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Impact of Circadian Rhythm on Immunotherapy for Advanced NSCLC

This study is looking at whether the time of day you receive standard immunotherapy for advanced non-small cell lung cancer (NSCLC) affects how well it works. Researchers want to see if getting your treatment in the morning versus the afternoon makes a difference. The immunotherapy drugs being studied are common ones like pembrolizumab, nivolumab, and others that block the PD-1 receptor on T cells to fight cancer. You could be eligible if you have advanced/metastatic NSCLC and are starting first-line immunotherapy, or if you've had some initial immunotherapy and are continuing with maintenance treatment. The main goal is to see how long patients live without their cancer getting worse (real-world progression-free survival). The study is currently unclear on its recruitment status and plans to enroll 350 participants.

Study design
This is an interventional study where participants will be randomly assigned to receive their immunotherapy either in the early morning or in the afternoon.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, real-world progression-free survival, will be measured for up to 4.5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07224971

Impact of Circadian Rhythm on Immunotherapy

Recruiting
PHASE2Ages 18+InterventionalTreatment
Liza Villaruz, MD
~350 participants
Updated 2025-12-09 on ClinicalTrials.gov
What's tested:Immunotherapy - PD-1 Blocker

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Real-world progression-free survival (rwPFS) - Cohort A
Measured over Up to 4.5 years

Conditions

Advanced/Metastatic NSCLC

Explore related trials

Lung Non-Small Cell CarcinomaSolid Neoplasm

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Liza Villaruz, MD · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center

Who to contact

Jennifer Ruth, RN
[email protected]
412-623-8963
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Cohort A: Advanced/metastatic NSCLC patients for which 1st line PD-1/PD-L1 therapy is on-label either alone or in combination.
Cohort B: Advanced/metastatic NSCLC patients who have completed up to 4 cycles of induction therapy who have stable disease or responsive disease and for which maintenance anti-PD-1/PD-L1 therapy is on-label either alone or in combination.
Cohort C: Advanced/metastatic solid tumor malignancy for which first-line anti-PD-1/PD-L1 therapy is on-label either alone or in combination. 2. Prior and concurrent therapy criteria

What this trial measures

  • Real-world progression-free survival (rwPFS) - Cohort AUp to 4.5 years

    Time from first dose of 1st line treatment to clinician documented clinical disease progression, initiation of new line of therapy, or death from any cause, whichever comes first. Real-world progression-free survival (rwPFS), defined as the time from first dose of 1st line treatment to clinician documented clinical disease progression, initiation of new line of therapy, or death from any cause, whichever came first. Per RECISIT v1.1, Progressive Disease: ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.