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Canakinumab for Non-Small Cell Lung Cancer (Canopy-A 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 4.3 years

Awards & highlights

Canopy-A Trial Summary

This trial will compare canakinumab to placebo as an addition to standard therapy for stage II-III NSCLC.

Eligible Conditions

Non-Small Cell Lung Cancer

Canopy-A Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 4.3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 4.3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4.3 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

Disease Free Survival (DFS) by Local Investigator

Secondary outcome measures

Canakinumab ADA Incidence

Canakinumab Anti-drug Antibody (ADA) Prevalence at Baseline

Canakinumab Serum Concentrations

+11 more

Side effects data

From 2017 Phase 3 trial • 203 Patients • NCT02059291

50%

Bronchitis

50%

Diarrhoea

50%

Conjunctivitis

50%

Gastroenteritis

50%

Drug eruption

25%

Pyoderma gangrenosum

25%

Teething

25%

Pyogenic granuloma

25%

Dental caries

25%

Eye allergy

25%

Gastritis

25%

Nausea

25%

Vomiting

25%

Nasopharyngitis

25%

Malaise

25%

Aspartate aminotransferase increased

25%

Tonsillitis bacterial

25%

Alanine aminotransferase increased

25%

Neutrophil count increased

25%

Pain in extremity

25%

Headache

25%

Dermatitis allergic

25%

Rash pruritic

25%

Scleritis

25%

Hyper IgD syndrome

25%

Eye pain

25%

Familial mediterranean fever

25%

Constipation

25%

Stomatitis

25%

Influenza

25%

Rhinitis

25%

Sialoadenitis

25%

Viral upper respiratory tract infection

25%

C-reactive protein increased

25%

Neutrophil count decreased

25%

Serum amyloid A protein increased

25%

White blood cell count increased

25%

Hypocalcaemia

25%

Arthralgia

25%

Back pain

25%

Somnolence

25%

Eczema

25%

Keloid scar

25%

Urticaria

25%

Aphthous ulcer

25%

Ear infection

25%

Hypophosphataemia

25%

Pancytopenia

25%

Hepatic failure

25%

Laryngitis

25%

Haemorrhoids

25%

Pyrexia

25%

Viral tonsillitis

25%

Dehydration

25%

Pain of skin

25%

Skin ulcer

100%

80%

60%

40%

20%

Study treatment Arm

Non-randomized Open Label crFMF, HIDS/MKD Patients

Randomized ACZ and Placebo TRAPS Patients - ACZ Events

Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events

Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events

Randomized ACZ and Placebo crFMF Patients - ACZ Events

Any ACZ crFMF Patients - ACZ Events

Randomized ACZ and Placebo crFMF Pts - No Medication Events

Non-randomized Open Label TRAPS Patients

Any ACZ crFMF Patients - Placebo Events

Randomized ACZ and Placebo TRAPS Patients - Placebo Events

Randomized ACZ and Placebo TRAPS Pts - No Medication Events

Any ACZ HIDS/MKD Patients - No Medication Events

Any ACZ HIDS/MKD Patients - ACZ Events

Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events

Any ACZ TRAPS Patients - Placebo Events

Any ACZ TRAPS Patients - ACZ Events

Randomized ACZ and Placebo crFMF Patients - Placebo Events

Any ACZ TRAPS Patients - no Medication Events

Any ACZ HIDS/MKD Patients - Placebo Events

Any ACZ crFMF Patients - No Medication Events

Canopy-A Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: canakinumabExperimental Treatment1 Intervention

Participants received 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)

Group II: PlaceboPlacebo Group1 Intervention

Participants received canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Canakinumab

2011

Completed Phase 3

~3090

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,196,005 Total Patients Enrolled

Frequently Asked Questions

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

What are the primary purpose and conditions that Canakinumab is used to treat?

"Canakinumab can be used to manage muckle-wells syndrome (MWS), active systemic juvenile idiopathic arthritis, and neonatal-onset multisystem inflammatory disease (NOMID)."

Answered by AI

What has been shown about Canakinumab's safety in medical trials?

"Canakinumab has undergone Phase 3 trials, so there is some data supporting its efficacy and multiple rounds of data supporting safety. Our team at Power estimates that it is safe to use."

Answered by AI

Are there other examples of Canakinumab being used in a clinical trial?

"The first trial for canakinumab was completed in 2015 at San Francisco General Hospital. To date, there have been a total of 18315 completed trials worldwide. There are 16 active studies currently being conducted, with a notable concentration in Chattanooga, Tennessee."

Answered by AI

What are the key objectives of this research?

"The pharmaceutical sponsor for this trial, Novartis Pharmaceuticals, has reported that the primary objective of this study is to measure disease-free survival (DFS) over a period of up to 5 years. In addition to the primary outcome, this trial will also be evaluating secondary outcomes including time to first 10 point deterioration in global health status/quality of life (QoL), shortness of breath and pain scores on the EORTC QLQ-C30 questionnaire. The EORTC QLQ-C30 is a questionnaire developed to assess the health-related quality of life of cancer participants. It assess"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A

2018. "Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03447769.