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NCT06627647PHASE3Recruiting

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC

AstraZeneca

Start Date

11/27/2024

Completion Date

11/18/2030

Summary

The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC whose tumors express PD-L1.

Detailed Description

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a 1L treatment for patients with locally advanced or metastatic non-squamous NSCLC whose tumors express PD-L1 (TC ≥ 1%).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Histologically or cytologically documented non-squamous NSCLC. * Stage III B/C or IV NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment. * Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements. * Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved and available targeted 1L therapies. * Provision of acceptable tumor sample, to confirm tumor PD-L1 expression TC ≥ 1%. * At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements. * Adequate organ and bone marrow function Exclusion Criteria: * Presence of small cell and neuroendocrine histology components. * Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization. * Any prior systemic therapy received for NSCLC except in the neoadjuvant or adjuvant setting or definitive chemoradiotherapy with the intent to cure, provided that progression has occurred \> 12 months after the end of systemic therapy treatment. * Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms. * Any prior treatment with an anti-PD-1 or anti-PD-L1 agent. * History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. * Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs. * Active primary immunodeficiency/active infectious disease(s). * Active tuberculosis infection.

Interventions

DRUG

Rilvegostomig

DRUG

Pembrolizumab

DRUG

Carboplatin

DRUG

Cisplatin

DRUG

Pemetrexed

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Conditions

Non-squamous Non-small Cell Lung Cancer

Locations

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Mobile, Alabama 36608

United States

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Chandler, Arizona 85224

United States

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Phoenix, Arizona 85054

United States

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Anaheim, California 92801

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Beverly Hills, California 90211

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Loma Linda, California 92350

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Redlands, California 92373

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San Diego, California 92123

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San Francisco, California 94121

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Santa Rosa, California 95403

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Walnut Creek, California 94598

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Lone Tree, Colorado 80124

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Stamford, Connecticut 06902

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West Haven, Connecticut 06516

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Newark, Delaware 19713

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Bay Pines, Florida 33744

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Fort Lauderdale, Florida 33308

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Gainesville, Florida 32610

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Jacksonville, Florida 32224

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Miami, Florida 33125

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Ocala, Florida 34474

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St. Petersburg, Florida 33709

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Atlanta, Georgia 30342

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Boise, Idaho 83712

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Chicago, Illinois 60637

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Decatur, Illinois 62526

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Hinsdale, Illinois 60521

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Quincy, Illinois 62305

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Rockford, Illinois 61114

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Waterloo, Iowa 50702

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Lexington, Kentucky 40509

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Lexington, Kentucky 40536

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Louisville, Kentucky 40207

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Alexandria, Louisiana 71301

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Baton Rouge, Louisiana 70808

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Shreveport, Louisiana 71103

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Shreveport, Louisiana 71105

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South Portland, Maine 04106

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Baltimore, Maryland 21202

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Grand Rapids, Michigan 49503

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Duluth, Minnesota 55805

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Rochester, Minnesota 55905

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Saint Paul, Minnesota 55102

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Bridgeton, Missouri 63044

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Columbia, Missouri 65212

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Lincoln, Nebraska 68506

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Camden, New Jersey 08103

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Buffalo, New York 14221

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Westbury, New York 11590

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Canton, Ohio 44710

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Medford, Oregon 97504

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Portland, Oregon 97239

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Salem, Oregon 97301

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Pittsburgh, Pennsylvania 15212

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York, Pennsylvania 17403

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Providence, Rhode Island 02903

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Pierre, South Dakota 57501

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Sioux Falls, South Dakota 57105

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Chattanooga, Tennessee 37404

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Nashville, Tennessee 37203

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Fort Worth, Texas 76104

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Houston, Texas 77090

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Irving, Texas 75063

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Kingwood, Texas 77339

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Lubbock, Texas 79410

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Palestine, Texas 75801

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Round Rock, Texas 78665

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Fairfax, Virginia 22031

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Norfolk, Virginia 23502

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Roanoke, Virginia 24014

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Seattle, Washington 98101

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Seattle, Washington 98104

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Silverdale, Washington 98383

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Spokane, Washington 99208

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Tacoma, Washington 98405

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Wenatchee, Washington 98801

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La Crosse, Wisconsin 54601

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Buenos Aires, C1431FWO

Argentina

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CABA, 1425

Argentina

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La Plata, 1900

Argentina

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Pilar, B1629ODT

Argentina

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Rosario, S2000DEJ

Argentina

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Darlinghurst, 2010

Australia

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Hyde Park, 4812

Australia

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Southport, 4215

Australia

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Wollongong, 2500

Australia

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Brussels, 1160

Belgium

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Charleroi, 6060

Belgium

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Kortrijk, 8500

Belgium

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Ottignies, 1340

Belgium

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Sint-Niklaas, 9100

Belgium

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Ijuí, 98700-000

Brazil

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Londrina, 86015-520

Brazil

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Passo Fundo, 99010-260

Brazil

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Porto Alegre, 91350-200

Brazil

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Salvador, 40050 410

Brazil

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São Paulo, 01246-000

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São Paulo, 01327-001

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São Paulo, 05652000

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Taubaté, 12030-200

Brazil

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Vitória, 29043-260

Brazil

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Saint John, New Brunswick E2L 4L2

Canada

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Sydney, Nova Scotia B1P 1P3

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Hamilton, Ontario L8V 1C3

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Kingston, Ontario K7L 2V7

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Sault Ste. Marie, Ontario P6A 0A8

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Montreal, Quebec H2X 0A9

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Montreal, Quebec H4A 3J1

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Saint-Jérôme, Quebec J7Z 2V4

Canada

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Beijing, 100021

China

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Beijing, 100029

China

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Beijing, CN-100730

China

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Changchun, 130012

China

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Changsha, 410013

China

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Chengdu, 610041

China

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Chongqing, 400030

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Fuzhou, 350007

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Guangzhou, 510062

China

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Guangzhou, 510180

China

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Hangzhou, 310003

China

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Hangzhou, 310016

China

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Hangzhou, 310022

China

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Harbin, 150081

China

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Hefei, 230601

China

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Jinan, 250117

China

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Jingzhou, 434000

China

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Kunming, 650118

China

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Linhai, 317000

China

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Nanchang, 330008

China

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Ningbo, 315010

China

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Shanghai, 200030

China

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Shanghai, 200433

China

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Wenzhou, CN-325000

China

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Wuhan, 430000

China

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Xi'an, 710061

China

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Xiangyang, 441000

China

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Zhengzhou, 450008

China

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Zhengzhou, 450052

China

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Avignon, 84902

France

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La Rochelle, 17019

France

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Lyon, 69373

France

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Nîmes, 30029

France

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Rennes, 35033

France

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Strasbourg, 67091

France

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Suresnes, 92150

France

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Toulon, 83800

France

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Bad Berka, 99437

Germany

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Berlin, 13585

Germany

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Bielefeld, 33611

Germany

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Bochum, 44791

Germany

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Cologne, 51109

Germany

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Esslingen am Neckar, 73730

Germany

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Frankfurt, 60488

Germany

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Gauting, 82131

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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Hanover, 30459

Germany

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Hanover, 30625

Germany

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Hemer, 58675

Germany

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Homburg, 66424

Germany

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Kassel, 34125

Germany

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Kiel, 24105

Germany

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Krefeld, 47805

Germany

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Minden, 32429

Germany

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Moers, 47441

Germany

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München, 81925

Germany

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Regensburg, 93053

Germany

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Velbert, 42551

Germany

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Würzburg, 97067

Germany

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Budapest, 1083

Hungary

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Budapest, 1121

Hungary

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Budapest, 1122

Hungary

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Debrecen, 4032

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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Pécs, 7624

Hungary

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Székesfehérvár, 8000

Hungary

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Törökbálint, 2045

Hungary

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Calicut, 673601

India

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Delhi, 110029

India

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Kolkata, 700054

India

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Madurai, 625107

India

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Mumbai, 400012

India

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Nashik, 422002

India

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New Delhi, 110075

India

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Varanasi, 221005

India

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Florence, 50134

Italy

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Monza, 20052

Italy

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Peschiera del Garda, 37019

Italy

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Rome, 00168

Italy

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Amagasaki-shi, 660-8550

Japan

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Bunkyō City, 113-8603

Japan

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Chūōku, 104-0045

Japan

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Fukuoka, 812-8582

Japan

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Fukuoka, 814-0180

Japan

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Hiroshima, 734-8551

Japan

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Kawagoe-shi, 350-8550

Japan

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Kawasaki-shi, 216-8511

Japan

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Kitaadachi-gun, 362-0806

Japan

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Kitakyushu-shi, 807-8555

Japan

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Kobe, 650-0017

Japan

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Kōtoku, 135-8550

Japan

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Kumamoto, 860-8556

Japan

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Kumamoto, 861-4193

Japan

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Kyoto, 612-8555

Japan

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Matsusaka-shi, 515-8544

Japan

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Osaka, 541-8567

Japan

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Ota-shi, 373-8550

Japan

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Saitama-shi, 338-0001

Japan

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Sendai, 981-0914

Japan

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Shinjuku-ku, 160-0023

Japan

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Sunto-gun, 411-8777

Japan

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Takaoka-shi, 933-8555

Japan

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Yokohama, 232-0024

Japan

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Yokohama, 241-8515

Japan

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Kuala Lumpur, 59100

Malaysia

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Kuching, 93586

Malaysia

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Petaling Jaya, 47500

Malaysia

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Alkmaar, 1815 JD

Netherlands

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Ede, 6716 RP

Netherlands

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Groningen, 9713 GZ

Netherlands

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Leidschendam, 2262 BA

Netherlands

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Veldhoven, 5504 DB

Netherlands

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Lima, 15036

Peru

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Lima, 15102

Peru

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Lima, LIMA 29

Peru

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Lima, Lima 34

Peru

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Bialystok, 15-027

Poland

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Biała Podlaska, 21-500

Poland

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Bydgoszcz, 85-796

Poland

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Bystra, 43-360

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Lodz, 93-338

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Lublin, 20-090

Poland

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Poznan, 60-569

Poland

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Warsaw, 04-141

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Wroclaw, 53-413

Poland

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San Juan, 00918

Puerto Rico

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San Juan, 00935

Puerto Rico

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Gyeonggi-do, 13620

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, 07061

South Korea

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Songpa-gu, 05505

South Korea

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Barcelona, 8035

Spain

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Castellon, 12002

Spain

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Las Palmas de Gran Canaria, 35016

Spain

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Madrid, 28034

Spain

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Madrid, 28046

Spain

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Majadahonda, 28222

Spain

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Seville, 41013

Spain

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Kaohsiung City, 80756

Taiwan

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Kaohsiung City, 824

Taiwan

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New Taipei City, 220

Taiwan

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New Taipei City, 23561

Taiwan

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Taichung, 40201

Taiwan

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Taichung, 40705

Taiwan

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Tainan, 736

Taiwan

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Taoyuan, 333423

Taiwan

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Bangkok, 10700

Thailand

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Chiang Mai, 50200

Thailand

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Dusit, 10300

Thailand

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Nakhon Ratchasima, 30000

Thailand

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Songkhla, 90110

Thailand

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Ankara, 06010

Turkey (Türkiye)

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Antalya, 07070

Turkey (Türkiye)

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Antalya, 07100

Turkey (Türkiye)

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Edirne, 22030

Turkey (Türkiye)

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Izmir, 35965

Turkey (Türkiye)

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Seyhan, 1060

Turkey (Türkiye)

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Aberdeen, AB25 2ZN

United Kingdom

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Cambridge, CB2 0QQ

United Kingdom

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Edinburgh, EH4 2XU

United Kingdom

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Exeter, EX2 5DW

United Kingdom

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Greater London, SW3 6JJ

United Kingdom

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London, EC1A 7BE

United Kingdom

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London, SE1 9RT

United Kingdom

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Manchester, M20 4BX

United Kingdom

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Newcastle upon Tyne, NE7 7AF

United Kingdom

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Torquay, TQ2 7AA

United Kingdom

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Can Tho, 900000

Vietnam

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Hanoi, 100000

Vietnam

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Ho Chi Minh City, 700000

Vietnam

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Vinh, 460000

Vietnam