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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
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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)
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Secondary ID [1]
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2017-004011-39
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Secondary ID [2]
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CACZ885T2301
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Universal Trial Number (UTN)
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Trial acronym
Canopy-A
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disease free survival (DFS) by local investigator
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Assessment method [1]
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DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause.
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Timepoint [1]
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Up to approximately 5 years
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause.
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Timepoint [1]
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Up to approximately 5 years
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Secondary outcome [2]
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Disease free survival (DFS) by local investigator in PD-L1 subgroups
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Assessment method [2]
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DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause.
DFS analysis will be performed by programmed cell death-ligand 1 (PD-L1) status (positive, negative) where a positive status is defined as having = 1% expression and a negative status is defined as having < 1% expression.
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Timepoint [2]
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0
Up to approximately 5 years
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Secondary outcome [3]
0
0
Disease free survival (DFS) by local investigator in CD8 subgroups
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Assessment method [3]
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DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause.
DFS analysis will be performed by CD8 subgroups with the median and quartiles of baseline CD8 expression as cut-offs.
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Timepoint [3]
0
0
Up to approximately 5 years
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Secondary outcome [4]
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Overall Survival (OS) by local investigator in PD-L1 subgroups
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Assessment method [4]
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Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. OS analysis will be performed by programmed cell death-ligand 1 (PD-L1) status (positive, negative) where a positive status is defined as having = 1% expression and a negative status is defined as having < 1% expression.
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Timepoint [4]
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0
up to approximately 5 years
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Secondary outcome [5]
0
0
Overall Survival (OS) by local investigator in CD8 subgroups
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Assessment method [5]
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Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. OS analysis will be performed by CD8 subgroups with the median and quartiles of baseline CD8 expression as cut-offs.
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Timepoint [5]
0
0
up to approximately 5 years
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Secondary outcome [6]
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Lung Cancer Specific Survival (LCSS)
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Assessment method [6]
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LCSS is defined as the time from date of randomization to the date of death due to lung cancer.
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Timepoint [6]
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0
up to approximately 5 years
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Secondary outcome [7]
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Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of canakinumab
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Assessment method [7]
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To characterize the pharmacokinetics of canakinumab therapy. AUClast will be calculated from serum concentration-time data.
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Timepoint [7]
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Up to approximately 5 years
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Secondary outcome [8]
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Maximum Observed Plasma Concentration (Cmax) of canakinumab
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Assessment method [8]
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To characterize the pharmacokinetics of canakinumab therapy. Cmax will be calculated from serum concentration-time data.
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Timepoint [8]
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Up to approximately 5 years
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Secondary outcome [9]
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Trough Concentration (Cmin) of canakinumab
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Assessment method [9]
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To characterize the pharmacokinetics of canakinumab therapy. Cmin will be calculated from serum concentration-time data.
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Timepoint [9]
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Up to approximately 5 years
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Secondary outcome [10]
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Anti-drug Antibody (ADA) prevalence at baseline
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Assessment method [10]
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Immunogenicity to canakinumab prior to canakinumab exposure. ADA prevalence at baseline wil be calculated as the proportion of participants who had an ADA positive result at baseline
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Timepoint [10]
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Baseline
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Secondary outcome [11]
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Anti-drug Antibody (ADA) incidence
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Assessment method [11]
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ADA incidence on treatment will be calculated as the proportion of participants who were treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)
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Timepoint [11]
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0
Up to approximately 5 years
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Secondary outcome [12]
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Time to definitive 10 point deterioration symptom scores of pain,cough and dyspnea per EORTC QLQ-LC13 questionnaire
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Assessment method [12]
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The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) is used in conjunction with the EORTC QLQ-C30 and provides information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporates one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores range from 0 to 100. A high score indicates a high level of symptoms.
The time to definitive 10 point deterioration symptom scores of pain, cough and dyspnea is defined as the time from the date of randomization to the date of event, which is defined as at least 10 points relative to baseline worsening of the EORTC QLQ-LC13 symptom score with no later change below this thereshold or death due to any cause, whichever occurs earlier
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Timepoint [12]
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0
Up to approximately 5 years
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Secondary outcome [13]
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Time to definitive 10 point deterioration of global health status/QoL, shortness of breath and pain per EORTC QLQ-C30 questionnaire
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Assessment method [13]
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The EORTC QLQ-C30 is a questionnaire developed to assess the health-related quality of life of cancer participants. It assesses 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/quality of life (QoL) scale. All of the domain scores range from 0 to 100. A high score for a functional scale indicates a high and healthy level of functioning but a high score for a symptom scale indicates a high level of symptoms.
The time to definitive 10 point deterioration of global health status/QoL, shortness of breath and pain is defined as the time from the date of randomization to the date of event, which is defined as at least 10 points relative to baseline worsening of the EORTC QLQ-C30 score with no later change below this threshold or death due to any cause, whichever occurs earlier.
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Timepoint [13]
0
0
Up to approximately 5 years
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Secondary outcome [14]
0
0
Time to first 10 point deterioration for symptom scores of pain, cough and dyspnea per EORTC QLQ-LC13 questionnaire
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Assessment method [14]
0
0
The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) is used in conjunction with the EORTC QLQ-C30 and provides information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporates one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores range from 0 to 100. A high score indicates a high level of symptoms.
The time to first 10 point deterioration symptom scores of pain, cough and dyspnea is defined as the time from the date of randomization to the first onset of at least 10 points absolute increase from baseline (worsening) in symptoms scores or death due to any cause, whichever occurs earlier.
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Timepoint [14]
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0
Up to approximately 5 years
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Secondary outcome [15]
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Time to first 10 point deterioration of global health status/QoL, shortness of breath and pain per EORTC QLQ-C30 questionnaire
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Assessment method [15]
0
0
The EORTC QLQ-C30 is a questionnaire developed to assess the health-related quality of life of cancer participants. It assesses 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/quality of life (QoL) scale. All of the domain scores range from 0 to 100. A high score for a functional scale indicates a high and healthy level of functioning but a high score for a symptom scale indicates a high level of symptoms.
The time to first 10 point deterioration of global health status/QoL, shortness of breath and pain scores is defined as the time from the date of randomization to the first onset of at least 10 points absolute increase from baseline (worsening) in symptoms scores or death due to any cause, whichever occurs earlier.
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Timepoint [15]
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Up to approximately 5 years
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Secondary outcome [16]
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Utility scores of the EQ-5D-5L
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Assessment method [16]
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EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions.
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Timepoint [16]
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Up to approximately 5 years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/03/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/02/2023
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Sample size
Target
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Accrual to date
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Final
1382
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Arkansas
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California
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Colorado
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Florida
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Illinois
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Kansas
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Nebraska
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Ohio
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Oregon
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United States of America
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Tennessee
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Texas
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Sante Fe
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Argentina
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Cordoba
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Austria
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Graz
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Austria
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Klagenfurt
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Austria
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Krems
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Austria
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Vienna
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Piaui
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Brazil
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PR
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Brazil
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SP
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Bulgaria
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Sofia
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Chile
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Anhui
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Guangong
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Guizhou
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Henan
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Jiangsu
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Jilin
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Liaoning
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Tianjin
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Colombia
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Bogota
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Ostrava Vitkovice
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Bron
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Suresnes
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Toulouse
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Georgia
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Batumi
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Georgia
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Tbilisi
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Germany
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Baden-Württemberg
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Germany
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Bayern
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Aachen
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Koeln
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Germany
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Germany
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Germany
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Germany
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Germany
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Italy
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Italy
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Italy
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Italy
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Italy
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RA
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Italy
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TO
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Tokyo
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Japan
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Busan
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Seoul
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Bergen
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Drammen
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Norway
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Portugal
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Matosinhos
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Portugal
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Porto
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Kaliningrad
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Russian Federation
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Russian Federation
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Omsk
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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St Petersburg
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Russian Federation
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Spain
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Madrid
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Bern
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Fribourg
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Thailand
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THA
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Thailand
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Bangkok
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Turkey
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Adana
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Pendik / Istanbul
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United Kingdom
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United Kingdom
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Cornwall
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Gloucestershire
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United Kingdom
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United Kingdom
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Surrey
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United Kingdom
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Birmingham
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United Kingdom
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Bristol
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Nottingham
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United Kingdom
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Oxford
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United Kingdom
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Preston
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United Kingdom
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Stoke-on-Trent
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Vietnam
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Hanoi
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03447769
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Trial related presentations / publications
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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
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03447769
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