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NCT06357533PHASE3Recruiting

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

AstraZeneca

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

Inclusion Criteria: * Histologically or cytologically documented non-squamous NSCLC. * Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation. * Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies. * Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers. * Known tumour PD-L1 expression status defined as TC ≥ 50% * At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline * ECOG performance status of 0 or 1 * Adequate bone marrow reserve and organ function Exclusion Criteria: * Prior systemic therapy for advanced/metastatic NSCLC. * Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant. * History of another primary malignancy within 3 years * Active or prior documented autoimmune or inflammatory disorders (with exceptions) * Any evidence of severe or uncontrolled disease that makes it undesirable for the participant to participate in the study or that would jeopardies compliance with the protocol. * Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage. * History of any ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, has current or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * Has significant pulmonary function compromise, as determined by the investigator * Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants. * History of leptomeningeal carcinomatosis * Known clinically significant corneal disease * Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled * History of active primary immunodeficiency

Interventions

DRUG

Datopotamab Deruxtecan

DRUG

Rilvegostomig

DRUG

Pembrolizumab

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Conditions

Non-Small Cell Lung Cancer

Locations

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Anchorage, Alaska 99508

United States

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Tucson, Arizona 85719

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Little Rock, Arkansas 72205

United States

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Springdale, Arkansas 72762

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Anaheim, California 92801

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Beverly Hills, California 90211

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Fountain Valley, California 92708

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Newport Beach, California 92663

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Clermont, Florida 34711

United States

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Gainesville, Florida 32608

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Miami Beach, Florida 33140

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Orange City, Florida 32763

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Orlando, Florida 32806

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Orlando, Florida 32827

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West Palm Beach, Florida 33401

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Atlanta, Georgia 30303

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Atlanta, Georgia 30318

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Atlanta, Georgia 30322

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Atlanta, Georgia 30342

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Hinsdale, Illinois 60521

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Noblesville, Indiana 46062

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Paducah, Kentucky 42003

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Annapolis, Maryland 21401

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Boston, Massachusetts 02114

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Boston, Massachusetts 02215

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Dearborn, Michigan 48126

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Farmington Hills, Michigan 48334

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Grand Rapids, Michigan 49503

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Traverse City, Michigan 49684

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Hattiesburg, Mississippi 39401

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Kansas City, Missouri 64132

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Bozeman, Montana 59715

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Grand Island, Nebraska 68803

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Omaha, Nebraska 68130

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Las Vegas, Nevada 89102

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Reno, Nevada 89502

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Voorhees Township, New Jersey 08043

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Stony Brook, New York 11794

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Greenville, North Carolina 27834

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Salisbury, North Carolina 28144

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Cincinnati, Ohio 45219

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Columbus, Ohio 43210

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Maumee, Ohio 43537

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Toledo, Ohio 43623

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Portland, Oregon 97213

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Greenville, South Carolina 29607

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Sioux Falls, South Dakota 57105

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Chattanooga, Tennessee 37404

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Knoxville, Tennessee 37920

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Fort Worth, Texas 76104

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Houston, Texas 77030

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Houston, Texas 77030

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Houston, Texas 77090

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Kingwood, Texas 77339

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Odessa, Texas 79761

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Fort Belvoir, Virginia 22060

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Leesburg, Virginia 20176

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Midlothian, Virginia 23114

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Richmond, Virginia 23230

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Tacoma, Washington 98405

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Vancouver, Washington 98684

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Wenatchee, Washington 98801

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Appleton, Wisconsin 54911

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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

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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

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Santa Maria, 97015-450

Brazil

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São Paulo, 01221-020

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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

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St. John's, Newfoundland and Labrador A1B 3V6

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London, Ontario N6A 4L6

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Newmarket, Ontario L3Y 2P9

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Oshawa, Ontario L1G 2B9

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Toronto, Ontario M4N 3M5

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Lévis, Quebec G6V 0B8

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Montreal, Quebec H3T 1E2

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Montreal, Quebec H3T 1M5

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Montreal, Quebec H4J 1C5

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Rimouski, Quebec G5L 5T1

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Trois-Rivières, Quebec G8Z 3R9

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Saskatoon, Saskatchewan S7N 4H4

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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