Effects of Infusion Timing on Treatment Response in Solid Tumors

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. Withi

Trial Details

NCT ID
NCT07630168
Phase
PHASE2
Sponsor
UNC Lineberger Comprehensive Cancer Center
Status
RECRUITING
Cancer Type
Lung Cancer
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
Locations (sample)
  • Chapel Hill, North Carolina, United States|35.9132,-79.05584

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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