Effects of Infusion Timing on Treatment Response in Solid Tumors

NCT07630168 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: LCCC2526-DCT
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

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

Keywords

programmed cell death protein 1; programmed death-ligand 1

Outcome Measures

Primary Outcomes (2)

• Progression free survival (PFS) - non-small cell lung cancer (NSCLC)

  Progression free survival (PFS) will be measured as the time from the date of randomization to the earliest date of radiographic disease progression (PD), as determined by RECIST 1.1, or death from any cause in subjects with advanced or metastatic non-small cell lung cancer (NSCLC).

  Up to 2 years

• Major Pathologic Response (MPR) -head and neck squamous cell carcinoma (HNSCC).

  Major Pathologic Response (MPR) is defined as participant with ≤10% viable tumor in resected tumor tissue in patients with resectable head and neck squamous cell carcinoma (HNSCC).

  Up to 3 months

Secondary Outcomes (3)

• Overall survival (OS) - non-small cell lung cancer (NSCLC)

  Up to 2 years

• Objective Response Rate (ORR) - non-small cell lung cancer (NSCLC)

  Up to 2 years

• Timing of surgery

  Up to 3 months

Study Arms (4)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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 after 3:00 PM.

Drug: PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM

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

EXPERIMENTAL

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.

Drug: PD-1 inhibitor monotherapy - 2 cycles before 12:00PM

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

EXPERIMENTAL

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.

Drug: PD-1 inhibitor monotherapy - 2 cycles after 3 PM

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.

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

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.

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

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.

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

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

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Study Officials

• Shetal A Patel, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrianna Warner

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): January 1, 2033
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)