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

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)

ClinicalTrials.gov Identifier: NCT03631199

Novartis Reference Number: CACZ885U2301

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects.

The study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.

Condition 
Non-small Cell Lung Cancer
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
673 participants
Start date 
Dec 21, 2018
Completion date 
Sep 22, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
canakinumab
canakinumab every 3 weeks (squamous and non-squamous)
Drug
canakinumab matching placebo
canakinumab placebo every 3 weeks (squamous and non-squamous)
Drug
pembrolizumab
200 mg every 3 weeks (squamous and non-squamous)
Drug
carboplatin
AUC 5 mg/mL*min every 3 weeks (non-squamous) or AUC 6 mg/mL*min (squamous)
Drug
cisplatin
75 mg/m2 every 3 weeks (non-squamous)
Drug
paclitaxel
200 mg/m2 every 3 weeks (squamous)
Drug
nab-paclitaxel
100 mg/m2 every 3 weeks (squamous)
Drug
pemetrexed
500 mg/m2 every 3 weeks (non-squamous)

Eligibility 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-1β 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

United States
Pacific Shores Medical Group
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Long Beach, 90813
California
United States
USC Kenneth Norris Comprehensive Cancer Center
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Los Angeles, 90033
California
United States
Advent Health Cancer Institute
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Orlando, 32804
Florida
United States
Dana Farber Cancer Institute
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Boston, 02215
Massachusetts
United States
Argentina
Novartis Investigative Site
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Caba, C1426ANZ
Buenos Aires
Argentina
Novartis Investigative Site
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Buenos Aires, C1431FWO
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Argentina
Australia
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Westmead, 2145
New South Wales
Australia
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Wooloongabba, 4102
Queensland
Australia
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Melbourne, 3000
Victoria
Australia
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Murdoch, 6150
Western Australia
Australia
Austria
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Linz, A 4020
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Austria
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Salzburg, 5020
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Austria
Brazil
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Barretos, 14784 400
SP
Brazil
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Sao Paulo, 01246 000
SP
Brazil
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Sao Paulo, 03102-002
SP
Brazil
Canada
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Edmonton, T6G 1Z2
Alberta
Canada
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Brampton, L6R 3J7
Ontario
Canada
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Toronto, M5G 1Z6
Ontario
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Chile
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Temuco, 4810469
Region De La Araucania
Chile
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Santiago, 8420383
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Chile
China
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Harbin, 150081
Heilongjiang
China
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Wuhan, 430022
Hubei
China
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Wuhan, 430030
Hubei
China
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Changsha, 410013
Hunan
China
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Changchun, 130012
Jilin
China
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Xi'an, 710038
Shanxi
China
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Hangzhou, 310022
Zhejiang
China
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Beijing, 100036
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China
Colombia
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Valledupar, 5602310
Cesar
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Czechia
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Brno, 656 53
Czech Republic
Czechia
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Prague 2, 128 00
Czech Republic
Czechia
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Brno - Bohunice, 639 01
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Czechia
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Ostrava Vitkovice, 703 84
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Czechia
Denmark
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Herning, DK-7400
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Denmark
Finland
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Oulu, FIN-90220
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Finland
France
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Marseille cedex 20, 13915
Bouches Du Rhone
France
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Lyon Cedex, 69373
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France
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Montpellier, 34070
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France
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Paris, 75231
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France
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Saint Herblain, 44800
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France
Germany
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Berlin, 13125
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Germany
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Dresden, 01307
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Germany
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Essen, 45147
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Germany
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Georgsmarienhuette, 49124
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Germany
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Gerlingen, 70839
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Germany
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Gottingen, 37075
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Germany
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Halle (Saale), 06120
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Germany
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Heidelberg, 69120
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Germany
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Koeln, 50937
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Germany
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Koeln, 51109
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Leipzig, 04357
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Muenchen, 81377
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Pune, 411013
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Jaipur, 302017
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Hyderabad, 500082
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Kolkata, 700160
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Avellino, 83100
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Milano, 20133
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Milano, 20141
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Rozzano, 20089
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Modena, 41100
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Gyeonggi do, 10408
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Seoul, 03080
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Seoul, 03722
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Seoul, 05505
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Lebanon
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Ashrafieh, 166830
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Lebanon
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Saida, 652
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Lebanon
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Kuantan, 25100
Pahang
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Kuching, 93586
Sarawak
Malaysia
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Kuala Lumpur, 50586
Wilayah Persekutuan
Malaysia
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Kuala Lumpur, 59100
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Malaysia
Netherlands
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Groningen, 9713 GZ
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Netherlands
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Groningen, 9728 NZ
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Netherlands
Norway
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Drammen, 3004
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Norway
Philippines
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Taguig City, 1634
Metro Manila
Philippines
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Makati City, 1229
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Philippines
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Quezon City, 1102
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Philippines
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San Juan City, 1500
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Philippines
Poland
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Gliwice, 44 101
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Poland
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Poznan, 60 569
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Poland
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Tomaszw Mazowiecki, 97-200
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Poland
Portugal
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Lisboa, 1769-001
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Portugal
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Porto, 4200-072
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Portugal
Romania
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Craiova, 200347
Dolj
Romania
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Cluj-Napoca, 400124
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Romania
Russian Federation
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Arkhangelsk, 163045
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Russian Federation
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Omsk, 644013
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Russian Federation
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Pushkin Saint Petersburg, 196603
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Russian Federation
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Saint Petersburg, 197022
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Russian Federation
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St Petersburg, 192148
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Russian Federation
Singapore
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Singapore, 119228
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Singapore
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Singapore, 169610
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Singapore
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Singapore, 308433
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Singapore
Slovakia
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Bratislava, 83310
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Slovakia
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Partizanske,
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Slovakia
Spain
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Granada, 18014
Andalucia
Spain
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Malaga, 29010
Andalucia
Spain
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Badalona, 08916
Catalunya
Spain
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Barcelona, 08035
Catalunya
Spain
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Barcelona, 08036
Catalunya
Spain
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Valencia, 46026
Comunidad Valenciana
Spain
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Las Palmas De Gran Canarias, 35016
Las Palmas De Gran Canaria
Spain
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San Sebastian, 20080
Pais Vasco
Spain
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Madrid, 28009
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Spain
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Madrid, 28040
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Spain
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Madrid, 28041
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Spain
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Madrid, 28046
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Spain
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Zaragoza, 50009
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Spain
Sweden
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Stockholm, 171 76
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Sweden
Switzerland
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Basel, 4031
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Switzerland
Taiwan
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Kaohsiung City, 83301
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Taiwan
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Tainan, 704
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Taiwan
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Taipei, 10002
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Taiwan
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Taipei, 11217
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Taiwan
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Taoyuan, 333
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Taiwan
Thailand
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Songkhla, 90110
Hat Yai
Thailand
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Khon Kaen, 40002
THA
Thailand
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Bangkok, 10330
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Thailand
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Bangkok, 10400
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Thailand
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Bangkok, 10700
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Thailand
Turkey
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Ankara, 06010
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Turkey
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Ankara, 06100
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Turkey
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Edirne, 22030
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Turkey
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Istanbul, 34214
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Turkey
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High Heaton, NE7 7DN
Newcastle Upon Tyne
United Kingdom
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London, NW3 2QG
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United Kingdom
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Manchester, M20 2BX
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United Kingdom
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Plymouth, PL6 8DH
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United Kingdom
Vietnam
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Hanoi, 100000
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Vietnam

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