RECRUITING Phase 2 ClinicalTrials.gov

Effects of Infusion Timing on Treatment Response in Solid Tumors

Sponsor: UNC Lineberger Comprehensive Cancer Center • ClinicalTrials.gov ID: NCT07630168

Registry updated: 2026-09-15

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Description

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.

Interventions

PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM (Drug)
PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor monotherapy will be administered before 12:00PM for 4 cycles.
PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM (Drug)
PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor monotherapy will be administered after 3 PM for 4 cycles.
PD-1 inhibitor monotherapy - 2 cycles before 12:00PM (Drug)
PD-1 (programmed cell death protein 1) inhibitor monotherapy will be administered before 12:00PM for 2 cycles.
PD-1 inhibitor monotherapy - 2 cycles after 3 PM (Drug)
PD-1 (programmed cell death protein 1) inhibitor monotherapy will be administered after 3 PM for 2 cycles.

Eligibility criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Conditions

Lung Cancer Non-small Cell Lung Cancer Metastatic Lung Cancer Head and Neck Cancer Metastatic Squamous Cell Carcinoma Metastatic Head and Neck Cancer Resectable Head and Neck Squamous-cell Carcinoma

Locations

University of North Carolina at Chapel Hill, Department of Radiation Oncology — Chapel Hill, North Carolina, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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