Impact of Circadian Rhythm on Immunotherapy

This study aims to determine whether morning versus afternoon treatment impacts efficacy of (standard of care) immunotherapy in a broad patient population. Patients with any type of advanced/metastatic malignancy are eligible to enroll in this study, as long as first-line anti-PD-1/PD-L1 immunotherapy is on label for their condition. Participants will then be randomized to either the early treatment group (administration must start and conclude by 11:00 AM +1 hour window) or the late treatment group (administration must start after 12:00 PM).

NCT Number	NCT07224971
Lead Sponsor	Liza Villaruz, MD
Conditions	Advanced/Metastatic NSCLC
Enrollment	350 participants
Start Date	2025-12-02
Primary Completion	2027-05-01 (estimated)
Study Completion	2030-05-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-09