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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
Must not have
Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1β inhibitor).
Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations (identified in exons 19, 20, or 21), and/or ALK rearrangement by locally approved laboratory testing.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 32 months
Awards & highlights
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My lung cancer is at an advanced stage but hasn't been treated yet.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously been treated with canakinumab or similar drugs.
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My cancer has specific changes in the EGFR gene or ALK rearrangement.
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I have brain metastases or lepto-meningeal disease that hasn't been treated.
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I have a weakened immune system or an infection.
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I have received immunotherapy targeting specific immune pathways before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 32 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 32 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
Part 1 (Safety Run-in): Number of Participants With Dose-limiting Toxicities (DLTs)
Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Survival (OS) Per Investigator Assessment Using RECIST v1.1
Part 2 (Double-blind, Randomized, Placebo-controlled): Progression-free Survival (PFS) Per Investigator Assessment Using RECIST v1.1
Secondary study objectives
All Collected Deaths
Part 1 (Safety Run-in): Antidrug Antibodies (ADA) of Canakinumab
Part 1 (Safety Run-in): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1
+13 more

Side effects data

From 2024 Phase 3 trial • 453 Patients • NCT03062358
36%
Aspartate aminotransferase increased
30%
Alanine aminotransferase increased
28%
Blood bilirubin increased
21%
Platelet count decreased
18%
Gamma-glutamyltransferase increased
17%
White blood cell count decreased
17%
Pyrexia
16%
Diarrhoea
15%
Anaemia
15%
Decreased appetite
15%
Rash
14%
Blood alkaline phosphatase increased
14%
Neutrophil count decreased
12%
Hypoalbuminaemia
12%
Pruritus
11%
Cough
11%
Upper respiratory tract infection
10%
Proteinuria
10%
Hypothyroidism
10%
Lymphocyte count decreased
9%
Constipation
9%
Arthralgia
8%
Weight decreased
7%
Abdominal pain
7%
Nausea
7%
Bilirubin conjugated increased
7%
Insomnia
6%
Asthenia
6%
Fatigue
6%
Hyperglycaemia
6%
Hypokalaemia
6%
Hyponatraemia
6%
Hypoproteinaemia
6%
Back pain
6%
Hypertension
6%
Vomiting
6%
Abdominal distension
5%
Blood lactate dehydrogenase increased
5%
Hyperthyroidism
5%
Ascites
5%
Abdominal pain upper
5%
Hepatitis B DNA increased
4%
Malaise
3%
Blood glucose increased
3%
Blood creatinine increased
2%
Upper gastrointestinal haemorrhage
2%
Pneumonia
2%
Dyspepsia
1%
Gastrointestinal haemorrhage
1%
Autoimmune hepatitis
1%
Hepatic failure
1%
Hepatitis E
1%
Influenza
1%
Sepsis
1%
Tumour haemorrhage
1%
Hepatic encephalopathy
1%
Pneumonitis
1%
Dysphonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab (First Course) + BSC
Placebo + BSC
Pembrolizumab Second Course

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part 2: Placebo+pembro+CTxExperimental Treatment7 Interventions
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Group II: Part 2: Canakinumab+pembro+CTxExperimental Treatment7 Interventions
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
Group III: Part 1: Cohort CExperimental Treatment4 Interventions
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.
Group IV: Part 1: Cohort BExperimental Treatment4 Interventions
Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.
Group V: Part 1: Cohort AExperimental Treatment4 Interventions
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.
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
~5890
canakinumab
2014
Completed Phase 3
~280
nab-paclitaxel
2008
Completed Phase 4
~1420
carboplatin
2010
Completed Phase 3
~4790
pemetrexed
2005
Completed Phase 3
~5000

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,921 Previous Clinical Trials
4,253,639 Total Patients Enrolled

Media Library

Cisplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03631199 — Phase 3
Lung Cancer Research Study Groups: Part 1: Cohort A, Part 1: Cohort B, Part 1: Cohort C, Part 2: Canakinumab+pembro+CTx, Part 2: Placebo+pembro+CTx
Lung Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03631199 — Phase 3
Cisplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03631199 — Phase 3
~96 spots leftby Dec 2025
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