Impact of Circadian Rhythm on Immunotherapy

Conditions

• Advanced/Metastatic NSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Immunotherapy - PD-1 Blocker — 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

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).

Key Dates

Start date

Dec 2, 2025

Status verified

Dec 2025

Primary completion

May 1, 2027

Completion

May 1, 2030

Study Design

Enrollment

350 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Early Immunotherapy dosing
  NSCLC and solid tumor patients who receive first-line or ICI therapy early in the day (prior to 11AM) versus late in the day (after 12PM) and NSCLC patients with stable or response disease after induction therapy receiving maintenance ICI therapy early in the day (prior to 11AM) versus late in the day (after 12PM)
• Active Comparator: Late Immunotherapy dosing
  NSCLC and solid tumor patients who receive first-line or ICI therapy late in the day (started after 12 PM) and NSCLC patients with stable or response disease after induction therapy receiving maintenance ICI therapy late in the day (started after 12PM)

Primary Outcome Measure

Real-world progression-free survival (rwPFS) - Cohort A [ Time Frame: Up to 4.5 years ]

Central Contacts

• Jennifer Ruth, RN
  412-623-8963
  [email protected]

Locations (1)

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