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Advanced/Metastatic NSCLCSleepDrugPhase 2

What this study is

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).

What's being tested

  • Immunotherapy - PD-1 Blocker

    Intervention · DRUG

    Standard of Care Drugs (at investigator's discretion) may include: pembrolizumab, nivolumab, cemiplimab, durvalumab, dostarlimab, avelumab, and atezolizumab, or other immune checkpoint inhibitors used in cancer treatment that targets cancer cells by blocking the PD-1 receptor on T cells.

Study details

Official title
Assessing the Impact of Circadian Rhythm on Anti-PD-1/PD-L1 Immunotherapy
Sponsor
Liza Villaruz, MD
Conditions
Advanced/Metastatic NSCLC
Enrolling
350 people
Starts
2025-12-02
Est. completion
2030-05-01
Design
Open-label, randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗