Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03447769
Ethics application status
Date submitted
19/02/2018
Date registered
27/02/2018

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

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


Treatment: Drugs: Canakinumab
200 mg of canakinumab administered subcutaneously on day 1 of every 21-day cycle for 18 cycles. Canakinumab solution for injection was provided by Novartis as ready-to-use pre-filled syringes to be administered by study personnel.

Treatment: Drugs: Placebo
Placebo administered subcutaneously on day 1 of every 21-day cycle for 18 cycles. Placebo solution for injection was provided by Novartis as ready-to-use pre-filled syringes to be administered by study personnel.
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 4 years
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 4.3 years
Secondary outcome [2] 0 0
Overall Survival (OS) in PD-L1 Subgroups
Timepoint [2] 0 0
Up to approximately 4.3 years
Secondary outcome [3] 0 0
Overall Survival (OS) in CD8 Subgroups
Timepoint [3] 0 0
up to approximately 4.3 years
Secondary outcome [4] 0 0
Lung Cancer Specific Survival (LCSS)
Timepoint [4] 0 0
Up to approximately 4.3 years
Secondary outcome [5] 0 0
Disease Free Survival (DFS) by Local Investigator in PD-L1 Subgroups
Timepoint [5] 0 0
Up to approximately 4 years
Secondary outcome [6] 0 0
Disease Free Survival (DFS) by Local Investigator in CD8 Subgroups
Timepoint [6] 0 0
Up to approximately 4 years
Secondary outcome [7] 0 0
Canakinumab Serum Concentrations
Timepoint [7] 0 0
Cycle 1 on day 1 (pre-dose), day 8 and 15; Cycle 2, 4, 6, 9 and 12 on day 1 (pre-dose). Cycle=21 days
Secondary outcome [8] 0 0
Canakinumab Anti-drug Antibody (ADA) Prevalence at Baseline
Timepoint [8] 0 0
Baseline
Secondary outcome [9] 0 0
Canakinumab ADA Incidence
Timepoint [9] 0 0
From baseline up to 130 days after end of treatment, assessed up to approx. 1.5 years
Secondary outcome [10] 0 0
Time to Definitive 10 Point Deterioration Symptom Scores of Pain,Cough and Dyspnea Per European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)- Lung Cancer (LC) 13 Questionnaire
Timepoint [10] 0 0
From baseline up to approximately 4 years
Secondary outcome [11] 0 0
Time to Definitive 10 Point Deterioration of Global Health Status/Quality of Life (QoL), Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire
Timepoint [11] 0 0
From baseline up to approximately 4 years
Secondary outcome [12] 0 0
Time to First 10 Point Deterioration for Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire
Timepoint [12] 0 0
From baseline up to approximately 4 years
Secondary outcome [13] 0 0
Time to First 10 Point Deterioration of Global Health Status/QoL, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire
Timepoint [13] 0 0
From baseline up to approximately 4 years
Secondary outcome [14] 0 0
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L)
Timepoint [14] 0 0
Baseline, every 3 weeks for 14 months; end of treatment; every 4 weeks up to 130 days post-treatment; at 18,24,30,36 and 48 months post-randomization (if no recurrence); 7 and 28 days post-disease progression, up to approx. 4 years.

Eligibility
Key inclusion criteria
Key

* Had completely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA-IIIA and IIIB (N2 disease only) OR had NSCLC Stage IIA-IIIA, IIIB (N2 disease only) and were candidates for complete resection surgery.
* Cisplatin-based chemotherapy was mandatory for all subjects (Exception: In subjects with stage IIA disease with no nodal involvement, cisplatin-based chemotherapy could be administered if recommended by the treating physician). When required, a minimum of two cycles of cisplatin-based chemotherapy was mandatory, after which additional therapies could be given based upon local clinical practice and/or guidelines. Typically, chemotherapy was initiated within 60 days of surgery.
* Radiation therapy was allowed if indicated as per local guidelines or practice.
* Had recovered from all toxicities related to prior systemic therapy to grade = 1 (CTCAE v 5.0). Exception to this criterion: subjects with any grade of alopecia and grade 2 or less neuropathy were allowed to enter the study
* Had ECOG performance status (PS) of 0 or 1

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Had unresectable or metastatic disease, positive microscopic margins on the pathology report, and/or gross disease remaining at the time of surgery
* Had received any neoadjuvant therapy
* Had presence or history of a malignant disease, other than the resected NSCLC, that had been diagnosed and/or required therapy within the past 3 years Exceptions to this exclusion included 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.
* Had a history of current diagnosis of cardiac disease
* Had uncontrolled diabetes
* Had known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results)
* Subjects had to be evaluated for tuberculosis as per local treatment guidelines or clinical practice. Subjects with active tuberculosis were not eligible.
* Had 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.).

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
Stopped early
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)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
Argentina
State/province [13] 0 0
Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Santa Fe
Country [15] 0 0
Argentina
State/province [15] 0 0
Sante Fe
Country [16] 0 0
Argentina
State/province [16] 0 0
Cordoba
Country [17] 0 0
Austria
State/province [17] 0 0
Graz
Country [18] 0 0
Austria
State/province [18] 0 0
Klagenfurt
Country [19] 0 0
Austria
State/province [19] 0 0
Krems
Country [20] 0 0
Austria
State/province [20] 0 0
Vienna
Country [21] 0 0
Brazil
State/province [21] 0 0
Piaui
Country [22] 0 0
Brazil
State/province [22] 0 0
PR
Country [23] 0 0
Brazil
State/province [23] 0 0
SP
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Sofia
Country [25] 0 0
Canada
State/province [25] 0 0
Alberta
Country [26] 0 0
Canada
State/province [26] 0 0
New Brunswick
Country [27] 0 0
Canada
State/province [27] 0 0
Nova Scotia
Country [28] 0 0
Canada
State/province [28] 0 0
Quebec
Country [29] 0 0
Chile
State/province [29] 0 0
Santiago
Country [30] 0 0
China
State/province [30] 0 0
Anhui
Country [31] 0 0
China
State/province [31] 0 0
Beijing
Country [32] 0 0
China
State/province [32] 0 0
Chongqing
Country [33] 0 0
China
State/province [33] 0 0
Guangdong
Country [34] 0 0
China
State/province [34] 0 0
Guangong
Country [35] 0 0
China
State/province [35] 0 0
Guizhou
Country [36] 0 0
China
State/province [36] 0 0
Henan
Country [37] 0 0
China
State/province [37] 0 0
Jiangsu
Country [38] 0 0
China
State/province [38] 0 0
Jilin
Country [39] 0 0
China
State/province [39] 0 0
Liaoning
Country [40] 0 0
China
State/province [40] 0 0
Shandong
Country [41] 0 0
China
State/province [41] 0 0
Shanghai
Country [42] 0 0
China
State/province [42] 0 0
Shanxi
Country [43] 0 0
China
State/province [43] 0 0
Shengyang
Country [44] 0 0
China
State/province [44] 0 0
Sichuan
Country [45] 0 0
China
State/province [45] 0 0
Zhejiang
Country [46] 0 0
China
State/province [46] 0 0
Changsha
Country [47] 0 0
China
State/province [47] 0 0
Chengdu
Country [48] 0 0
China
State/province [48] 0 0
Fujian
Country [49] 0 0
China
State/province [49] 0 0
Tianjin
Country [50] 0 0
Colombia
State/province [50] 0 0
Bogota
Country [51] 0 0
Czechia
State/province [51] 0 0
Ostrava Vitkovice
Country [52] 0 0
Czechia
State/province [52] 0 0
Prague 2
Country [53] 0 0
France
State/province [53] 0 0
Bouches Du Rhone
Country [54] 0 0
France
State/province [54] 0 0
Cedex 09
Country [55] 0 0
France
State/province [55] 0 0
Herault
Country [56] 0 0
France
State/province [56] 0 0
Amiens
Country [57] 0 0
France
State/province [57] 0 0
Angers Cedex 9
Country [58] 0 0
France
State/province [58] 0 0
Avignon Cedex
Country [59] 0 0
France
State/province [59] 0 0
Bayonne
Country [60] 0 0
France
State/province [60] 0 0
Brest
Country [61] 0 0
France
State/province [61] 0 0
Bron
Country [62] 0 0
France
State/province [62] 0 0
Clermont-Ferrand
Country [63] 0 0
France
State/province [63] 0 0
Creteil
Country [64] 0 0
France
State/province [64] 0 0
La Rochelle
Country [65] 0 0
France
State/province [65] 0 0
La Seyne sur mer
Country [66] 0 0
France
State/province [66] 0 0
Lille
Country [67] 0 0
France
State/province [67] 0 0
Paris
Country [68] 0 0
France
State/province [68] 0 0
Pessac Cedex
Country [69] 0 0
France
State/province [69] 0 0
Poitiers
Country [70] 0 0
France
State/province [70] 0 0
Saint-Herblain Cédex
Country [71] 0 0
France
State/province [71] 0 0
Strasbourg Cedex
Country [72] 0 0
France
State/province [72] 0 0
Suresnes
Country [73] 0 0
France
State/province [73] 0 0
Toulouse
Country [74] 0 0
Georgia
State/province [74] 0 0
Batumi
Country [75] 0 0
Georgia
State/province [75] 0 0
Tbilisi
Country [76] 0 0
Germany
State/province [76] 0 0
Baden-Württemberg
Country [77] 0 0
Germany
State/province [77] 0 0
Bayern
Country [78] 0 0
Germany
State/province [78] 0 0
Nordrhein Westfalen
Country [79] 0 0
Germany
State/province [79] 0 0
North Rhine-Westphalia
Country [80] 0 0
Germany
State/province [80] 0 0
Aachen
Country [81] 0 0
Germany
State/province [81] 0 0
Berlin
Country [82] 0 0
Germany
State/province [82] 0 0
Chemnitz
Country [83] 0 0
Germany
State/province [83] 0 0
Dresden
Country [84] 0 0
Germany
State/province [84] 0 0
Erfurt
Country [85] 0 0
Germany
State/province [85] 0 0
Essen
Country [86] 0 0
Germany
State/province [86] 0 0
Georgsmarienhuette
Country [87] 0 0
Germany
State/province [87] 0 0
Gera
Country [88] 0 0
Germany
State/province [88] 0 0
Gerlingen
Country [89] 0 0
Germany
State/province [89] 0 0
Grosshansdorf
Country [90] 0 0
Germany
State/province [90] 0 0
Halle (Saale)
Country [91] 0 0
Germany
State/province [91] 0 0
Koeln
Country [92] 0 0
Germany
State/province [92] 0 0
Leipzig
Country [93] 0 0
Germany
State/province [93] 0 0
Minden
Country [94] 0 0
Germany
State/province [94] 0 0
Muenchen
Country [95] 0 0
Germany
State/province [95] 0 0
Nuernberg
Country [96] 0 0
Germany
State/province [96] 0 0
Solingen
Country [97] 0 0
Germany
State/province [97] 0 0
Ulm
Country [98] 0 0
Germany
State/province [98] 0 0
Wuerzburg
Country [99] 0 0
Greece
State/province [99] 0 0
Attica
Country [100] 0 0
Greece
State/province [100] 0 0
GR
Country [101] 0 0
Greece
State/province [101] 0 0
Athens
Country [102] 0 0
Greece
State/province [102] 0 0
Thessaloniki
Country [103] 0 0
Hong Kong
State/province [103] 0 0
Hong Kong
Country [104] 0 0
Hong Kong
State/province [104] 0 0
Kowloon
Country [105] 0 0
Hong Kong
State/province [105] 0 0
Tuen Mun
Country [106] 0 0
Hungary
State/province [106] 0 0
Pest
Country [107] 0 0
Hungary
State/province [107] 0 0
Veszprem
Country [108] 0 0
Iceland
State/province [108] 0 0
Reykjavik
Country [109] 0 0
India
State/province [109] 0 0
Maharashtra
Country [110] 0 0
India
State/province [110] 0 0
West Bengal
Country [111] 0 0
India
State/province [111] 0 0
Delhi
Country [112] 0 0
Israel
State/province [112] 0 0
Haifa
Country [113] 0 0
Israel
State/province [113] 0 0
Holon
Country [114] 0 0
Italy
State/province [114] 0 0
AN
Country [115] 0 0
Italy
State/province [115] 0 0
BA
Country [116] 0 0
Italy
State/province [116] 0 0
FC
Country [117] 0 0
Italy
State/province [117] 0 0
MB
Country [118] 0 0
Italy
State/province [118] 0 0
MI
Country [119] 0 0
Italy
State/province [119] 0 0
PD
Country [120] 0 0
Italy
State/province [120] 0 0
PG
Country [121] 0 0
Italy
State/province [121] 0 0
PN
Country [122] 0 0
Italy
State/province [122] 0 0
RA
Country [123] 0 0
Italy
State/province [123] 0 0
RM
Country [124] 0 0
Italy
State/province [124] 0 0
TO
Country [125] 0 0
Japan
State/province [125] 0 0
Aichi
Country [126] 0 0
Japan
State/province [126] 0 0
Aomori
Country [127] 0 0
Japan
State/province [127] 0 0
Ehime
Country [128] 0 0
Japan
State/province [128] 0 0
Fukuoka
Country [129] 0 0
Japan
State/province [129] 0 0
Hokkaido
Country [130] 0 0
Japan
State/province [130] 0 0
Hyogo
Country [131] 0 0
Japan
State/province [131] 0 0
Ishikawa
Country [132] 0 0
Japan
State/province [132] 0 0
Iwate
Country [133] 0 0
Japan
State/province [133] 0 0
Kanagawa
Country [134] 0 0
Japan
State/province [134] 0 0
Miyagi
Country [135] 0 0
Japan
State/province [135] 0 0
Osaka
Country [136] 0 0
Japan
State/province [136] 0 0
Saitama
Country [137] 0 0
Japan
State/province [137] 0 0
Shizuoka
Country [138] 0 0
Japan
State/province [138] 0 0
Tokyo
Country [139] 0 0
Japan
State/province [139] 0 0
Yamaguchi
Country [140] 0 0
Japan
State/province [140] 0 0
Wakayama
Country [141] 0 0
Jordan
State/province [141] 0 0
Amman
Country [142] 0 0
Korea, Republic of
State/province [142] 0 0
Chungcheongbuk Do
Country [143] 0 0
Korea, Republic of
State/province [143] 0 0
Korea
Country [144] 0 0
Korea, Republic of
State/province [144] 0 0
Busan
Country [145] 0 0
Korea, Republic of
State/province [145] 0 0
Seoul
Country [146] 0 0
Lebanon
State/province [146] 0 0
Ashrafieh
Country [147] 0 0
Lebanon
State/province [147] 0 0
Beirut
Country [148] 0 0
Lebanon
State/province [148] 0 0
Saida
Country [149] 0 0
Lebanon
State/province [149] 0 0
Tripoli
Country [150] 0 0
Malaysia
State/province [150] 0 0
Sarawak
Country [151] 0 0
Malaysia
State/province [151] 0 0
Kuala Lumpur
Country [152] 0 0
Malaysia
State/province [152] 0 0
Pulau Pinang
Country [153] 0 0
Norway
State/province [153] 0 0
Bergen
Country [154] 0 0
Norway
State/province [154] 0 0
Drammen
Country [155] 0 0
Norway
State/province [155] 0 0
Oslo
Country [156] 0 0
Norway
State/province [156] 0 0
Tromso
Country [157] 0 0
Panama
State/province [157] 0 0
Panama City
Country [158] 0 0
Peru
State/province [158] 0 0
Lima
Country [159] 0 0
Philippines
State/province [159] 0 0
Makati City
Country [160] 0 0
Poland
State/province [160] 0 0
Ma3opolska
Country [161] 0 0
Poland
State/province [161] 0 0
Konin
Country [162] 0 0
Poland
State/province [162] 0 0
Olsztyn
Country [163] 0 0
Poland
State/province [163] 0 0
Poznan
Country [164] 0 0
Poland
State/province [164] 0 0
Rzeszow
Country [165] 0 0
Poland
State/province [165] 0 0
Warszawa
Country [166] 0 0
Portugal
State/province [166] 0 0
Lisboa
Country [167] 0 0
Portugal
State/province [167] 0 0
Matosinhos
Country [168] 0 0
Portugal
State/province [168] 0 0
Porto
Country [169] 0 0
Romania
State/province [169] 0 0
Cluj
Country [170] 0 0
Romania
State/province [170] 0 0
Bucuresti
Country [171] 0 0
Romania
State/province [171] 0 0
Cluj-Napoca
Country [172] 0 0
Romania
State/province [172] 0 0
Iasi
Country [173] 0 0
Russian Federation
State/province [173] 0 0
Arkhangelsk
Country [174] 0 0
Russian Federation
State/province [174] 0 0
Kaliningrad
Country [175] 0 0
Russian Federation
State/province [175] 0 0
Moscow Region Istra Village
Country [176] 0 0
Russian Federation
State/province [176] 0 0
Obninsk
Country [177] 0 0
Russian Federation
State/province [177] 0 0
Omsk
Country [178] 0 0
Russian Federation
State/province [178] 0 0
Pushkin Saint Petersburg
Country [179] 0 0
Russian Federation
State/province [179] 0 0
Ryazan
Country [180] 0 0
Russian Federation
State/province [180] 0 0
Saint Petersburg
Country [181] 0 0
Russian Federation
State/province [181] 0 0
St Petersburg
Country [182] 0 0
Russian Federation
State/province [182] 0 0
Yaroslavl
Country [183] 0 0
Slovenia
State/province [183] 0 0
Ljubljana
Country [184] 0 0
Spain
State/province [184] 0 0
Andalucia
Country [185] 0 0
Spain
State/province [185] 0 0
Cantabria
Country [186] 0 0
Spain
State/province [186] 0 0
Catalunya
Country [187] 0 0
Spain
State/province [187] 0 0
Comunidad Valenciana
Country [188] 0 0
Spain
State/province [188] 0 0
Galicia
Country [189] 0 0
Spain
State/province [189] 0 0
Santa Cruz De Tenerife
Country [190] 0 0
Spain
State/province [190] 0 0
Madrid
Country [191] 0 0
Switzerland
State/province [191] 0 0
Bern
Country [192] 0 0
Switzerland
State/province [192] 0 0
Fribourg
Country [193] 0 0
Switzerland
State/province [193] 0 0
Geneve 14
Country [194] 0 0
Taiwan
State/province [194] 0 0
Taiwan ROC
Country [195] 0 0
Taiwan
State/province [195] 0 0
Changhua
Country [196] 0 0
Taiwan
State/province [196] 0 0
Hualien
Country [197] 0 0
Taiwan
State/province [197] 0 0
Kaohsiung
Country [198] 0 0
Taiwan
State/province [198] 0 0
Taichung
Country [199] 0 0
Taiwan
State/province [199] 0 0
Taipei
Country [200] 0 0
Taiwan
State/province [200] 0 0
Taoyuan
Country [201] 0 0
Thailand
State/province [201] 0 0
Hat Yai
Country [202] 0 0
Thailand
State/province [202] 0 0
THA
Country [203] 0 0
Thailand
State/province [203] 0 0
Bangkok
Country [204] 0 0
Thailand
State/province [204] 0 0
Chaingmai
Country [205] 0 0
Turkey
State/province [205] 0 0
Yenimahalle
Country [206] 0 0
Turkey
State/province [206] 0 0
Adana
Country [207] 0 0
Turkey
State/province [207] 0 0
Istanbul
Country [208] 0 0
Turkey
State/province [208] 0 0
Izmir
Country [209] 0 0
Turkey
State/province [209] 0 0
Pendik Istanbul
Country [210] 0 0
United Kingdom
State/province [210] 0 0
Cambrigdeshire
Country [211] 0 0
United Kingdom
State/province [211] 0 0
Cornwall
Country [212] 0 0
United Kingdom
State/province [212] 0 0
Gloucestershire
Country [213] 0 0
United Kingdom
State/province [213] 0 0
Merseyside
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Suffolk
Country [215] 0 0
United Kingdom
State/province [215] 0 0
Surrey
Country [216] 0 0
United Kingdom
State/province [216] 0 0
Birmingham
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Bristol
Country [218] 0 0
United Kingdom
State/province [218] 0 0
Leicester
Country [219] 0 0
United Kingdom
State/province [219] 0 0
London
Country [220] 0 0
United Kingdom
State/province [220] 0 0
Nottingham
Country [221] 0 0
United Kingdom
State/province [221] 0 0
Oxford
Country [222] 0 0
United Kingdom
State/province [222] 0 0
Preston
Country [223] 0 0
United Kingdom
State/province [223] 0 0
Stoke-on-Trent
Country [224] 0 0
Vietnam
State/province [224] 0 0
Hanoi

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data will be available according to the process described on www.clinicalstudydatarequest.com.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03447769