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Effects of Infusion Timing on Treatment Response in Solid Tumors

NCT07630168 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2026-07-27

No results posted yet for this study

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

Interventions

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Shetal A Patel, MD · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2033-01-01
Completion
2033-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07630168 on ClinicalTrials.gov