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Checkpoint Inhibitor
Pembrolizumab Dosing Schedules for Non-Small Cell Lung Cancer
Phase 2
Waitlist Available
Led By Grace K Dy
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 at the time of study treatment initiation.
Plasma creatinine =< 1.5 x institution upper limit of normal (ULN) or estimated glomerular filtration rate (GFR) (measured or calculated with Cockcroft and Gault formula) > 45 ml/min.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is studying how well a more infrequent dosage of an immunotherapy drug works compared to a more frequent dosage in treating patients with non-small cell lung cancer.
Who is the study for?
This trial is for adults with non-small cell lung cancer who can be treated with pembrolizumab, have stable organ function, and an ECOG performance status of <=2. They must have responded to at least 6 months of pembrolizumab treatment without disease progression. Pregnant women or those on high-dose steroids for brain metastases are excluded.Check my eligibility
What is being tested?
The study compares the effectiveness of administering pembrolizumab every 12 weeks versus every 3 weeks in patients with non-small cell lung cancer. The goal is to see if less frequent dosing maintains similar disease control while reducing treatment frequency and costs.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as fatigue, skin reactions, inflammation in organs like lungs or intestines, hormonal gland problems (like thyroid), liver issues, and could potentially worsen existing infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can perform daily activities with minimal assistance.
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My kidney function, measured by creatinine or GFR, is within the normal range.
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I am eligible for pembrolizumab treatment up to the third line.
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My cancer is confirmed as non-small cell lung cancer, not mixed with small cell.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
1-year progression-free survival (PFS)
Secondary outcome measures
Incidence of adverse events
Overall survival
Other outcome measures
Cox regression models in terms of treatment resistance
Length of time on treatment
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (200mg pembrolizumab 12 weeks)Experimental Treatment1 Intervention
Patients receive 200mg pembrolizumab IV over 30 minutes every 12 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (200mg pembrolizumab 3 weeks)Active Control1 Intervention
Patients receive 200mg pembrolizumab IV over 30 minutes every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,849 Total Patients Enrolled
Grace K DyPrincipal InvestigatorRoswell Park Cancer Institute
2 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can perform daily activities with minimal assistance.I haven't had cancer treatment, except for pembrolizumab, in the last 6 months.I have brain metastasis but haven't been treated with steroids and it's stable after radiation.My kidney function, measured by creatinine or GFR, is within the normal range.My cancer responded to treatment before, with no major growth or new issues outside the brain.My liver enzymes are within acceptable limits.I have used high-dose steroids recently for brain metastases or haven't recovered from their side effects.I am eligible for pembrolizumab treatment up to the third line.Your total bilirubin level in the blood needs to be within a certain range, unless you have Gilbert's syndrome, in which case it can be slightly higher.Your hemoglobin level is at least 9 grams per deciliter.I stopped taking pembrolizumab for over a month due to side effects.My cancer is confirmed as non-small cell lung cancer, not mixed with small cell.My tumor has a mutation treatable by FDA-approved drugs.I have been treated with pembrolizumab for 6-15 months before starting this treatment.My cancer has worsened despite treatment with pembrolizumab.I have not had major surgery in the last 14 days.My cancer has spread to the lining of my brain and spinal cord.I do not have any serious infections or uncontrolled medical conditions.I had radiotherapy or gamma knife for cancer outside the brain over 2 weeks ago and have recovered from side effects.Your platelet count is at least 100 billion per liter.Your blood test shows that you have enough infection-fighting white blood cells.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (200mg pembrolizumab 12 weeks)
- Group 2: Arm I (200mg pembrolizumab 3 weeks)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What have been the reported risks associated with Pembrolizumab usage?
"The safety of Pembrolizumab has been assessed as a 2 on the Power scale, since this is a Phase 2 trial. This means that there is some evidence to back up its security but no definitive proof of efficacy yet."
Answered by AI
Is it possible for new participants to join the trial at this point in time?
"According to the information provided by clinicaltrials.gov, this trial is still recruiting patients for participation. It was initially posted on August 13th 2020 and underwent its latest update on September 21st 2022."
Answered by AI
How many people will be participating in this research endeavor?
"Affirmative. Clinicaltrials.gov data substantiates that this investigation is actively recruiting patients, having initially been posted on August 13th 2020 and last updated on September 21st 2022. Around 152 participants need to be recruited from a single centre of care."
Answered by AI
What other research projects have been done that involve Pembrolizumab?
"At the present moment, 961 trials are actively researching pembrolizumab with 122 in their concluding stage of testing. While most studies take place in Houston, Texas, there are 35 731 centres all around America where such research is conducted."
Answered by AI
What maladies can be aided by Pembrolizumab?
"Pembrolizumab is typically employed to target cancerous growths. It may be beneficial towards the treatment of advanced melanoma, microsatellite instability high, and cases where chemotherapy has been unsuccessful."
Answered by AI
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