Does the time of day for PD-1/PD-L1 therapy affect response in NSCLC and HNSCC
Official title: Timing of Immunotherapy and Effective Administration (TIMED): Effects of Infusion Timing on Treatment Response in Solid Tumors
Run by UNC Lineberger Comprehensive Cancer Center · NCT07630168 · Data updated 2026-11-12
In people with advanced NSCLC or resectable head and neck cancer, this study tests whether receiving PD-1/PD-L1 therapy in the morning versus the afternoon changes treatment outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 238 (estimated) |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | prednisone, immunotherapy |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Status | Recruiting |
| Started | August 3, 2026 |
| Main results expected | January 1, 2033 |
| Study ends | January 1, 2033 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT07630168 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with metastatic NSCLC (Cohort 1A/1B) or resectable HNSCC (Cohort 2A/2B) eligible for PD-1/PD-L1 inhibitor therapy and able to comply with study procedures.
✕Probably not a fit
Patients who do not respond to PD-1/PD-L1 therapy or who have disease biology not influenced by infusion timing may see no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 trial randomizes patients with metastatic NSCLC or resectable head and neck squamous cell carcinoma to receive PD-1/PD-L1 inhibitor therapy either in the morning or in the afternoon. The goal is to see if infusion timing influences response rates and survival, using standard care procedures for disease assessment. Cohorts are split by cancer type, with a 2:1 allocation for NSCLC and a 1:1 allocation for HNSCC. Treatments are given in defined time windows, and patients are followed for up to two years with outcomes drawn from medical records.
Why it matters
Potential benefit: If successful, scheduling infusions at an optimal time of day could improve responses or survival for patients receiving PD-1/PD-L1 inhibitors.
How similar studies have gone: There is limited prior evidence on circadian timing for immunotherapy; this study explores a relatively novel approach in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion 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. * Age ≥ 18 years at the time of consent. Cohort 2A and 2B: * Participants with resectable head and neck squamous cell carcinoma (HNSCC) * 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. * Age ≥ 18 years at the time of consent. Exclusion Criteria: For All Cohorts (1A,1B, 2A, 2B) * Subject is currently using steroids (prednisone ≥10 mg or its equivalent) and that cannot be discontinued at least 7 days before starting standard of care treatment. * Prior immune checkpoint inhibitors (ICI) such as programmed cell death protein 1(PD-1) or programmed death-ligand 1 (PD-L1) inhibitor or Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA4) treatment received less than 6 months from the time of screening. * Subject is participating in another treatment clinical trial.
Where it's running
-
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Shetal A Patel, MD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Adrianna Warner
- Email: Adrianna_warner@med.unc.edu
- Phone: 919-984-0000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.