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NCT06417814PHASE3Recruiting

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

AstraZeneca

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

Inclusion Criteria: * Histologically or cytologically confirmed non-squamous NSCLC. * Must have evidence of documented pre-existing EGFRm information (EGFRm known to be associated with (epidermal growth factor receptor \[EGFR\] tyrosine kinase inhibitor \[TKis\] sensitivity \[Ex19del, L858R, G719X, S768I, or L861Q\], either alone or in combination with other EGFR mutations, which may include T790M). * Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as most recent line of treatment) in the adjuvant, locally advanced, or metastatic setting. * Less than or equal to (\<=2) prior lines of EGFR TKIs (osimertinib is the only permitted prior third generation EGFR TKI). * At least one lesion, not previously irradiated, that qualifies as a RECIST v1.1 TL at baseline and can be accurately measured at baseline. * World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate bone marrow reserve and organ function within 7 days before randomization. Exclusion Criteria: * Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the metastatic setting. Platinum-based chemotherapy in non-metastatic setting within 12 months prior to randomization. * History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention. * Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease. * Has significant third-space fluid retention (example \[eg.\], ascites or pleural effusion) as judged by the investigator and is not amenable for required repeated drainage. * History of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids or drug-induced ILD, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses. * Unstable spinal cord compression and/or unstable brain metastases. * Participants with symptomatic brain metastases (including leptomeningeal involvement). * Clinically significant corneal disease. * Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals, suspected infections or inability to rule out infections. Use of systemic antibiotics within 14 days of randomization. * Has known human immunodeficiency virus (HIV) infection that is not well controlled.

Interventions

DRUG

Dato-DXd

DRUG

Osimertinib

DRUG

Pemetrexed

DRUG

Carboplatin

DRUG

Cisplatin

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Conditions

Metastatic Non-small Cell Lung Cancer

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

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La Jolla, California 92093

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Los Angeles, California 90048

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San Diego, California 92123

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Colorado Springs, Colorado 80909

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Fort Collins, Colorado 80528

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Washington D.C., District of Columbia 20007

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Gainesville, Florida 32608

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Jacksonville, Florida 32256

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Athens, Georgia 30607

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Chicago, Illinois 60611

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Evanston, Illinois 60201

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Louisville, Kentucky 40207

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Baltimore, Maryland 21201

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Bethesda, Maryland 20817

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Boston, Massachusetts 02114

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Boston, Massachusetts 02215

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Detroit, Michigan 48202

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Kansas City, Missouri 64132

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Omaha, Nebraska 68124

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Morristown, New Jersey 07960

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Northfield, New Jersey 08225

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New York, New York 10016

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New York, New York 10065

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The Bronx, New York 10461

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Maumee, Ohio 43537

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Philadelphia, Pennsylvania 19107

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Pittsburgh, Pennsylvania 15232

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Chattanooga, Tennessee 37404

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Nashville, Tennessee 37203

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Fairfax, Virginia 22031

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Seattle, Washington 98104

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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

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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

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Rio de Janeiro, 22250-905

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Rio de Janeiro, 22281-100

Brazil

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Rio de Janeiro, 22775-001

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São Paulo, 01323-900

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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

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Toronto, Ontario M4N 3M5

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Toronto, Ontario M5G 1Z5

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Montreal, Quebec H4A 3J1

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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

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Beijing, 101199

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Bengbu, 233004

China

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Changchun, 130012

China

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Changchun, 130021

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Changsha, 410013

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Chengdu, 610041

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Deyang, 618000

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Ganzhou, 341099

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Guangzhou, 510180

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Hangzhou, 310003

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Hangzhou, 310022

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Hefei, 230001

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Hengyang, 421001

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Huaian, 223399

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Jinan, 250013

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Linyi, 276000

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Luoyang, 471003

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Luzhou, 646000

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Nanchang, 330006

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Nanjing, 210009

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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

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Weifang, 261000

China

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Wuhan, 430060

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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

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Bordeaux, 33076

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Caen, 14000

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Lille, 59037

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Montpellier, 34298

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Nantes, 44093

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Paris, 75014

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Paris, 75970

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Pessac, 33604

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Quimper, 29000

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Toulon Armees, 83800

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Toulouse, 31400

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Tours, 37000

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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

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Essen, 45122

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Georgsmarienhütte, 49124

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Giessen, 35392

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Großhansdorf, 22927

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Hamburg, 20251

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Hamburg, 21075

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Heidelberg, 69126

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Kempten, 87439

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Löwenstein, 74245

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Nuremberg, 90419

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Oldenburg, 26121

Germany

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Athens, 11526

Greece

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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

Greece

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Thessaloniki, 57001

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Thessaloniki, 57010

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Hong Kong, 999077

Hong Kong

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Hong Kong, 999077

Hong Kong

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Hong Kong,

Hong Kong

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Hong Kong,

Hong Kong

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Shatin, 00000

Hong Kong

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Amravati, 444606

India

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Bhubaneswar, 751019

India

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Hyderabad, 500034

India

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Kolhāpur, 416234

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Mumbai, 400012

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Mysuru, 570017

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Namakkal, 637001

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Pune, 411001

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Raipur, 492001

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Rajasthan, 313001

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Ranchi, 834001

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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

Israel

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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

Israel

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Kfar Saba, 4428164

Israel

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Petah Tikva, 49100

Israel

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Ramat Gan, 52621

Israel

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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

Italy

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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

Italy

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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

Japan

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Hiroshima, 734-8551

Japan

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Iruma-Gun, 350-0495

Japan

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Iwakuni-shi, 740-8510

Japan

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Kobe, 650-0046

Japan

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Kōtoku, 135-8550

Japan

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Kumamoto, 860-8556

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Kyoto, 602-8566

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Matsuyama, 791-0280

Japan

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Nagoya, 464-8681

Japan

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Nagoya, 466-8560

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Niigata, 951-8566

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Osaka, 534-0021

Japan

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Osaka, 541-8567

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Ōsaka-sayama, 589-8511

Japan

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Sendai, 981-0914

Japan

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Sunto-gun, 411-8777

Japan

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Toyoake-shi, 470-1192

Japan

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Utsunomiya, 320-0834

Japan

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Wakayama, 641-8510

Japan

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Yokohama, 236-0051

Japan

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Yokohama, 241-8515

Japan

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Alor Star, 05460

Malaysia

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Cheras, 56000

Malaysia

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Johor Bahru, 81100

Malaysia

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Kuala Lumpur, 59100

Malaysia

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Kuala Selangor, 46050

Malaysia

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Kuching, 93586

Malaysia

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Perai, 13700

Malaysia

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Petaling Jaya, 47500

Malaysia

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Amersfoort, 3813 TZ

Netherlands

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Amsterdam, 1066CX

Netherlands

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Harderwijk, 3844 DG

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Rotterdam, 3015 GD

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Zutphen, 7207 AE

Netherlands

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Bacolod, 6100

Philippines

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Cebu City, 6000

Philippines

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Davao City, 8000

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Manila, 1000

Philippines

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Quezon, 1102

Philippines

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Quezon, 1104

Philippines

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San Juan City, 1500

Philippines

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Katowice, 40-519

Poland

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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

Portugal

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Lisbon, 1500-650

Portugal

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Loures, 2674-514

Portugal

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Porto, 4099-001

Portugal

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Porto, 4200-072

Portugal

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Craiova, 200385

Romania

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Craiova, 200542

Romania

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Singapore, 168583

Singapore

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Singapore, 217562

Singapore

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Singapore, 308433

Singapore

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Busan, 48108

South Korea

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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

South Korea

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Seoul, 03722

South Korea

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Seoul, 06351

South Korea

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Seoul, 06591

South Korea

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Seoul, 5505

South Korea

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Suwon, 16247

South Korea

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A Coruña, 15009

Spain

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Barakaldo, 48903

Spain

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Barcelona, 08003

Spain

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Barcelona, 08041

Spain

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El Palmar, 30120

Spain

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L'Hospitalet de Llobregat, 08908

Spain

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Madrid, 28027

Spain

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Madrid, 28046

Spain

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Majadahonda, 28222

Spain

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Málaga, 29004

Spain

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Oviedo, 33006

Spain

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Palma de Mallorca, 7120

Spain

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Pamplona, 31008

Spain

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Santander, 39008

Spain

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Santiago de Compostela-Coruña, 15706

Spain

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Seville, 41014

Spain

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Valencia, 46010

Spain

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Valencia, 46026

Spain

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Valladolid, 47003

Spain

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Changhua, 50006

Taiwan

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Kaohsiung City, 80756

Taiwan

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New Taipei City, 23561

Taiwan

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Taichung, 404

Taiwan

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Taichung, 40705

Taiwan

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Tainan, 70403

Taiwan

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Tainan, 73657

Taiwan

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Taipei, 100

Taiwan

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Taipei, 110

Taiwan

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Taipei, 112

Taiwan

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Bangkok, 10330

Thailand

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Bangkok, 10400

Thailand

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Bangkok, 10700

Thailand

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Chiang Mai, 50200

Thailand

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Hat Yai, 90110

Thailand

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Khon Kaen, 40002

Thailand

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Pathum Thani, 12120

Thailand

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Birmingham, B9 5SS

United Kingdom

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Cambridge, CB2 0QQ

United Kingdom

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Glasgow, G12 0YN

United Kingdom

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Leicester, LE1 5WW

United Kingdom

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London, EC1A 7BE

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Manchester, M20 4BX

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Middlesbrough, TS4 3BW

United Kingdom

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Hanoi, 100000

Vietnam