Effects of Infusion Timing on Treatment Response in Solid Tumors

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07630168
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Jan 1, 2033
Completion
Jan 1, 2033

Study Design

Enrollment
238 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1A: 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: NSCLC received Anti- PD-1/PD-L1 start after 3:00 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 after 3:00 PM.
  • Experimental: Cohort 2A: HNSCC received Anti- PD-1 start prior 12:00 PM
    Patients with advanced or metastatic locally advanced, resectable HNSCC eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) therapy received treatment before 12:00 PM.
  • Experimental: Cohort 2B: HNSCC received Anti- PD-1 start after 3:00 PM
    Patients with advanced or metastatic locally advanced, resectable HNSCC eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) therapy received treatment after 3:00 PM.

Primary Outcome Measure

Progression free survival (PFS) - non-small cell lung cancer (NSCLC) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIP
University of North Carolina at Chapel Hill, Department of Radiation OncologyChapel HillNorth Carolina27599

Find similar trials in Chapel Hill, NC

By condition
Head and neck cancerLung cancer
By specialty
OncologyENTLung oncologyLung disease
By research site
University of North Carolina at Chapel Hill, Department of Radiation Oncology· Chapel Hill, NC

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