A Phase 2 interventional study of Scheduling of the time of pembrolizumab infusions in Metastatic Non Small Cell Lung Cancer, sponsored by AHS Cancer Control Alberta. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by AHS Cancer Control Alberta · Phase 2, Interventional, and Treatment
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.
6,491 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,633 are open to participants now.
This study's planned enrollment of 58 is close to the median of 62 across 5,216 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →AHS Cancer Control Alberta is the lead sponsor of 182 studies on the registry; 31 are open to participants now.
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Patients of childbearing / reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.
Hematological:
Renal:
o Serum creatinine \<3x upper limited of normal (ULN)
Hepatic:
Coagulation:
o International Normalized Ratio (INR) \<1.5x ULN (unless patient is receiving anticoagulant therapy and if PT or PTT is within therapeutic range of intended use of anticoagulants)
Exclusion Criteria:
The intervention in this study is scheduling of the time of pembrolizumab infusions. This group will have their infusion start times restricted to between 0800 AM and 1000 AM .
Drug: Scheduling of the time of pembrolizumab infusions
This group will undergo randomized scheduling in which infusions are scheduled without respect to a specific time of day. The start time of each infusion that will occur during the study intervention period will be randomized into 1 of 3 time periods: 1000 AM to 1200 PM, 1201 PM to 1400 PM, and 1401 PM to 1700 PM. Randomization of scheduling in the Standard of Care Group approximates the typical ad hoc scheduling of infusion times done as standard of care, with reduction in potential for bias on the part of those involved in scheduling given the unblinded nature of the intervention. The time windows for the Standard of Care group have been chosen to allow infusions to be scheduled throughout the day without overlap with the specific scheduling window of the Morning Group, in order to simplify interpretation of clinical outcomes.
Drug: Scheduling of the time of pembrolizumab infusions
The intervention in this study is scheduling of the time of pembrolizumab infusions.
Rate of progression free survival at 18 weeks
PFS is defined as the time between the date of treatment initiation and the date of disease progression (determined utilizing RECIST 1.1 criteria) or death (whatever the cause), whichever occurs first. The rate of PFS at 18 weeks will be determined based on the number of participants who remain alive and whose disease has not progressed in each study arm at the 18 weeks imaging assessment. Comparison will be made to the baseline pretreatment computed tomography (CT) +/- magnetic resonance imaging (MRI) scans, to be completed within 6 weeks of treatment start.
Time frame: The rate of PFS at will be analyzed at week 18
Rate of deviation from scheduling intervention
Deviation from the scheduling intervention is defined as having occurred when a pembrolizumab infusion is started outside of the pre-specified time window. The deviation rate will be calculated both for all infusions for all study participants together, and for the infusions occurring for the participants in the individual study arms independently.
Time frame: Analysis of the scheduling intervention deviation rate will occur during the interim analysis (when 20 participants have completed the study intervention period), and ~90 days following completion of the 1-year follow-up period (end of study)
Dropout Rate
Participant drop out is defined as voluntary withdrawal from the study prior to completion of study intervention period (between first pembrolizumab infusion and end-of-study visit at Week 19). The dropout rate will be calculated both for all study participants, and for the participants in the individual study arms independently.
Time frame: Analysis of the dropout rate will occur during the interim analysis (when 20 participants have completed the study intervention period), and ~90 days following completion of the 1-year follow-up period (end of study)
Progression free survival
PFS is defined as the time between the date of treatment initiation and the date of disease progression (determined utilizing RECIST 1.1 criteria) or death (whatever the cause), whichever occurs first. For participants who remain alive and whose disease has not progressed, PFS will be censored on the date of last survival follow-up assessment at \~1 year after initiation of pembrolizumab treatment. PFS will be based on the disease assessment or date of death provided by the investigator.
Time frame: The final analysis of PFS using the Log-Rank method will be scheduled to occur approximately 90 days following completion of the 1-year follow-up period for the final participant enrolled to study (i.e. end of study analysis).
Overall survival
OS is defined as the time between the date of treatment initiation and the date of death (whatever the cause)
Time frame: The analysis of OS using the Log-Rank method will be scheduled to occur approximately 90 days following completion of the ~1-year follow-up period for the final participant enrolled to study (i.e. end of study analysis).
Objective response rate at 18 weeks
Objective response rate (ORR) will be determined utilizing RECIST 1.1 criteria (Eisenhauer et al., 2009). Baseline staging diagnostic imaging will be compared to imaging at 18 weeks.
Time frame: Objective Response Rate will be analyzed at week 18
Treatment-related toxicity
Proportion of patients with all grade or grade 3 or higher treatment related immune-related toxicity as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: The analysis of treatment-related toxicity will be scheduled to occur approximately 90 days following completion of the 1-year follow-up period for the final participant enrolled to study (ie., end-of-study analysis)
Peripheral blood correlates of immune response
Analysis of peripheral blood for peripheral cytokine response and phenotyping of the peripheral immune cell repertoire.
Time frame: Peripheral blood will be collected prior to the initial pembrolizumab treatment, and then prior to each subsequent pembrolizumab infusion during the study intervention period (Week 1, 4, 7, 10, 13, 16, and 19)
Sensitivity analyses
Participants in the Standard of Care randomized scheduling group will have a variable amount of their infusion occur in the morning or afternoon. A sensitivity analysis of PFS using the Log-Rank method will be performed including only those patients from the Standard of Care randomized scheduling group who have more than 25%, and more than 50% of their pembrolizumab infusions occurring after 1400 pm
Time frame: Sensitivity analyses will be performed approximately 90 days following completion of the 1-year follow-up period for the final participant enrolled to study (end-of-study analysis)
No study locations are listed for this record.
Plan to share: No
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Carcinoma, Non-Small-Cell Lung→
AHS Cancer Control Alberta