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Monoclonal Antibodies
Pembrolizumab for Lung Cancer
Phase 2 & 3
Recruiting
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be ≥ 18 years of age.
Patients must have a PD-L1 test result from a certified laboratory indicating PD-L1 expression Tumour Proportion Score (TPS) ≥ 1%.
Must not have
Concurrent treatment with other anti-cancer therapy or other investigational anti-cancer agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Summary
This trial is testing whether blood tests can show how well pembrolizumab is working against cancer.
Who is the study for?
Adults with metastatic Non-Small Cell Lung Cancer (NSCLC) who haven't had systemic chemotherapy or immunotherapy for advanced cancer. They must have a PD-L1 expression score of at least 1%, be in good physical condition, and agree to use effective contraception. Not eligible if they've had certain other cancers, are pregnant, have untreated brain metastases requiring steroids, or conditions that pembrolizumab could worsen.
What is being tested?
The trial is testing whether blood tests can effectively monitor the response to pembrolizumab treatment in NSCLC patients. Pembrolizumab is an immunotherapy drug designed to help the body's immune system fight cancer cells.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation of organs like lungs or intestines, skin reactions, hormonal gland problems (like thyroid), fatigue, infusion reactions and may increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My cancer shows a PD-L1 level of 1% or higher.
Select...
I am fully active or can carry out light work.
Select...
My lung cancer is confirmed and has spread, but I can't have surgery or targeted radiation.
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My cancer can be measured by scans according to RECIST 1.1.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not currently receiving any other cancer treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Stage 1: Concordance rate between molecular response and radiologic response
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab + standard platinum-based chemotherapyExperimental Treatment1 Intervention
Per current Product Monograph/U.S. Drug Label and/or local guidelines.
Group II: Pembrolizumab aloneActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070
Find a Location
Who is running the clinical trial?
Mark Foundation for Cancer ResearchUNKNOWN
Cancer Research Institute, New York CityOTHER
20 Previous Clinical Trials
1,069 Total Patients Enrolled
Canadian Cancer Trials GroupLead Sponsor
127 Previous Clinical Trials
68,044 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My recent blood and organ function tests are within normal ranges.I can start treatment within 2 days of joining the trial.I haven't had chemo or immunotherapy for advanced lung cancer but may have had it for earlier stages.I cannot take pembrolizumab due to an active infection, autoimmune disease, need for immunosuppressants, severe immune reactions, or allergy to it.My cancer shows a PD-L1 level of 1% or higher.I am not currently receiving any other cancer treatments.I've had recent scans of my chest, abdomen, pelvis, and brain to document my cancer.My lung cancer does not have EGFR or ALK mutations, or I have squamous cell lung cancer.I had major surgery over 28 days ago and my wound has healed.I had cancer before, but it won't affect this trial's treatment.I have recovered from side effects of my previous cancer treatments.I agree to use birth control if I or my partner can become pregnant.I have brain metastases but am stable on low-dose steroids or have no symptoms.I am fully active or can carry out light work.I can be treated with pembrolizumab and understand it might not be covered everywhere.My lung cancer is confirmed and has spread, but I can't have surgery or targeted radiation.My cancer can be measured by scans according to RECIST 1.1.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab alone
- Group 2: Pembrolizumab + standard platinum-based chemotherapy
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.
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