Pilot Study Comparing Different Health Status Groups in Non-Small Cell Lung Cancer Patients Treated with Chemo/Immunotherapy

Sponsor: Wake Forest University Health Sciences

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04253964

Provider View

This study is exploring whether patients with a lower health status (Performance Status 2) can safely and effectively receive the same chemo/immunotherapy treatment as those with a higher health status (Performance Status 0-1) for non-small cell lung cancer.

Patient Parameters

Program Overview

The aim of this study is to see if patients with a lower health status (Performance Status 2) can have similar outcomes in terms of survival and safety when treated with the same first-line immunotherapy-based regimen as patients with a higher health status (Performance Status 0-1). Researchers will compare how long patients live without the cancer getting worse, overall survival, and the side effects experienced by both groups.

Description

The main goal of this study is to show that patients with a lower health status (Performance Status 2) can live without their cancer getting worse for 12 weeks, just like those with a higher health status (Performance Status 0-1).

Secondary goals include:

  • Ensuring that the side effects experienced by the lower health status group are not worse than those experienced by the higher health status group after 12 weeks.
  • Checking that the overall quality of life and health status of the lower health status group is not worse than that of the higher health status group after 12 weeks.
  • Making sure that symptoms specific to lung cancer do not worsen more in the lower health status group compared to the higher health status group after 12 weeks.

Eligibility Criteria

Inclusion Criteria

  • Must have non-small cell lung cancer that has spread or cannot be removed by surgery, with no standard cure available.
  • No previous chemotherapy or immunotherapy for non-curative purposes, but may have had treatment for early-stage disease.
  • Must be at least 18 years old.
  • Must have a health status score of 0-2, as determined by a doctor.
  • Must have a life expectancy of more than 3 months.
  • Must have cancer that can be measured by scans.
  • Must have normal organ and bone marrow function, including:
    • Neutrophil count of at least 1,000/mcL
    • Platelet count of at least 100,000/mcL
  • Women and men must agree to use effective birth control during the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cancer with specific genetic changes that require targeted therapy.
  • Active autoimmune disease needing treatment in the past 2 years.
  • History of lung inflammation needing steroid treatment.
  • Uncontrolled illnesses like infections, heart failure, or mental health issues that affect study participation.
  • Pregnant or breastfeeding women due to potential risks from chemotherapy.

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