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Monoclonal Antibodies

Pembrolizumab for Lung Cancer

Ottawa, Canada
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
No Placebo-Only Group

Summary

This trial is testing whether blood tests can show how well pembrolizumab is working against cancer.

See full description
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 am 18 years old or older.
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My cancer shows a PD-L1 level of 1% or higher.
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I am fully active or can carry out light work.
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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.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not currently receiving any other cancer treatments.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

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 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Vomiting
33%
Dysgeusia
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Blood creatinine increased
23%
Oropharyngeal pain
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Asthenia
19%
Oral candidiasis
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Gamma-glutamyltransferase increased
12%
Dysphonia
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Hypophosphataemia
8%
Dizziness
8%
Hiccups
7%
Ear pain
7%
Oral pain
7%
Localised oedema
7%
Urinary tract infection
7%
Hyperkalaemia
7%
Erythema
6%
Abdominal pain upper
6%
Dyspepsia
6%
Saliva altered
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
5%
Oedema peripheral
5%
Back pain
5%
Dyspnoea
5%
Hypertension
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Pneumonia aspiration
3%
Sepsis
3%
Pneumonitis
3%
Trismus
3%
Laryngeal oedema
2%
Cellulitis
2%
Malnutrition
2%
Pharyngeal haemorrhage
1%
Colitis
1%
Mouth haemorrhage
1%
Oesophagitis
1%
Death
1%
General physical health deterioration
1%
Hypersensitivity
1%
Device related infection
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Abscess neck
1%
Bronchitis
1%
Clostridium difficile colitis
1%
Hypercalcaemia
1%
Septic shock
1%
Stoma site infection
1%
Systemic infection
1%
Vascular device infection
1%
Wound infection
1%
Hypophagia
1%
Tumour haemorrhage
1%
Syncope
1%
Cerebrovascular accident
1%
Acute respiratory failure
1%
Aspiration
1%
Pulmonary embolism
1%
Respiratory failure
1%
Acute myocardial infarction
1%
Cardiac arrest
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~2630

Find a Location

Closest Location:Juravinski Cancer Centre at Hamilton Health Sciences· Hamilton, Canada· 1017 miles

Who is running the clinical trial?

Personal Genome DiagnosticsIndustry Sponsor
3 Previous Clinical Trials
1,474 Total Patients Enrolled
Mark Foundation for Cancer ResearchUNKNOWN
Cancer Research Institute, New York CityOTHER
21 Previous Clinical Trials
1,078 Total Patients Enrolled
Canadian Cancer Trials GroupLead Sponsor
133 Previous Clinical Trials
70,082 Total Patients Enrolled
Personal Genome Diagnostics (PGDx)UNKNOWN
1 Previous Clinical Trials
1,320 Total Patients Enrolled
Cheryl HoStudy ChairBCCA - Vancouver Cancer Centre
Sara MooreStudy ChairOttawa Hospital Research Institute
Valsamo AnagnostouStudy ChairJohns Hopkins University

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04093167 — Phase 2 & 3
Non-Small Cell Lung Cancer Research Study Groups: Pembrolizumab alone, Pembrolizumab + standard platinum-based chemotherapy
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
~61 spots leftby Dec 2026
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