Morning versus afternoon immunotherapy for advanced/metastatic NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 2 study assigns patients to receive standard-of-care anti-PD-1/PD-L1 immunotherapy either in an early-morning window or in a later-day window and follows clinical outcomes. Three cohorts are included: first-line NSCLC, NSCLC on maintenance after induction, and first-line treatment for other advanced solid tumors. Key endpoints include real-world progression-free survival, overall survival, safety, quality of life, and pharmacoeconomic measures. The protocol is implemented at a large regional U.S. cancer center and uses FDA-approved PD-1/PD-L1 agents such as pembrolizumab, nivolumab, cemiplimab, durvalumab, dostarlimab, avelumab, and atezolizumab when on-label.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Cohort Specific Criteria

   * 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

   o Patients should be ICI-naïve (this should be first-line therapy) (Cohorts A and C), or should have received ICI induction therapy and are now eligible for ICI maintenance therapy (Cohort B).
3. Must be willing to be randomized to complete therapy at assigned time of day, which may be early in the morning OR later in the day/into the evening.
4. Must be eligible to receive anti-PD-1/PD-L1 therapy singly or in combination with other FDA-approved agents according to standard of care practices, as determined by the clinical judgment of the investigator but according to approved label indications
5. Must have the ability to understand and the willingness to sign a written informed consent document.
6. Able to read and write in English.

Exclusion Criteria:

1\. Participant unable to receive anti-PD-1/PD-L1 therapy due to prior allergic reactions to therapy or any therapy ingredients.

Where it's running

• UPMC Hillman Cancer Center
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Liza Villaruz, MD — UPMC Hillman Cancer Center
• Study coordinator: Jennifer Ruth, RN
• Email: ruthj2@upmc.edu
• Phone: 412-623-8963

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.