A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Start Date
10/4/2024
Completion Date
9/27/2028
Summary
This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).
Detailed Description
This is a Phase III, open-label, 3-arm, multicenter study assessing the effects of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in participants with epidermal growth factor receptor gene mutation (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on prior osimertinib treatment. Participants will be randomized in a 1:1:1 ratio to one of the following intervention groups: 1. Dato-DXd + osimertinib combination therapy 2. Dato-DXd monotherapy 3. Platinum-based doublet chemotherapy Participants will receive study intervention until Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) -defined radiological progression by the investigator, unacceptable toxicity, or other discontinuation criterion is met. After study intervention discontinuation, all participants will undergo an end of treatment (EoT) visit within 35 days of discontinuation and will be followed up for safety assessments 28 (+ 7) days after their last dose of study intervention.
Eligibility Criteria
Age Range: 18 years to 130 years
Interventions
Dato-DXd
Osimertinib
Pemetrexed
Carboplatin
Cisplatin
Conditions
Locations
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Fayetteville, Arkansas 72703
United States
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Duarte, California 91010
United States
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Fountain Valley, California 92708
United States
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La Jolla, California 92093
United States
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Los Angeles, California 90048
United States
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San Diego, California 92123
United States
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Colorado Springs, Colorado 80909
United States
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Fort Collins, Colorado 80528
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Washington D.C., District of Columbia 20007
United States
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Gainesville, Florida 32608
United States
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Jacksonville, Florida 32256
United States
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Athens, Georgia 30607
United States
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Chicago, Illinois 60611
United States
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Evanston, Illinois 60201
United States
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Louisville, Kentucky 40207
United States
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Baltimore, Maryland 21201
United States
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Bethesda, Maryland 20817
United States
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Boston, Massachusetts 02114
United States
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Boston, Massachusetts 02215
United States
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Detroit, Michigan 48202
United States
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Kansas City, Missouri 64132
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Omaha, Nebraska 68124
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Morristown, New Jersey 07960
United States
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Northfield, New Jersey 08225
United States
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New York, New York 10016
United States
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New York, New York 10065
United States
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The Bronx, New York 10461
United States
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Maumee, Ohio 43537
United States
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Philadelphia, Pennsylvania 19107
United States
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Pittsburgh, Pennsylvania 15232
United States
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Chattanooga, Tennessee 37404
United States
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Nashville, Tennessee 37203
United States
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Fairfax, Virginia 22031
United States
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Seattle, Washington 98104
United States
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Fitzroy, VIC3065
Australia
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Heidelberg, 3084
Australia
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Kogarah, 2217
Australia
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Liverpool, 2170
Australia
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Nedlands, 6009
Australia
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Port Macquarie, 2444
Australia
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St Leonards, 2065
Australia
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Westmead, 2145
Australia
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Woodville, 5011
Australia
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Woolloongabba, 4102
Australia
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Charleroi, 6060
Belgium
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Edegem, 2650
Belgium
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Ghent, 9000
Belgium
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Hasselt, 3500
Belgium
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Jette, 1090
Belgium
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La Louvière, 7100
Belgium
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Leuven, 3000
Belgium
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Namur, 5000
Belgium
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Roeselare, 8800
Belgium
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Barretos, 14784-400
Brazil
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Betim, 32671-550
Brazil
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Blumenau, 89010-340
Brazil
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Florianópolis, 88040-970
Brazil
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Itajaí, 88301-220
Brazil
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Pelotas, 96020-080
Brazil
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Porto Alegre, 90035-074
Brazil
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Porto Alegre, 90470-340
Brazil
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Porto Alegre, 90610-000
Brazil
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Rio de Janeiro, 22250-905
Brazil
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Rio de Janeiro, 22281-100
Brazil
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Rio de Janeiro, 22775-001
Brazil
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São Paulo, 01323-900
Brazil
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São Paulo, 01327-001
Brazil
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Brampton, Ontario L6R 3J7
Canada
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Newmarket, Ontario L3Y 2P9
Canada
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Toronto, Ontario M4N 3M5
Canada
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Toronto, Ontario M5G 1Z5
Canada
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Montreal, Quebec H4A 3J1
Canada
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Québec, Quebec G1R 2J6
Canada
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Baoding, 071000
China
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Beijing, 100005
China
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Beijing, 100034
China
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Beijing, 100044
China
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Beijing, 100050
China
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Beijing, 100142
China
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Beijing, 100730
China
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Beijing, 101199
China
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Bengbu, 233004
China
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Changchun, 130012
China
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Changchun, 130021
China
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Changsha, 410013
China
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Chengdu, 610041
China
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Deyang, 618000
China
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Ganzhou, 341099
China
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Guangzhou, 510180
China
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Hangzhou, 310003
China
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Hangzhou, 310022
China
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Hefei, 230001
China
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Hengyang, 421001
China
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Huaian, 223399
China
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Jinan, 250013
China
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Linyi, 276000
China
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Luoyang, 471003
China
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Luzhou, 646000
China
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Nanchang, 330006
China
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Nanjing, 210009
China
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Shanghai, 200433
China
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Shantou,
China
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Shenyang, 110004
China
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Shenyang, 110042
China
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Tianjin, 300201
China
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Tianjin, CN-300052
China
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Weifang, 261000
China
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Wuhan, 430060
China
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Zhengzhou, 450000
China
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Zhengzhou, 450001
China
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Zhengzhou, 450008
China
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Angers, 49933
France
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Avignon, 84902
France
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Bordeaux, 33076
France
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Caen, 14000
France
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Lille, 59037
France
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Montpellier, 34298
France
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Nantes, 44093
France
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Paris, 75014
France
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Paris, 75970
France
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Pessac, 33604
France
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Quimper, 29000
France
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Toulon Armees, 83800
France
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Toulouse, 31400
France
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Tours, 37000
France
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Villejuif, 94805
France
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Berlin, 12351
Germany
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Berlin-Zehlendorf, 14165
Germany
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Bonn, 53127
Germany
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Essen, 45122
Germany
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Georgsmarienhütte, 49124
Germany
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Giessen, 35392
Germany
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Großhansdorf, 22927
Germany
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Hamburg, 20251
Germany
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Hamburg, 21075
Germany
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Heidelberg, 69126
Germany
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Kempten, 87439
Germany
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Löwenstein, 74245
Germany
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Nuremberg, 90419
Germany
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Oldenburg, 26121
Germany
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Athens, 11526
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Athens, 11527
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Athens, 12462
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Athens, 18547
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Heraklion, 71110
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Thessaloniki, 552 36
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Thessaloniki, 56249
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Thessaloniki, 57001
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Thessaloniki, 57010
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Hong Kong, 999077
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Hong Kong, 999077
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Hong Kong,
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Hong Kong,
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Shatin, 00000
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Amravati, 444606
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Bhubaneswar, 751019
India
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Hyderabad, 500034
India
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Kolhāpur, 416234
India
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Mumbai, 400012
India
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Mysuru, 570017
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Namakkal, 637001
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Pune, 411001
India
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Raipur, 492001
India
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Rajasthan, 313001
India
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Ranchi, 834001
India
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Thane, 401107
India
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Trivandrum, 695011
India
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Varanasi, 221005
India
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Beersheba, 8410101
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Haifa, 3109601
Israel
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Haifa, 34362
Israel
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Jerusalem, 91031
Israel
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Jerusalem, 91120
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Kfar Saba, 4428164
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Petah Tikva, 49100
Israel
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Ramat Gan, 52621
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Tel Aviv, 62748
Israel
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Bari, 70124
Italy
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Milan, 20141
Italy
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Misterbianco, 95045
Italy
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Monza, 20090
Italy
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Naples, 80131
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Orbassano, 10043
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Padova, 35128
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Parma, 43126
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Perugia, 06100
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Roma, 00144
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Rozzano, 20089
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Verona, 37126
Italy
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Bunkyō City, 113-8431
Japan
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Bunkyō City, 113-8603
Japan
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Fukuoka, 812-8582
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Hiroshima, 734-8551
Japan
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Iruma-Gun, 350-0495
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Iwakuni-shi, 740-8510
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Kobe, 650-0046
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Kōtoku, 135-8550
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Kumamoto, 860-8556
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Kyoto, 602-8566
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Matsuyama, 791-0280
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Nagoya, 464-8681
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Nagoya, 466-8560
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Niigata, 951-8566
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Osaka, 534-0021
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Osaka, 541-8567
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Ōsaka-sayama, 589-8511
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Sendai, 981-0914
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Sunto-gun, 411-8777
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Toyoake-shi, 470-1192
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Utsunomiya, 320-0834
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Wakayama, 641-8510
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Yokohama, 236-0051
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Yokohama, 241-8515
Japan
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Alor Star, 05460
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Cheras, 56000
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Johor Bahru, 81100
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Kuala Lumpur, 59100
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Kuala Selangor, 46050
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Kuching, 93586
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Perai, 13700
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Petaling Jaya, 47500
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Amersfoort, 3813 TZ
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Amsterdam, 1066CX
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Harderwijk, 3844 DG
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Rotterdam, 3015 GD
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Zutphen, 7207 AE
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Bacolod, 6100
Philippines
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Cebu City, 6000
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Davao City, 8000
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Manila, 1000
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Quezon, 1102
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Quezon, 1104
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San Juan City, 1500
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Katowice, 40-519
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Krakow, 30-727
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Lodz, 90-302
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Olsztyn, 10-357
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Poznan, 60-569
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Braga, 4710
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Lisbon, 1500-650
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Loures, 2674-514
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Porto, 4099-001
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Porto, 4200-072
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Craiova, 200385
Romania
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Craiova, 200542
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Singapore, 168583
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Singapore, 217562
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Singapore, 308433
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Busan, 48108
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Chungcheongbuk-do, 28644
South Korea
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Goyang-si, 10408
South Korea
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Gyeonggi-do, 13620
South Korea
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Jinju, 52727
South Korea
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Seoul, 03080
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Seoul, 03722
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Seoul, 06351
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Seoul, 06591
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Seoul, 5505
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Suwon, 16247
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A Coruña, 15009
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Barakaldo, 48903
Spain
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Barcelona, 08003
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Barcelona, 08041
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El Palmar, 30120
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L'Hospitalet de Llobregat, 08908
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Madrid, 28027
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Madrid, 28046
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Majadahonda, 28222
Spain
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Málaga, 29004
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Oviedo, 33006
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Palma de Mallorca, 7120
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Pamplona, 31008
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Santander, 39008
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Santiago de Compostela-Coruña, 15706
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Seville, 41014
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Valencia, 46010
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Valencia, 46026
Spain
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Valladolid, 47003
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Changhua, 50006
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Kaohsiung City, 80756
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Taichung, 404
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Taichung, 40705
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Tainan, 70403
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Tainan, 73657
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Taipei, 100
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Taipei, 110
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Taipei, 112
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Bangkok, 10330
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Bangkok, 10400
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Bangkok, 10700
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Chiang Mai, 50200
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Hat Yai, 90110
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Khon Kaen, 40002
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Pathum Thani, 12120
Thailand
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Birmingham, B9 5SS
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Cambridge, CB2 0QQ
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Glasgow, G12 0YN
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Leicester, LE1 5WW
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London, EC1A 7BE
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Middlesbrough, TS4 3BW
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Hanoi, 100000
Vietnam