Morning or afternoon? new study tests if immunotherapy timing boosts cancer fight
NCT ID NCT07630168
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 4 times
Summary
This study looks at whether getting immunotherapy infusions in the morning versus the afternoon changes outcomes for people with advanced lung cancer or head and neck cancer. About 238 participants will be randomly assigned to morning or afternoon infusions. Researchers will track survival and tumor response over up to 2 years to see if timing makes a difference.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PD-1/PD-L1 inhibitor (immunotherapy)
- What this could lead to
- If timing matters, this could lead to simple scheduling changes that improve how well immunotherapy works for some cancers.
- What could go wrong
- This is a mid-stage trial testing a hypothesis, not a proven treatment. The effect of timing may be small or absent, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 238 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Jan 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of North Carolina at Chapel Hill, Department of Radiation Oncology
RECRUITINGChapel Hill, North Carolina, 27599, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a dental assistant keep cancer Patients' mouths healthier during radiation?
- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Can an Anti-Fibrotic drug shield lungs from radiation after immunotherapy?
- Breath-Tracking sensor aims to sharpen lung cancer scans