 weeks.
  • Must have a measurable tumor that has not been treated with radiation.
  • Completed any prior radiation therapy at least two weeks before joining the study.
  • Good overall health with an ECOG performance score of 0 to 2.
  • Adequate organ function and specific blood test results.
  • Willing to use effective birth control if there is a chance of pregnancy.

Exclusion Criteria

  • Under 18 years old.
  • Unable to provide informed consent.
  • Have specific genetic mutations with available targeted therapies.
  • No detectable ctDNA or very low levels at baseline.
  • Untreated brain metastases.
  • Active or untreated cancer in the brain or spinal cord.
  • Recent major surgery or injury.
  • Other active cancers unless in remission for at least two years.
  • Active autoimmune diseases requiring treatment.
  • Recent use of high-dose steroids or immunosuppressive drugs.
  • Significant heart or lung disease.
  • Active infections like hepatitis B or C.
  • Severe nerve damage or short life expectancy.

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