Effects of Infusion Timing on Treatment Response in Solid Tumors

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• 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.

Randomized · Parallel · masking: None

Main goals

• Progression free survival (PFS) - non-small cell lung cancer (NSCLC) (Up to 2 years)
• Major Pathologic Response (MPR) -head and neck squamous cell carcinoma (HNSCC). (Up to 3 months)

Other goals

• Overall survival (OS) - non-small cell lung cancer (NSCLC)
• Objective Response Rate (ORR) - non-small cell lung cancer (NSCLC)
• Timing of surgery

Planned enrollment: 238 (estimated).

• University of North Carolina at Chapel Hill, Department of Radiation Oncology, Chapel Hill, North Carolina

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07630168

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 14, 2026. Public record; not medical advice.