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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07630168
The ClinicalTrials.gov registry entry for NCT07630168 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 238 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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