Trial comparing treatments for Metastatic Non Small Cell Lung Cancer
Official title 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
ClinicalTrials.gov ID: NCT06882174
What this study is testing
What is Pembrolizumab infusion timing study?
An investigational study of the timing of pembrolizumab infusions for metastatic non‑small cell lung cancer.
Also referred to as Pembrolizumab.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether giving the drug in the morning improves how well it works. It also checks if this timing is easy to do.
- Who it's for
- You may be able to join if you have advanced lung cancer that has spread and you are already receiving the drug.
- What's involved
- You will receive the drug at the clinic. If you are in the morning group, you will get it between 8:00 and 10:00 a.m. If you are in the other group, you will get it at any time that works for you. You will have visits every few weeks for the drug and for routine checks.
- Time commitment
- The study lasts 18 weeks, about six drug visits, after which you can keep getting the drug as usual.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with histologic diagnosis mNSCLC with PDL1 staining ≥ 50% on standard of care IHC testing
- Patients must be eligible for treatment with standard-of-care pembrolizumab
- Patients must be 18 years of age or older.
- Patients must be capable of providing consent to enrolment and willing to comply with study, treatment and follow-up.
- Patients with a performance status of Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Oken et al., 1982) will be eligible for...
You likely can't join if
- Concurrent therapy with systemic therapy other than pembrolizumab (such as chemotherapy, targeted therapy, other checkpoint inhibitors, or hormonal...
- Treatment plan includes local therapy such as radiation or surgery.
- Untreated symptomatic brain metastases, or previously treated brain metastases requiring corticosteroids for symptom control.
- Presence of leptomeningeal disease.
- Known history of human immunodeficiency virus (HIV), active Hepatitis B or Hepatitis C.
- Active autoimmune disease that has required systemic treatment in past 12 months (i.e.
See the full eligibility criteria
- Patients with histologic diagnosis mNSCLC with PDL1 staining ≥ 50% on standard of care IHC testing
- Patients must be eligible for treatment with standard-of-care pembrolizumab
- Patients must be 18 years of age or older.
- Patients must be capable of providing consent to enrolment and willing to comply with study, treatment and follow-up.
- Patients with a performance status of Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Oken et al., 1982) will be eligible for enrolment
- Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 7 days prior to the first dose of pembrolizumab.
- Patients of childbearing / reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period.
- Absence of any condition hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial.
- Absolute neutrophil count (ANC) \>1.0
- Platelet count \>100
- Total serum bilirubin \<2x ULN
- AST and ALT \<3x ULN 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)
- Concurrent therapy with systemic therapy other than pembrolizumab (such as chemotherapy, targeted therapy, other checkpoint inhibitors, or hormonal therapy).
- Treatment plan includes local therapy such as radiation or surgery.
- Untreated symptomatic brain metastases, or previously treated brain metastases requiring corticosteroids for symptom control.
- Presence of leptomeningeal disease.
- Known history of human immunodeficiency virus (HIV), active Hepatitis B or Hepatitis C. Testing for HIV, HBV or HCV is not mandatory for enrolment to study but may occur at the discretion of the investigator.
- Active autoimmune disease that has required systemic treatment in past 12 months (i.e. with use of disease modifying agents, requiring \>10mg prednisone or equivalent or other immunosuppressive drugs).
- Participant unwilling to agree to their treatment times being scheduled as per study protocol during the study treatment period (Cycles 1-6).
The study team makes the final eligibility decision.
Where it is enrolling
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Edmonton, Alberta, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.