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Immunotherapy Timing for Lung and Head & Neck Cancers

This study is looking at whether the time of day you receive immunotherapy affects how well it works for certain cancers. It's for people with advanced non-small cell lung cancer (NSCLC) or head and neck squamous cell carcinoma (HNSCC). You would receive either a PD-1 or PD-L1 inhibitor (types of immunotherapy) either before noon or after 3 PM for 2 or 4 cycles. Researchers want to see if giving these treatments at different times of day changes how long people live without their cancer getting worse (progression-free survival) or how much the tumor shrinks. The study plans to enroll 238 participants, and it's currently unclear if they are actively recruiting.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 238 participants and will randomly assign them to receive immunotherapy in the morning or afternoon.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
For non-small cell lung cancer, researchers will track progression-free survival for up to 2 years. For head and neck squamous cell carcinoma, they will measure major pathologic response for up to 3 months.

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NCT07630168

Effects of Infusion Timing on Treatment Response in Solid Tumors

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~238 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PMPD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PMPD-1 inhibitor monotherapy - 2 cycles before 12:00PMPD-1 inhibitor monotherapy - 2 cycles after 3 PM

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS) - non-small cell lung cancer (NSCLC)
Measured over Up to 2 years
+1 more outcome measured

Conditions

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

Explore related trials

Head and Neck Squamous Cell CarcinomaLung Non-Small Cell Carcinoma

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Shetal A Patel, MD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center

Who to contact

Adrianna Warner
[email protected]
919-984-0000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

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.

What this trial measures

  • Progression free survival (PFS) - non-small cell lung cancer (NSCLC)Up to 2 years

    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).

  • Major Pathologic Response (MPR) -head and neck squamous cell carcinoma (HNSCC).Up to 3 months

    Major Pathologic Response (MPR) is defined as participant with ≤10% viable tumor in resected tumor tissue in patients with resectable head and neck squamous cell carcinoma (HNSCC).