Study on How the Timing of Immunotherapy Infusions Affects Treatment in Solid Tumors

Sponsor: UNC Lineberger Comprehensive Cancer Center

Sponsor score: 40

ClinicalTrials ID:NCT07630168

Provider View

This clinical trial is exploring whether the time of day when immunotherapy is given can influence treatment results in patients with advanced or metastatic non-small cell lung cancer (NSCLC) or locally advanced head and neck cancer. The study compares morning and afternoon infusion times to see if there are differences in patient outcomes.

Patient Parameters

Program Overview

The purpose of this study is to find out if the timing of immunotherapy infusions—whether given in the morning or afternoon—affects how well the treatment works for patients with certain types of cancer. The study includes patients with advanced or metastatic non-small cell lung cancer (NSCLC) and those with head and neck cancer that can be surgically removed. Patients are divided into two groups based on their type of cancer. Each group is then randomly assigned to receive their treatment either in the morning or afternoon. The study will track patient outcomes, such as survival and response to treatment, over a period of up to two years.

Eligibility Criteria

Inclusion Criteria

  • For patients with advanced non-small cell lung cancer (NSCLC):

    • Must have metastatic NSCLC.
    • Must provide written consent to participate and allow access to personal health information.
    • Must be willing and able to follow study procedures.
    • Must be 18 years or older.

  • For patients with head and neck cancer:

    • Must have head and neck cancer that can be surgically removed.
    • Must provide written consent to participate and allow access to personal health information.
    • Must be willing and able to follow study procedures.
    • Must be 18 years or older.

Exclusion Criteria

  • Cannot be using steroids (like prednisone 10 mg or more) unless they can be stopped at least 7 days before starting treatment.
  • Cannot have received certain immune therapies (like PD-1 or PD-L1 inhibitors) within 6 months before the study.
  • Cannot be participating in another treatment clinical trial.

Locations

FACILITYZIPCITYSTATE
University of North Carolina at Chapel Hill, Department of Radiation Oncology27599Chapel HillNorth Carolina

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