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NCT07630168 · ClinicalTrials.gov registry record · Phase 2
Effects of Infusion Timing on Treatment Response in Solid Tumors
A Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Not yet
- Registry status
- Phase 2
- Development phase
- 238
- Enrollment target
NCT07630168: Clinical Trial Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT07630168 is a Phase 2 study that has not yet begun recruiting, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 238 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07630168, a Phase 2 study, has not yet begun recruiting, sponsored by UNC Lineberger Comprehensive Cancer Center.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 238 participants
- Enrollment target
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.
Primary Outcome
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).
Interventions
- DRUG PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM
- DRUG PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM
- DRUG PD-1 inhibitor monotherapy - 2 cycles before 12:00PM
- DRUG PD-1 inhibitor monotherapy - 2 cycles after 3 PM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 238 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2033-01-01 |
| Phase | Phase 2 |
What is known before NCT07630168 opens enrollment
NCT07630168 is an interventional study that assigns participants to a tested intervention. The registered 238 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% higher).
The record links to 0 conditions, and to 4 interventions - of which PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM is the first listed.
NCT07630168 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07630168 about?
NCT07630168 is a clinical study titled "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 (NSC...
What is the current status of trial NCT07630168?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 238 participants. The study started on 2026-06-01. Estimated completion is 2033-01-01.
What interventions are being tested in trial NCT07630168?
The interventions under investigation include: PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM (DRUG), PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM (DRUG), PD-1 inhibitor monotherapy - 2 cycles before 12:00PM (DRUG), PD-1 inhibitor monotherapy - 2 cycles after 3 PM (DRUG).
Who is sponsoring clinical trial NCT07630168?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07630168's enrollment target sits among peer trials
238 255th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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