Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07630168 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Effects of Infusion Timing on Treatment Response in Solid Tumors

Study acronym: TIMED
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 4 more changesShow less
    • Start date changed from estimate of Aug 1, 2026 to Aug 3, 2026
    • Interventions: PD-1 inhibitor monotherapy - 2 cycles after 3 PM (Drug), PD-1 inhibitor monotherapy - 2 cycles before 12:00PM (Drug), PD-1/PD-L1 inhibitor… to PD-1 inhibitor monotherapy - 2 cycles after 3 PM (Drug), PD-1 inhibitor monotherapy - 2 cycles before 12:00PM (Drug), PD-1/PD-L1 inhibitor…
    • Eligibility criteria expanded, about 12 words
    • Site details revised
  2. Start date: Jun 1, 2026 to Aug 1, 2026
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 1 of 3 entries
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07630168
Lead Sponsor UNC Lineberger Comprehensive Cancer Center
Conditions
(from sponsor)		 Lung Cancer, Non-small Cell Lung Cancer, Metastatic Lung Cancer, Head and Neck Cancer, Metastatic Squamous Cell Carcinoma, Metastatic Head and Neck Cancer, Resectable Head and Neck Squamous-cell Carcinoma
Related terms Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Head and Neck Neoplasms, Lung Neoplasms
Enrollment 238 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov