Effects of Infusion Timing on Treatment Response in Solid Tumors
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 15, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Interventions being studied
- Drug: PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM; Drug: PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM; Drug: PD-1 inhibitor monotherapy - 2 cycles before 12:00PM; Drug: PD-1 inhibitor monotherapy - 2 cycles after 3 PM
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Cohort 1A and 1B:
- Participants with metastatic non-small cell lung cancer (NSCLC).
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subject is willing and able to comply with study procedures based on the judgement of the investigator.
- Age ≥ 18 years at the time of consent. Cohort 2A and 2B:
- Participants with resectable head and neck squamous cell carcinoma (HNSCC)
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subject is willing and able to comply with study procedures based on the judgement
- of the investigator.
- Age ≥ 18 years at the time of consent.
- For All Cohorts (1A,1B, 2A, 2B)
- Subject is currently using steroids (prednisone ≥10 mg or its equivalent) and that cannot be discontinued at least 7 days before starting standard of care treatment.
- Prior immune checkpoint inhibitors (ICI) such as programmed cell death protein 1(PD-1) or programmed death-ligand 1 (PD-L1) inhibitor or Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA4) treatment received less than 6 months from the time of screening.
- Subject is participating in another treatment clinical trial.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of North Carolina at Chapel Hill, Department of Radiation OncologyChapel Hill, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 15, 2026. Always confirm current availability with the study team.