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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03631199




Registration number
NCT03631199
Ethics application status
Date submitted
6/08/2018
Date registered
15/08/2018

Titles & IDs
Public title
Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects
Scientific title
A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)
Secondary ID [1] 0 0
2018-001547-32
Secondary ID [2] 0 0
CACZ885U2301
Universal Trial Number (UTN)
Trial acronym
CANOPY-1
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 - canakinumab-matching placebo
Treatment: Drugs - pembrolizumab
Treatment: Drugs - carboplatin
Treatment: Drugs - cisplatin
Treatment: Drugs - paclitaxel
Treatment: Drugs - nab-paclitaxel
Treatment: Drugs - pemetrexed

Experimental: Part 1: Cohort A - Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.

Experimental: Part 1: Cohort B - Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.

Experimental: Part 1: Cohort C - Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.

Experimental: Part 2: Canakinumab+pembro+CTx - Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.

Other: Part 2: Placebo+pembro+CTx - Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.


Treatment: Drugs: canakinumab
canakinumab 200 mg subcutaneous (s.c.) injection every 3 weeks (squamous and non-squamous)

Treatment: Drugs: canakinumab-matching placebo
canakinumab placebo every 3 weeks (squamous and non-squamous)

Treatment: Drugs: pembrolizumab
200 mg every 3 weeks (squamous and non-squamous)

Treatment: Drugs: carboplatin
Area Under the Curve (AUC) 5 mg/mL\*min every 3 weeks (non-squamous) or AUC 6 mg/mL\*min (squamous)

Treatment: Drugs: cisplatin
75 mg/m\^2 every 3 weeks (non-squamous)

Treatment: Drugs: paclitaxel
200 mg/m\^2 every 3 weeks (squamous)

Treatment: Drugs: nab-paclitaxel
100 mg/m\^2 on Days 1, 8, and 15 of every cycle (squamous)

Treatment: Drugs: pemetrexed
500 mg/m\^2 every 3 weeks (non-squamous)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1 (Safety Run-in): Number of Participants With Dose-limiting Toxicities (DLTs)
Timepoint [1] 0 0
During the first 42 days of dosing
Primary outcome [2] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Progression-free Survival (PFS) Per Investigator Assessment Using RECIST v1.1
Timepoint [2] 0 0
18 months
Primary outcome [3] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Survival (OS) Per Investigator Assessment Using RECIST v1.1
Timepoint [3] 0 0
Up to approximately 32 months
Secondary outcome [1] 0 0
Part 1 (Safety Run-in): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1
Timepoint [1] 0 0
Up to approximately 14 months
Secondary outcome [2] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1
Timepoint [2] 0 0
Up to approximately 26 months
Secondary outcome [3] 0 0
Part 1 (Safety run-in): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1
Timepoint [3] 0 0
Up to approximately 14 months
Secondary outcome [4] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1
Timepoint [4] 0 0
Up to approximately 26 months
Secondary outcome [5] 0 0
Part 1 (Safety run-in): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1
Timepoint [5] 0 0
Up to approximately 25 months
Secondary outcome [6] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1
Timepoint [6] 0 0
Up to approximately 26 months
Secondary outcome [7] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Response (TTR) Per Investigator Assessment Using RECIST v1.1
Timepoint [7] 0 0
Up to approximately 26 months
Secondary outcome [8] 0 0
Part 1 (Safety Run-in): Antidrug Antibodies (ADA) of Canakinumab
Timepoint [8] 0 0
Predose (0 hours (h)) on Day 1 of Cycles 1, 4, 8, 12, 16 (Cycle length =21 days), at end of treatment & then at 26, 78 and 130 days after last dose
Secondary outcome [9] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Number of Participants With Antidrug Antibodies (ADA) of Canakinumab
Timepoint [9] 0 0
Up to approximately 26 months
Secondary outcome [10] 0 0
Part 1 (Safety run-in): Antidrug Antibodies (ADAs) of Pembrolizumab
Timepoint [10] 0 0
Predose (0 h) on Day 1 of Cycles 1, 2, 4, 8, 12, 16 (Cycle length =21 days), at end of treatment & then at 26 days after last dose
Secondary outcome [11] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Antidrug Antibodies (ADA) of Pembrolizumab
Timepoint [11] 0 0
Up to approximately 26 months
Secondary outcome [12] 0 0
Part 1 (Safety Run-in): Serum Canakinumab Concentration
Timepoint [12] 0 0
Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, Post dose on Cycle 5 day 8, at end of treatment & then at 26, 78 and 130 days after last dose (Cycle length =21 days)
Secondary outcome [13] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration
Timepoint [13] 0 0
Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, Post dose on Cycle 5 day 8, at end of treatment & then at 26, 78 and 130 days after last dose (Cycle length =21 days)
Secondary outcome [14] 0 0
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration
Timepoint [14] 0 0
Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, at end of treatment & then at 26 days after last dose (Cycle length =21 days)
Secondary outcome [15] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration
Timepoint [15] 0 0
Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, at end of treatment & then at 26 days after last dose (Cycle length =21 days)
Secondary outcome [16] 0 0
Part 1 (Safety Run-in): Plasma Pemetrexed Concentration
Timepoint [16] 0 0
Predose (0 h) and end of infusion on Cycle 1 and 2; 1, 4, 8 h post infusion on Cycle 1; 1, 2, 4, 8h post infusion on Cycle 2 (Cycle length =21 days)
Secondary outcome [17] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Pemetrexed Concentration
Timepoint [17] 0 0
Predose (0 h) and end of infusion on Cycle 1 and 2; 1, 4, 8 h post infusion on Cycle 1; 1, 2, 4, 8h post infusion on Cycle 2 (Cycle length =21 days)
Secondary outcome [18] 0 0
Part 1 (Safety Run-in): Plasma Cisplatin Concentration
Timepoint [18] 0 0
Predose (0 h) and end of infusion on Cycle 1 and 2; 2, 4, 8 h post infusion on Cycle 1; 1.5, 2, 4, 8 h post infusion on Cycle 2 (Cycle length =21 days)
Secondary outcome [19] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Cisplatin Concentration
Timepoint [19] 0 0
Predose (0 h) and end of infusion on Cycle 1 and 2; 2, 4, 8 h post infusion on Cycle 1; 1.5, 2, 4, 8 h post infusion on Cycle 2 (Cycle length = 21 days)
Secondary outcome [20] 0 0
Part 1 (Safety Run-in): Plasma Carboplatin Concentration
Timepoint [20] 0 0
Predose (0 h), end of infusion, 1, 2, 4, 8 h post infusion on Cycles 1 and 2 (Cycle length =21 days)
Secondary outcome [21] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Carboplatin Concentration
Timepoint [21] 0 0
Predose (0 h), end of infusion, 1, 2, 4, 8 h post infusion on Cycles 1 and 2 (Cycle length =21 days)
Secondary outcome [22] 0 0
Part 1 (Safety Run-in): Plasma Paclitaxel Concentration
Timepoint [22] 0 0
Predose (0 h) and end of infusion on Cycle 1 and 2; 4, 8, 12 h post infusion on Cycle 1; 4, 6, 8, 12 h post infusion on Cycle 2 (Cycle length =21 days)
Secondary outcome [23] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Paclitaxel Concentration
Timepoint [23] 0 0
Predose (0 h) and end of infusion on Cycle 1 and 2; 4, 8, 12 h post infusion on Cycle 1; 4, 6, 8, 12 h post infusion on Cycle 2 (Cycle length =21 days)
Secondary outcome [24] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Nab-paclitaxel Concentration
Timepoint [24] 0 0
Predose (0 h) and end of infusion on Cy 1 and 2, 4, 8, 12 h post infusion on Cy 1, 4, 6, 8, 12 h post infusion on Cy 2 (Cy length =21 days)
Secondary outcome [25] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Definitive 10-point Deterioration (TTDD) Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire
Timepoint [25] 0 0
Up to approximately 25 months
Secondary outcome [26] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Definitive Deterioration in Global Health Status/Quality of Life, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire
Timepoint [26] 0 0
Up to approximately 25 months
Secondary outcome [27] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire
Timepoint [27] 0 0
Assessed every 3 weeks from Week 3 through Week 108, at follow-up visits 1, 2, 3, 4, and 5 (follow-up visits occurred every 26 days from week 108), and at 7 and 28 days post-disease progression, all up to a maximum of 3.5 years
Secondary outcome [28] 0 0
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS)
Timepoint [28] 0 0
Assessed every 3 weeks from Week 3 through Week 108, at follow-up visits 1, 2, 3, 4, and 5 (follow-up visits occurred every 26 days from week 108), and at 7 and 28 days post-disease progression, all up to a maximum of 3.5 years
Secondary outcome [29] 0 0
All Collected Deaths
Timepoint [29] 0 0
On-treatment deaths: Up to approximately 29 months in Part 1 or approximately 25 months in Part 2. Post-treatment survival follow-up deaths: Up to an additional 130 days.

Eligibility
Key inclusion criteria
Key inclusion criteria:

* Histologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting
* Known PD-L1 status determined by a Novartis designated central laboratory. A newly obtained tissue biopsy or an archival biopsy (block or slides) is required for PD-L1 determination (PD-L1 IHC 22C3 pharmDx assay), prior to study randomization. Note: For the safety run-in part, known PD-L1 status is not required.
* Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.
* At least 1 measurable lesion by RECIST 1.1

Key exclusion criteria:

* Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways).
* Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1ß 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.
* Previously untreated or symptomatic central nervous system (CNS) metastases or lepto-meningeal disease.
* Subject with suspected or proven immune-compromised state or infections.
* Subject has prior to starting study drug: received live vaccination =3 months, had major surgery =4 weeks prior to starting study drug, has thoracic radiotherapy: lung fields = 4 weeks, other anatomic sites = 2 weeks, palliative radiotherapy for bone lesions = 2 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/06/2027
Actual
Sample size
Target
Accrual to date
Final
673
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [2] 0 0
Novartis Investigative Site - Wooloongabba
Recruitment hospital [3] 0 0
Novartis Investigative Site - Melbourne
Recruitment hospital [4] 0 0
Novartis Investigative Site - Murdoch
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4102 - Wooloongabba
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
Argentina
State/province [4] 0 0
Buenos Aires
Country [5] 0 0
Austria
State/province [5] 0 0
Oberoesterreich
Country [6] 0 0
Austria
State/province [6] 0 0
Salzburg
Country [7] 0 0
Brazil
State/province [7] 0 0
SP
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Chile
State/province [10] 0 0
Region De La Araucania
Country [11] 0 0
Chile
State/province [11] 0 0
Santiago
Country [12] 0 0
China
State/province [12] 0 0
Heilongjiang
Country [13] 0 0
China
State/province [13] 0 0
Hubei
Country [14] 0 0
China
State/province [14] 0 0
Hunan
Country [15] 0 0
China
State/province [15] 0 0
Jilin
Country [16] 0 0
China
State/province [16] 0 0
Shanxi
Country [17] 0 0
China
State/province [17] 0 0
Zhejiang
Country [18] 0 0
China
State/province [18] 0 0
Beijing
Country [19] 0 0
Colombia
State/province [19] 0 0
Cesar
Country [20] 0 0
Czechia
State/province [20] 0 0
Czech Republic
Country [21] 0 0
Czechia
State/province [21] 0 0
Brno Bohunice
Country [22] 0 0
Czechia
State/province [22] 0 0
Ostrava Vitkovice
Country [23] 0 0
Czechia
State/province [23] 0 0
Praha
Country [24] 0 0
Denmark
State/province [24] 0 0
Herning
Country [25] 0 0
Finland
State/province [25] 0 0
Oulu
Country [26] 0 0
France
State/province [26] 0 0
Bouches Du Rhone
Country [27] 0 0
France
State/province [27] 0 0
Lyon
Country [28] 0 0
France
State/province [28] 0 0
Montpellier
Country [29] 0 0
France
State/province [29] 0 0
Nantes Cedex 1
Country [30] 0 0
France
State/province [30] 0 0
Paris
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Dresden
Country [33] 0 0
Germany
State/province [33] 0 0
Essen
Country [34] 0 0
Germany
State/province [34] 0 0
Georgsmarienhuette
Country [35] 0 0
Germany
State/province [35] 0 0
Gerlingen
Country [36] 0 0
Germany
State/province [36] 0 0
Gottingen
Country [37] 0 0
Germany
State/province [37] 0 0
Halle (Saale)
Country [38] 0 0
Germany
State/province [38] 0 0
Heidelberg
Country [39] 0 0
Germany
State/province [39] 0 0
Koeln
Country [40] 0 0
Germany
State/province [40] 0 0
Leipzig
Country [41] 0 0
Germany
State/province [41] 0 0
Muenchen
Country [42] 0 0
Greece
State/province [42] 0 0
GR
Country [43] 0 0
Greece
State/province [43] 0 0
Athens
Country [44] 0 0
Hong Kong
State/province [44] 0 0
Kowloon
Country [45] 0 0
Hungary
State/province [45] 0 0
Veszprem
Country [46] 0 0
Iceland
State/province [46] 0 0
Reykjavik
Country [47] 0 0
India
State/province [47] 0 0
Andhra Pradesh
Country [48] 0 0
India
State/province [48] 0 0
Haryana
Country [49] 0 0
India
State/province [49] 0 0
Maharashtra
Country [50] 0 0
India
State/province [50] 0 0
Rajasthan
Country [51] 0 0
India
State/province [51] 0 0
Telangana
Country [52] 0 0
India
State/province [52] 0 0
West Bengal
Country [53] 0 0
Italy
State/province [53] 0 0
AV
Country [54] 0 0
Italy
State/province [54] 0 0
GE
Country [55] 0 0
Italy
State/province [55] 0 0
MI
Country [56] 0 0
Italy
State/province [56] 0 0
MO
Country [57] 0 0
Italy
State/province [57] 0 0
PD
Country [58] 0 0
Italy
State/province [58] 0 0
PG
Country [59] 0 0
Italy
State/province [59] 0 0
PR
Country [60] 0 0
Italy
State/province [60] 0 0
TO
Country [61] 0 0
Japan
State/province [61] 0 0
Aichi
Country [62] 0 0
Japan
State/province [62] 0 0
Hokkaido
Country [63] 0 0
Japan
State/province [63] 0 0
Hyogo
Country [64] 0 0
Japan
State/province [64] 0 0
Kanagawa
Country [65] 0 0
Japan
State/province [65] 0 0
Osaka
Country [66] 0 0
Japan
State/province [66] 0 0
Shizuoka
Country [67] 0 0
Japan
State/province [67] 0 0
Tokyo
Country [68] 0 0
Japan
State/province [68] 0 0
Yamaguchi
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Korea
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Seocho Gu
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Seoul
Country [72] 0 0
Lebanon
State/province [72] 0 0
Ashrafieh
Country [73] 0 0
Lebanon
State/province [73] 0 0
Saida
Country [74] 0 0
Malaysia
State/province [74] 0 0
Pahang
Country [75] 0 0
Malaysia
State/province [75] 0 0
Sarawak
Country [76] 0 0
Malaysia
State/province [76] 0 0
Wilayah Persekutuan
Country [77] 0 0
Malaysia
State/province [77] 0 0
Kuala Lumpur
Country [78] 0 0
Netherlands
State/province [78] 0 0
Groningen
Country [79] 0 0
Norway
State/province [79] 0 0
Drammen
Country [80] 0 0
Philippines
State/province [80] 0 0
Metro Manila
Country [81] 0 0
Philippines
State/province [81] 0 0
Makati City
Country [82] 0 0
Philippines
State/province [82] 0 0
Quezon
Country [83] 0 0
Philippines
State/province [83] 0 0
San Juan City
Country [84] 0 0
Poland
State/province [84] 0 0
Gliwice
Country [85] 0 0
Poland
State/province [85] 0 0
Poznan
Country [86] 0 0
Poland
State/province [86] 0 0
Tomaszw Mazowiecki
Country [87] 0 0
Portugal
State/province [87] 0 0
Lisboa
Country [88] 0 0
Portugal
State/province [88] 0 0
Porto
Country [89] 0 0
Romania
State/province [89] 0 0
Dolj
Country [90] 0 0
Romania
State/province [90] 0 0
Cluj-Napoca
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Arkhangelsk
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Omsk
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Pushkin Saint Petersburg
Country [94] 0 0
Russian Federation
State/province [94] 0 0
Saint Petersburg
Country [95] 0 0
Russian Federation
State/province [95] 0 0
St Petersburg
Country [96] 0 0
Singapore
State/province [96] 0 0
Singapore
Country [97] 0 0
Slovakia
State/province [97] 0 0
Slovak Republic
Country [98] 0 0
Slovakia
State/province [98] 0 0
Partizanske
Country [99] 0 0
Spain
State/province [99] 0 0
Andalucia
Country [100] 0 0
Spain
State/province [100] 0 0
Catalunya
Country [101] 0 0
Spain
State/province [101] 0 0
Pais Vasco
Country [102] 0 0
Spain
State/province [102] 0 0
Las Palmas de Gran Canaria
Country [103] 0 0
Spain
State/province [103] 0 0
Madrid
Country [104] 0 0
Spain
State/province [104] 0 0
Valencia
Country [105] 0 0
Spain
State/province [105] 0 0
Zaragoza
Country [106] 0 0
Sweden
State/province [106] 0 0
Stockholm
Country [107] 0 0
Switzerland
State/province [107] 0 0
Basel
Country [108] 0 0
Taiwan
State/province [108] 0 0
Kaohsiung
Country [109] 0 0
Taiwan
State/province [109] 0 0
Tainan
Country [110] 0 0
Taiwan
State/province [110] 0 0
Taipei
Country [111] 0 0
Taiwan
State/province [111] 0 0
Taoyuan
Country [112] 0 0
Thailand
State/province [112] 0 0
Hat Yai
Country [113] 0 0
Thailand
State/province [113] 0 0
THA
Country [114] 0 0
Thailand
State/province [114] 0 0
Bangkok
Country [115] 0 0
Turkey
State/province [115] 0 0
Ankara
Country [116] 0 0
Turkey
State/province [116] 0 0
Edirne
Country [117] 0 0
Turkey
State/province [117] 0 0
Istanbul
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Newcastle Upon Tyne
Country [119] 0 0
United Kingdom
State/province [119] 0 0
London
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Manchester
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Plymouth
Country [122] 0 0
Vietnam
State/province [122] 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 is currently 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/NCT03631199