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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
In accordance with CCTG policy, protocol treatment with pembrolizumab is to begin within 2 working days of patient enrollment.
Must be ≥ 18 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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I can start treatment within 2 days of joining the trial.
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I am 18 years old or older.
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My recent blood and organ function tests are within normal ranges.
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I haven't had chemo or immunotherapy for advanced lung cancer but may have had it for earlier stages.
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My cancer shows a PD-L1 level of 1% or higher.
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I've had recent scans of my chest, abdomen, pelvis, and brain to document my cancer.
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My lung cancer does not have EGFR or ALK mutations, or I have squamous cell lung cancer.
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I had major surgery over 28 days ago and my wound has healed.
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I have recovered from side effects of my previous cancer treatments.
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I am fully active or can carry out light work.
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I can be treated with pembrolizumab and understand it might not be covered everywhere.
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Stage 1: Concordance rate between molecular response and radiologic response
Stage 2: Phase II Progression-Free Survival (PFS)
Stage 2: Phase III Overall Survival
Secondary outcome measures
Stage 1: Correlate molecular response to RECIST response based on changes in ctDNA levels
Stage 1: Correlate molecular response to overall survival based on changes in ctDNA levels
Stage 1: Correlate molecular response to progression-free survival based on changes in ctDNA levels
+11 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
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
~2010

Find a Location

Who is running the clinical trial?

Personal Genome Diagnostics (PGDx)UNKNOWN
Cancer Research Institute, New York CityOTHER
20 Previous Clinical Trials
1,069 Total Patients Enrolled
Mark Foundation for Cancer ResearchUNKNOWN

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04093167 — Phase 2 & 3
Non-Small Cell Lung Cancer Research Study Groups: Pembrolizumab + standard platinum-based chemotherapy, Pembrolizumab alone
Non-Small Cell Lung Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04093167 — Phase 2 & 3
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04093167 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the most popular indications for Pembrolizumab?

"Pembrolizumab is an immunotherapy medication that can be used to shrink or slow the growth of various types of cancer, such as malignant neoplasms and microsatellite instability high."

Answered by AI

How many people with the medical condition are being asked to participate in this research study?

"Unfortunately, this study is not enrolling patients at the moment. However, it was updated recently on April 7th, 2022. For individuals interested in other studies, there are 2096 trials actively recruiting for nsclc and 1000 pembrolizumab clinical trials also searching for participants."

Answered by AI

Could you please provide an overview of Pembrolizumab's safety record?

"While Phase 2 trials don't have extensive data supporting efficacy, the available information suggests that Pembrolizumab is safe."

Answered by AI

What is the Pembrolizumab research landscape like?

"City of Hope first studied pembrolizumab in 2010 and, since then, there have been 250 completed trials. At the moment, there are 1000 clinical trials underway with many taking place in Hamilton, British Columbia."

Answered by AI

Are we still enrolling patients for this experiment?

"This study is not currently looking for new participants, as seen by the posting and last edit dates. However, there are 2096 other trials for patients with non-small cell lung carcinoma (nsclc) and 1000 trials involving Pembrolizumab that are actively recruiting."

Answered by AI

Are the sites for this trial widely dispersed?

"There are 6 running for this study such as Juravinski Cancer Centre at Hamilton Health Sciences in Hamilton, BCCA - Vancouver Cancer Centre in Vancouver, and The Sidney Kimmel Comprehensive Cancer Centre in Baltimore. Other locations include the Mayo Clinic in Rochester, Seattle Cancer Care Alliance, and Dana-Farber Cancer Institute in Boston."

Answered by AI
~96 spots leftby Dec 2026