Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Scheduling of the time of pembrolizumab infusions · 1 trial · 1 indication
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Intervention (Morning Infusion) | EXPERIMENTAL | 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 . |
| Standard of Care | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Scheduling of the time of pembrolizumab infusions | DRUG | The intervention in this study is scheduling of the time of pembrolizumab infusions. |
Inclusion Criteria: 1. Patients with histologic diagnosis mNSCLC with PDL1 staining ≥ 50% on standard of care IHC testing 2. Patients must be eligible for treatment with standard-of-care pembrolizumab 3. Patients must be 18 years of age or older. 4. Patients must be capable of providing consent to ...
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Pembrolizumab infusion scheduling is being studied for use in metastatic non small cell lung cancer. The investigational approach compares morning versus random scheduling of standard of care pembrolizumab checkpoint inhibitor immunotherapy infusions in patients with this condition.
Avalon GloboCare Corp. (ticker: ALBT) is developing pembrolizumab infusion scheduling. The company is conducting a Phase 2 clinical trial to evaluate this approach in patients with metastatic non small cell lung cancer.
Pembrolizumab infusion scheduling is in Phase 2 clinical development. It is an investigational approach and has not been approved by the FDA. The ongoing trial is active but not yet recruiting participants.
Pembrolizumab infusion scheduling is being evaluated in one Phase 2 clinical trial, NCT06882174. This randomized, active-controlled study compares morning versus random scheduling of standard of care pembrolizumab infusions in patients with metastatic non small cell lung cancer, with a planned enrollment of 58 participants.
Yes, the Phase 2 clinical trial of pembrolizumab infusion scheduling is randomized. It is an active-controlled study, meaning it compares the investigational scheduling approach against standard of care pembrolizumab infusion scheduling, and it is not double blind.