Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
Start Date
4/11/2024
Completion Date
12/28/2029
Summary
The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.
Detailed Description
This is a Phase III, randomized, open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig monotherapy compared with Pembrolizumab monotherapy for the first-line treatment of participants with locally-advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Datopotamab Deruxtecan
Rilvegostomig
Pembrolizumab
Conditions
Locations
Research Site
Anchorage, Alaska 99508
United States
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Tucson, Arizona 85719
United States
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Little Rock, Arkansas 72205
United States
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Springdale, Arkansas 72762
United States
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Anaheim, California 92801
United States
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Beverly Hills, California 90211
United States
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Fountain Valley, California 92708
United States
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Newport Beach, California 92663
United States
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Clermont, Florida 34711
United States
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Gainesville, Florida 32608
United States
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Miami Beach, Florida 33140
United States
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Orange City, Florida 32763
United States
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Orlando, Florida 32806
United States
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Orlando, Florida 32827
United States
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West Palm Beach, Florida 33401
United States
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Atlanta, Georgia 30303
United States
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Atlanta, Georgia 30318
United States
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Atlanta, Georgia 30322
United States
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Atlanta, Georgia 30342
United States
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Hinsdale, Illinois 60521
United States
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Noblesville, Indiana 46062
United States
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Paducah, Kentucky 42003
United States
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Annapolis, Maryland 21401
United States
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Boston, Massachusetts 02114
United States
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Boston, Massachusetts 02215
United States
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Dearborn, Michigan 48126
United States
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Farmington Hills, Michigan 48334
United States
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Grand Rapids, Michigan 49503
United States
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Traverse City, Michigan 49684
United States
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Hattiesburg, Mississippi 39401
United States
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Kansas City, Missouri 64132
United States
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Bozeman, Montana 59715
United States
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Grand Island, Nebraska 68803
United States
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Omaha, Nebraska 68130
United States
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Las Vegas, Nevada 89102
United States
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Reno, Nevada 89502
United States
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Voorhees Township, New Jersey 08043
United States
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Stony Brook, New York 11794
United States
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Greenville, North Carolina 27834
United States
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Salisbury, North Carolina 28144
United States
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Cincinnati, Ohio 45219
United States
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Columbus, Ohio 43210
United States
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Maumee, Ohio 43537
United States
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Toledo, Ohio 43623
United States
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Portland, Oregon 97213
United States
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Greenville, South Carolina 29607
United States
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Sioux Falls, South Dakota 57105
United States
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Chattanooga, Tennessee 37404
United States
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Knoxville, Tennessee 37920
United States
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Fort Worth, Texas 76104
United States
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Houston, Texas 77030
United States
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Houston, Texas 77030
United States
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Houston, Texas 77090
United States
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Kingwood, Texas 77339
United States
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Odessa, Texas 79761
United States
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Fort Belvoir, Virginia 22060
United States
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Leesburg, Virginia 20176
United States
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Midlothian, Virginia 23114
United States
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Richmond, Virginia 23230
United States
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Tacoma, Washington 98405
United States
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Vancouver, Washington 98684
United States
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Wenatchee, Washington 98801
United States
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Appleton, Wisconsin 54911
United States
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Birtinya, 4575
Australia
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Blacktown, 2148
Australia
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Clayton, 3168
Australia
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Gosford, 2250
Australia
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Melbourne, 3000
Australia
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South Brisbane, QL 4101
Australia
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Wodonga, 3690
Australia
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Innsbruck, 6020
Austria
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Krems, 3500
Austria
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Linz, 4020
Austria
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Rankweil, 6830
Austria
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Vienna, 1140
Austria
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Vienna, 1210
Austria
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Wels, 4600
Austria
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Anderlecht, 1070
Belgium
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Bruges, 8000
Belgium
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Hasselt, 3500
Belgium
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La Louvière, 7100
Belgium
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Liège, 4000
Belgium
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Barretos, 14784-400
Brazil
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Curitiba, 80730-150
Brazil
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Florianópolis, 88034-000
Brazil
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Ipatinga, 35162-189
Brazil
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Natal, 59075-740
Brazil
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Porto Alegre, 91350-200
Brazil
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Rio de Janeiro, 22211-230
Brazil
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Santa Maria, 97015-450
Brazil
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São Paulo, 01221-020
Brazil
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Taubaté, 12030-200
Brazil
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Vancouver, British Columbia VSZ 4E6
Canada
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Winnipeg, Manitoba R3E 0V9
Canada
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St. John's, Newfoundland and Labrador A1B 3V6
Canada
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London, Ontario N6A 4L6
Canada
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Newmarket, Ontario L3Y 2P9
Canada
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Oshawa, Ontario L1G 2B9
Canada
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Toronto, Ontario M4N 3M5
Canada
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Lévis, Quebec G6V 0B8
Canada
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Montreal, Quebec H3T 1E2
Canada
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Montreal, Quebec H3T 1M5
Canada
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Montreal, Quebec H4J 1C5
Canada
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Rimouski, Quebec G5L 5T1
Canada
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Trois-Rivières, Quebec G8Z 3R9
Canada
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Saskatoon, Saskatchewan S7N 4H4
Canada
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Chicoutimi, G7H 5H6
Canada
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Beijing, 100142
China
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Beijing, 101149
China
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Changchun, 130000
China
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Changsha, 410013
China
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Chengdu, 610000
China
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Chengdu, 610041
China
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Chongqing, 400030
China
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Fuzhou, 350014
China
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Guangzhou, 510080
China
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Hangzhou, 310006
China
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Hangzhou, 310016
China
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Hangzhou, 310022
China
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Harbin, 150049
China
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Hefei, 230031
China
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Hefei, 230601
China
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Jinan, 250117
China
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Jining, 272011
China
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Kunming, 650118
China
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Lanzhou, 730000
China
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Linhai, 317000
China
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Linyi, 276001
China
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Nanjing, 210009
China
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Nanning, 530000
China
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Nanning, 530021
China
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Shanghai, 200030
China
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Shanghai, 200032
China
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Shanghai, 200433
China
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Shenyang, 110022
China
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Taiyuan, 030000
China
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Tianjin, 300060
China
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Wenzhou, 325000
China
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Wuhan, 430000
China
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Wuhan, 430010
China
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Wuhan, 430022
China
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Wuhan, 430030
China
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Xi'an, 710061
China
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Yangzhou, 225001
China
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Zhengzhou, 450000
China
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Zhengzhou, 450008
China
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Berlin, 10249
Germany
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Bonn, 53113
Germany
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Cologne, 50677
Germany
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Düsseldorf, 40489
Germany
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Essen, 45136
Germany
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Freiburg im Breisgau, 79106
Germany
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Gauting, 82131
Germany
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Georgsmarienhütte, 49124
Germany
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Gera, 07548
Germany
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Gütersloh, 33332
Germany
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Hamburg, 20251
Germany
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Hamburg, 22087
Germany
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Heidelberg, 69126
Germany
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Kempten, 87439
Germany
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Kiel, 24116
Germany
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Koblenz, 56068
Germany
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Ludwigsburg, 71640
Germany
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München, 81925
Germany
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Nuremberg, 90419
Germany
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Potsdam, 14467
Germany
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Ravensburg, 88212
Germany
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Budapest, 1121
Hungary
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Gyöngyös, 3200
Hungary
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Gyöngyös - Mátraháza, 3200
Hungary
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Győr, 9024
Hungary
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Gyula, 5700
Hungary
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Kecskemét, 6000
Hungary
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Salgótarján, 3100
Hungary
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Szekszárd, 7100
Hungary
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Székesfehérvár, 8000
Hungary
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Szolnok, 5000
Hungary
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Törökbálint, 2045
Hungary
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Chennai, 600031
India
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Dwārka, 110075
India
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Jaipur, 302004
India
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Kolkata, 700099
India
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Marg Jaipur, 302004
India
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Nagpur, 440001
India
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Nashik, 422011
India
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New Delhi, 110085
India
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New Delhi, 11029
India
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Surat, 395002
India
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Thiruvananthapuram, 695011
India
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Bergamo, 24125
Italy
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Genoa, 16132
Italy
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Milan, 20141
Italy
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Milan, 20162
Italy
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Monza, 20052
Italy
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Padova, 35128
Italy
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Pavia, 27100
Italy
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Ravenna, 48100
Italy
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Roma, 00128
Italy
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Rozzano, 20089
Italy
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Bunkyō City, 113-8431
Japan
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Bunkyō City, 160-0023
Japan
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Fukuoka, 812-8582
Japan
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Fukuoka, 814-0180
Japan
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Hakodate-shi, 040-8611
Japan
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Hidaka-shi, 350-1298
Japan
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Hirakata-shi, 573-1191
Japan
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Hirosaki-shi, 036-8563
Japan
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Hiroshima, 730-8518
Japan
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Kanazawa, 920-8641
Japan
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Kashiwa, 227-8577
Japan
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Kawasaki-shi, 216-8511
Japan
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Kumamoto, 860-8556
Japan
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Matsusaka-shi, 515-8544
Japan
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Nagoya, 460-0001
Japan
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Niigata, 951-8566
Japan
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Okayama, 700-8558
Japan
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Osaka, 545-8586
Japan
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Osakasayama-shi, 589-8511
Japan
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Sagamihara-shi, 252-0375
Japan
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Sapporo, 003-0804
Japan
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Takaoka-shi, 933-8555
Japan
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Takatsuki-shi, 569-8686
Japan
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Tokushima, 770-8503
Japan
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Tokyo, 104-0045
Japan
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Utsunomiya, 320-0834
Japan
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Yokohama, 221-0855
Japan
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Olsztyn, 10-357
Poland
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Poznan, 60-569
Poland
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Przemyśl, 37-700
Poland
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Warsaw, 01-138
Poland
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Warsaw, 02-781
Poland
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San Juan, 00909
Puerto Rico
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Changwon, 51353
South Korea
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Incheon, 21565
South Korea
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Seongnam-si, 13496
South Korea
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Seoul, 03080
South Korea
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Seoul, 03722
South Korea
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Seoul, 06973
South Korea
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Suwon, 16247
South Korea
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Suwon, 16499
South Korea
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Alicante, 03010
Spain
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Barcelona, 08003
Spain
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Barcelona, 08036
Spain
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Barcelona, 08041
Spain
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Jerez de la Frontera, 11407
Spain
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Reus, 43204
Spain
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Salamanca, 37007
Spain
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Kaohsiung City, 80756
Taiwan
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New Taipei City, 220
Taiwan
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Taichung, 40447
Taiwan
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Taichung, 40705
Taiwan
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Tainan, 704
Taiwan
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Taipei, 0116
Taiwan
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Taipei, 10002
Taiwan
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Taipei, 112
Taiwan
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Taipei, TAIWAN
Taiwan
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Taoyuan, 333
Taiwan
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Bangkok, 10400
Thailand
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Bangkok, 10700
Thailand
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Hat Yai, 90110
Thailand
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Muang, 22000
Thailand
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Mueang, 20000
Thailand
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Mueang, 32000
Thailand
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Adapazarı, 54100
Turkey (Türkiye)
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Ankara, 06560
Turkey (Türkiye)
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Ankara, 6200
Turkey (Türkiye)
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Antalya, 07070
Turkey (Türkiye)
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Diyarbakır, 21280
Turkey (Türkiye)
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Istanbul, 34030
Turkey (Türkiye)
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Istanbul, 34890
Turkey (Türkiye)
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Cheltenham, GL53 7AN
United Kingdom
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Inverness, IV2 3UJ
United Kingdom
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London, SE1 9RT
United Kingdom
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London, SW10 9NH
United Kingdom
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London, SW17 0QT
United Kingdom
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Norwich, NR4 7UY
United Kingdom
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Preston, PR2 9HT
United Kingdom
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Truro, TR1 3LJ
United Kingdom
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Da Nang, 550000
Vietnam
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Hanoi, 100000
Vietnam
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Hà Nội, 100000
Vietnam
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Ho Chi Minh City, 700000
Vietnam
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Ho Chi Minh City, 700000
Vietnam
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Huế, 530000
Vietnam
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Vinh, 460000
Vietnam
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Vĩnh Yên, 280000
Vietnam