Effects of Infusion Timing on Treatment Response in Solid Tumors
Start Date
8/3/2026
Completion Date
1/1/2033
Summary
This study evaluates whether the time of day when immunotherapy is given affects clinical outcomes. It includes patients eligible for PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor treatment who have either advanced or metastatic non-small cell lung cancer (NSCLC) or locally advanced, resectable head and neck squamous cell carcinoma (HNSCC).The study tests the hypothesis that outcomes differ based on infusion timing (morning versus afternoon). Patients are divided into two cohorts by disease type: Cohort 1 includes NSCLC and Cohort 2 includes HNSCC. Within each cohort, patients are randomly assigned to receive infusions in the morning or afternoon, using a 2:1 ratio for NSCLC and a 1:1 ratio for HNSCC. All treatment and disease assessments follow standard medical care, and outcomes such as survival and treatment response are collected from medical records. Patients will be followed for up to 2 years.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM
PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM
PD-1 inhibitor monotherapy - 2 cycles before 12:00PM
PD-1 inhibitor monotherapy - 2 cycles after 3 PM
Conditions
Locations
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina 27599
United States