Recruiting

Phase 2

PD-1 & PD-L1Effects of Infusion Timing on Treatment Response in Solid Tumors

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT07630168

Conditions

Lung Cancer

Non-small Cell Lung Cancer

Metastatic Lung Cancer

Head and Neck Cancer

Metastatic Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Details

Brief 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.

Conditions

Lung Cancer

Non-small Cell Lung Cancer

Metastatic Lung Cancer

Head and Neck Cancer

Metastatic Squamous Cell Carcinoma

Study ID

NCT07630168

Start date

Aug 3, 2026

Status verified date

Sep, 2026

Completion date

Jan 1, 2033

Anticipated

Primary completion date

Jan 1, 2033

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

238 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1A: non-small cell lung cancer (NSCLC) received Anti- PD-1/PD-L1 start prior 12:00 PM

Patients with advanced or metastatic non-small cell lung cancer (NSCLC) eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) therapy received treatment before 12:00 PM.

experimental: Cohort 1B: non-small cell lung cancer (NSCLC) received Anti- PD-1/PD-L1 start after 3:00 PM

experimental: Cohort 2A: head and neck squamous cell carcinoma (HNSCC) received Anti- PD-1 start prior 12:00 PM

Patients with advanced or metastatic locally advanced, resectable head and neck squamous cell carcinoma (HNSCC) eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) therapy received treatment before 12:00 PM.

experimental: Cohort 2B: head and neck squamous cell carcinoma (HNSCC) received Anti- PD-1 start after 3:00 PM

Patients with advanced or metastatic locally advanced, resectable head and neck squamous cell carcinoma (HNSCC)eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) therapy received treatment after 3:00 PM.

Interventions

PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM

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

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

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

PD-1 (programmed cell death protein 1) inhibitor monotherapy will be administered after 3 PM for 2 cycles.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Adrianna Warner

919-984-0000 Adrianna_warner@med.unc.edu

Locations

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

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Adrianna Warner

919-984-0000 Adrianna_warner@med.unc.edu

Principal Investigator:

Shetal A Patel, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Keywords

programmed cell death protein 1
programmed death-ligand 1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-09-15.