Your session is about to expire
← Back to Search
Chemotherapy
Pembrolizumab + Chemotherapy ± Canakinumab for Non-Small Cell Lung Cancer (CANOPY-1 Trial)
Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.
Histologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment and up to 18 months
Awards & highlights
CANOPY-1 Trial Summary
This trial is testing a new cancer treatment that combines two drugs, one that helps the chemotherapy work better and one that fights the cancer cells directly. The goal is to see if this new treatment is more effective and has fewer side effects than current treatments.
Who is the study for?
This trial is for adults with advanced stage IIIB or IV non-squamous and squamous NSCLC who haven't had treatment before. They should have a performance status of 0 or 1, meaning they're fully active or restricted in physically strenuous activity but can do light work. No prior immunotherapy, drugs like canakinumab, certain genetic mutations (EGFR/ALK), compromised immune systems, recent vaccinations/surgeries/radiotherapy, or untreated brain metastases.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of pembrolizumab combined with platinum-based chemotherapy plus canakinumab versus placebo. It's a phase III trial where participants are randomly assigned to receive either the drug combo with canakinumab or without it (placebo) to compare outcomes.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting organs, infusion-related symptoms from the drug entering your body through veins, fatigue, nausea from chemotherapy agents like cisplatin and paclitaxel; blood disorders may also occur due to pembrolizumab.
CANOPY-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My lung cancer is at an advanced stage but hasn't been treated yet.
CANOPY-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment and up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment and up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Double-blind, randomized, placebo-controlled part: Overall survival (OS) per investigator assessment using RECIST v1.1
Double-blind, randomized, placebo-controlled part: Progression free survival (PFS) per investigator assessment using RECIST v1.1
Safety run-in part: Incidence of dose limiting toxicities (DLTs)
Secondary outcome measures
Double-blind, randomized, placebo-controlled part : : Plasma pemetrexed concentration
Double-blind, randomized, placebo-controlled part : Antidrug antibodies (ADA) of canakinumab
Double-blind, randomized, placebo-controlled part : Antidrug antibodies (ADA) of pembrolizumab
+24 moreSide effects data
From 2022 Phase 3 trial • 1274 Patients • NCT0222089412%
Weight decreased
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
9%
Decreased appetite
9%
Arthralgia
9%
Constipation
9%
Haemoptysis
9%
Diarrhoea
9%
Hypothyroidism
9%
Nasopharyngitis
9%
Bronchitis
6%
Cough
6%
Asthenia
6%
Pruritus
6%
Anaemia
6%
Pneumonia
6%
Headache
6%
Blood alkaline phosphatase increased
3%
Rash
3%
Leukopenia
3%
Malaise
3%
Hyperglycaemia
3%
Pneumonia bacterial
3%
White blood cell count decreased
3%
Myalgia
3%
Hypertension
3%
Pyrexia
3%
Hyperthyroidism
3%
Upper respiratory tract infection
3%
Dyspnoea
3%
Chest pain
3%
Subdural haemorrhage
3%
Lymph gland infection
3%
Tumour associated fever
3%
Nausea
3%
Back pain
3%
Haematemesis
3%
Upper gastrointestinal haemorrhage
3%
Oedema peripheral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab Second Course
Pembrolizumab
Chemotherapy (SOC Treatment)
CANOPY-1 Trial Design
2Treatment groups
Experimental Treatment
Group I: canakinumab matching-placeboExperimental Treatment7 Interventions
canakinumab matching-placebo in combination with pembrolizumab and platinum-based doublet chemotherapy
Group II: canakinumabExperimental Treatment7 Interventions
canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
paclitaxel
1996
Completed Phase 3
~4310
cisplatin
1997
Completed Phase 3
~3290
pembrolizumab
2017
Completed Phase 3
~5750
canakinumab
2014
Completed Phase 3
~280
nab-paclitaxel
2008
Completed Phase 4
~1330
carboplatin
2010
Completed Phase 3
~4790
pemetrexed
2005
Completed Phase 3
~5000
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,196,720 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with canakinumab or similar drugs.My PD-L1 status is known from a biopsy tested by a specific lab.I am fully active or restricted in physically strenuous activity but can do light work.You have at least one specific type of visible abnormality that can be measured according to certain guidelines.My cancer has specific changes in the EGFR gene or ALK rearrangement.I have brain metastases or lepto-meningeal disease that hasn't been treated.I have a weakened immune system or an infection.I haven't had major surgery or certain vaccinations and treatments within the specified time frames before starting the study drug.My lung cancer is at an advanced stage but hasn't been treated yet.I have received immunotherapy targeting specific immune pathways before.
Research Study Groups:
This trial has the following groups:- Group 1: canakinumab
- Group 2: canakinumab matching-placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 other pembrolizumab research is available for our review?
"The first clinical trial for pembrolizumab was 2652 completed studies ago, at City of Hope Comprehensive Cancer Center. As of now, there are 2439 open studies with many of them taking place in Boston, Massachusetts."
Answered by AI
What are some of the most well-known treatments that pembrolizumab is used for?
"Pembrolizumab is frequently used to treat malignant neoplasms but can also help patients with other conditions like unresectable melanoma, microsatellite instability high, and neonatal-onset multisystem inflammatory disease (NOMID)."
Answered by AI
Are patients still being signed up for this trial?
"As of right now, this trial is not looking for any new candidates. This study was originally posted on December 21st, 2018 and was last edited on October 21st, 2020. If you are looking for other trials, there are currently 1984 trials actively recruiting patients with lung cancer and 2439 trials for pembrolizumab that are looking for new participants."
Answered by AI
How many study participants will be included in this research?
"Enrollment for this study concluded on 10/21/2022, as reflected on the clinical trial's last edit date. If you are seeking other active trials, 1984 studies involving lung cancer and 2439 pembrolizumab studies are still recruiting patients."
Answered by AI
Has pembrolizumab been cleared by the FDA?
"Pembrolizumab's safety is based on both efficacy data from Phase 3 trials as well as numerous rounds of supportive safety data, so it received a score of 3."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger