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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03447769




Registration number
NCT03447769
Ethics application status
Date submitted
19/02/2018
Date registered
27/02/2018
Date last updated
3/03/2023

Titles & IDs
Public title
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
Scientific title
A Phase III, Multicenter, Randomized, Double Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Canakinumab Versus Placebo as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II -IIIA and IIIB (T>5cm N2) Completely Resected (R0) Non-small Cell Lung Cancer (NSCLC)
Secondary ID [1] 0 0
2017-004011-39
Secondary ID [2] 0 0
CACZ885T2301
Universal Trial Number (UTN)
Trial acronym
Canopy-A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Canakinumab
Treatment: Drugs - Placebo

Experimental: canakinumab - Participants will receive canakinumab for 18 cycles (approximately 54 weeks).

Placebo Comparator: Placebo - Participants will receive canakinumab placebo for 18 cycles (approximately 54 weeks).


Treatment: Drugs: Canakinumab
Canakinumab will be administered periodically for approximately 54 weeks.

Treatment: Drugs: Placebo
Placebo will be administered periodically for approximately 54 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease free survival (DFS) by local investigator
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
Disease free survival (DFS) by local investigator in PD-L1 subgroups
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
Disease free survival (DFS) by local investigator in CD8 subgroups
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [4] 0 0
Overall Survival (OS) by local investigator in PD-L1 subgroups
Timepoint [4] 0 0
up to approximately 5 years
Secondary outcome [5] 0 0
Overall Survival (OS) by local investigator in CD8 subgroups
Timepoint [5] 0 0
up to approximately 5 years
Secondary outcome [6] 0 0
Lung Cancer Specific Survival (LCSS)
Timepoint [6] 0 0
up to approximately 5 years
Secondary outcome [7] 0 0
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of canakinumab
Timepoint [7] 0 0
Up to approximately 5 years
Secondary outcome [8] 0 0
Maximum Observed Plasma Concentration (Cmax) of canakinumab
Timepoint [8] 0 0
Up to approximately 5 years
Secondary outcome [9] 0 0
Trough Concentration (Cmin) of canakinumab
Timepoint [9] 0 0
Up to approximately 5 years
Secondary outcome [10] 0 0
Anti-drug Antibody (ADA) prevalence at baseline
Timepoint [10] 0 0
Baseline
Secondary outcome [11] 0 0
Anti-drug Antibody (ADA) incidence
Timepoint [11] 0 0
Up to approximately 5 years
Secondary outcome [12] 0 0
Time to definitive 10 point deterioration symptom scores of pain,cough and dyspnea per EORTC QLQ-LC13 questionnaire
Timepoint [12] 0 0
Up to approximately 5 years
Secondary outcome [13] 0 0
Time to definitive 10 point deterioration of global health status/QoL, shortness of breath and pain per EORTC QLQ-C30 questionnaire
Timepoint [13] 0 0
Up to approximately 5 years
Secondary outcome [14] 0 0
Time to first 10 point deterioration for symptom scores of pain, cough and dyspnea per EORTC QLQ-LC13 questionnaire
Timepoint [14] 0 0
Up to approximately 5 years
Secondary outcome [15] 0 0
Time to first 10 point deterioration of global health status/QoL, shortness of breath and pain per EORTC QLQ-C30 questionnaire
Timepoint [15] 0 0
Up to approximately 5 years
Secondary outcome [16] 0 0
Utility scores of the EQ-5D-5L
Timepoint [16] 0 0
Up to approximately 5 years

Eligibility
Key inclusion criteria
- Have completely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA-IIIA and IIIB (N2 disease
only) OR have NSCLC Stage IIA-IIIA, IIIB (N2 disease only) and are candidates for
complete resection surgery

- Cisplatin-based chemotherapy is mandatory for all subjects (Exception: In subjects
with stage IIA disease with no nodal involvement, cisplatin-based chemotherapy can be
administered if recommended by the treating physician). When required, a minimum of
two cycles of cisplatin-based chemotherapy is mandatory, after which additional
therapies can be given based upon local clinical practice and/or guidelines.
Typically, chemotherapy is initiated within 60 days of surgery.

- Must have recovered from all toxicities related to prior systemic therapy to grade = 1
(CTCAE v 4.03). Exception to this criterion: subjects with any grade of alopecia and
grade 2 or less neuropathy are allowed to enter the study

- Have ECOG performance status (PS) of 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have unresectable or metastatic disease, positive microscopic margins on the pathology
report, and/or gross disease remaining at the time of surgery

- Have received any neoadjuvant therapy

- Presence or history of a malignant disease, other than the resected NSCLC, that has
been diagnosed and/or required therapy within the past 3 years Exceptions to this
exclusion include the following: completely resected basal cell and squamous cell skin
cancers, completely resected carcinoma in situ of any type and hormonal maintenance
for breast and prostate cancer > 3 years.

- Have a history of current diagnosis of cardiac disease

- Have uncontrolled diabetes

- Have known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C
(positive or indeterminate central laboratory results)

- Subjects must be evaluated for tuberculosis as per local treatment guidelines or
clinical practice. Subjects with active tuberculosis are not eligible.

- Have suspected or proven immunocompromised state as described in the protocol

- Had Live and attenuated vaccination within 3 months prior to first dose of study drug
(e.g. MMR, Yellow Fever, Rotavirus, Smallpox, etc.).

Other inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/02/2023
Sample size
Target
Accrual to date
Final
1382
Recruitment in Australia
Recruitment state(s)
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Country [213] 0 0
United Kingdom
State/province [213] 0 0
Gloucestershire
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Merseyside
Country [215] 0 0
United Kingdom
State/province [215] 0 0
Suffolk
Country [216] 0 0
United Kingdom
State/province [216] 0 0
Surrey
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Birmingham
Country [218] 0 0
United Kingdom
State/province [218] 0 0
Bristol
Country [219] 0 0
United Kingdom
State/province [219] 0 0
Leicester
Country [220] 0 0
United Kingdom
State/province [220] 0 0
London
Country [221] 0 0
United Kingdom
State/province [221] 0 0
Nottingham
Country [222] 0 0
United Kingdom
State/province [222] 0 0
Oxford
Country [223] 0 0
United Kingdom
State/province [223] 0 0
Preston
Country [224] 0 0
United Kingdom
State/province [224] 0 0
Stoke-on-Trent
Country [225] 0 0
Vietnam
State/province [225] 0 0
Hanoi

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of the study is to compare the efficacy and safety of canakinumab versus
placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II -IIIA and the
subset of IIIB (T>5cm N2 disease) completely resected (R0) non-small cell lung cancer
(NSCLC).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03447769
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03447769