NCT06882174

This Study is Comparing Morning vs Random Scheduling of Standard of Care Pembrolizumab Checkpoint Inhibitor Immunotherapy Infusions in Patients With Metastatic Non-small Cell Lung Cancer

Timing of Immunotherapy for the Modulation of Efficacy: a Pilot Study in Metastatic Non-Small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is comparing morning infusions of the study drug (pembrolizumab) to random infusion scheduling for patients with non-small cell lung cancer. Participants will be randomized to either the Intervention (Morning Group) where Infusion start times are restricted between 0800 AM and 1000 AM or to the Control (Standard of Care) group where scheduling will occur as standard of care scheduling, in which infusions are scheduled without respect to a specific time of day. There are past studies that suggest the timing of treatment may influence immune response and outcomes. This idea is called chronotherapy. Chronotherapy explores the notion that the timing of drug administration in relation to the body's internal clock can optimize treatment effectiveness. The timing of the infusions for the morning group was therefore, chosen based on data from these past studies that looked at circadian variation in immune system function with the intent to focus on similar infusion windows. The aim of this study is to provide confirmation that the intervention is possible to achieve and use these results to design a larger study. Circadian timing of drug administration, if effective, would represent an intervention that could improve survival outcomes at no additional cost or apparent increase in toxicity, which is truly rare in oncology. Participants are asked to participate in the study intervention for 18 weeks (6 cycles of pembrolizumab), after which participants would continue with ad hoc scheduling as per standard of care.

Conditions

• Metastatic Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Scheduling of the time of pembrolizumab infusions	The intervention in this study is scheduling of the time of pembrolizumab infusions.

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2025-03-18
• Last updated: 2025-12-08