This phase IV trial is evaluating whether the time of day that immune checkpoint inhibitor therapy is administered impacts its effectiveness in treating patients with non-small cell lung cancer or other solid cancers that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that have spread from where they first started (primary site) to other places in the body (metastatic). Immune checkpoint inhibitors, including anti-PD-1 and anti-PD-L1 agents, are common first-line treatment options for patients with advanced or metastatic cancers. Immunotherapy with immune checkpoint inhibitors may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Research has shown that the immune system is affected by the body's circadian rhythm, which is a highly controlled fluctuation in the expression of certain genes that affect the function of the body, responsible for regulating sleep-wake cycles, hormone release, body temperature, and other physical and mental processes. Disruptions to the circadian rhythm have been shown to produce worse disease outcomes in patients with cancer and may affect how patients respond to drugs. The time of day that immune checkpoint inhibitor therapy is administered (early in the day compared to late in the day) may impact its effectiveness in treating patients with advanced or metastatic non-small cell lung cancer or other solid cancers.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07224971.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)Status: Active
Contact: Liza C. Villaruz
Phone: 412-648-6577
PRIMARY OBJECTIVE:
I. To evaluate the real-world progression-free survival (rwPFS) in non-small cell lung cancer (NSCLC) patients who receive first-line immune checkpoint inhibitor (ICI) therapy early in the day (prior to 11AM) versus late in the day (after 12PM) (cohort A).
SECONDARY OBJECTIVES:
I. To evaluate overall survival (OS) in NSCLC patients who receive first-line ICI therapy early in the day (prior to 11AM) versus late in the day (after 12PM) (cohort A).
II. To evaluate the real-world progression-free survival (rwPFS) and OS with maintenance ICI therapy early in the day (prior to 11AM) versus late in the day (after 12PM) in NSCLC patients with stable or response disease after induction therapy (cohort B).
III. To evaluate the real-world progression-free survival (rwPFS) and OS in patients who receive first-line ICI therapy early in the day (prior to 11AM) versus late in the day (after 12PM) across all solid tumor types (cohort C).
IV. To evaluate health related quality of life (HRQoL) based on change in symptoms and function from baseline and over time as assessed by the European Quality of Life Five Dimension Five Level (EQ-5D-5L) questionnaire (All cohorts – A, B, and C).
EXPLORATORY OBJECTIVES:
I. To evaluate pharmacoeconomic parameters at the patient, network and system level (All cohorts – A, B, and C).
II. To evaluate incidence of immune-related adverse events (irAEs) that result in a dose hold or delay in patients treated with first-line ICI therapy in the early group versus (vs.) the late group (All cohorts – A, B, and C).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive anti-PD-1/anti-PD-L1 agent per standard practice at the provider's discretion, with dosing started and completed by 11AM.
ARM II: Patients receive anti-PD-1/anti-PD-L1 agent per standard practice at the provider's discretion, with dosing started after 12PM.
After completion of study treatment, patients are followed up at 90 days and then up to 3 years.
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorLiza C. Villaruz
