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NCT06692738PHASE3Recruiting

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

AstraZeneca

Start Date

11/18/2024

Completion Date

7/1/2030

Summary

The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (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 first-line (1L) treatment for patients with squamous locally advanced or metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Histologically or cytologically documented squamous NSCLC. * Stage III B/C or IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment. * Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any 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, non-curative therapy received for NSCLC. * Any prior treatment with an anti-PD-1 or anti-PD-L1 agent. * Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms. * 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 or other immunosuppressive drugs. * Active primary immunodeficiency/active infectious disease(s). * Active tuberculosis infection.

Interventions

DRUG

Rilvegostomig

DRUG

Pembrolizumab

DRUG

Carboplatin

DRUG

Paclitaxel

DRUG

Nab-paclitaxel

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Conditions

Non-small Cell Lung Cancer

Locations

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Tucson, Arizona 85724

United States

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Springdale, Arkansas 72762

United States

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Anaheim, California 92801

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Beverly Hills, California 90211

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Loma Linda, California 92354

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Los Alamitos, California 90720

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Redlands, California 92373

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San Francisco, California 94121

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Walnut Creek, California 94598

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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 32608

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Gainesville, Florida 32610

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Jacksonville, Florida 32224

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Athens, Georgia 30607

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Atlanta, Georgia 30341

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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 62301

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Rockford, Illinois 61114

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Fort Wayne, Indiana 46845

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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 40202

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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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Covington, Louisiana 70433

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Shreveport, Louisiana 71103

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Shreveport, Louisiana 71105

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Scarborough, Maine 04074

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Baltimore, Maryland 21202

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Bethesda, Maryland 20817

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Detroit, Michigan 48202

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Grand Rapids, Michigan 49503

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Saginaw, Michigan 48602

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Duluth, Minnesota 55802

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Rochester, Minnesota 55905

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Bridgeton, Missouri 63044

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Columbia, Missouri 65212

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Kansas City, Missouri 64108

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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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East Syracuse, New York 13057

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Westbury, New York 11590

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Wilson, North Carolina 27893

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Grand Forks, North Dakota 58201

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Cincinnati, Ohio 45267

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Bend, Oregon 97701

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Medford, Oregon 97504

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Salem, Oregon 97301

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Hershey, Pennsylvania 17033

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York, Pennsylvania 17403

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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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Kingwood, Texas 77339

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Lubbock, Texas 79410

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Round Rock, Texas 78665

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Fairfax, Virginia 22031

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Fredericksburg, Virginia 22408

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Olympia, Washington 98506

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Seattle, Washington 98101

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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

United States

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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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Innsbruck, 6020

Austria

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Krems, 3500

Austria

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Rankweil, 6830

Austria

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Vienna, 1160

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Vienna, 1210

Austria

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Anderlecht, 1070

Belgium

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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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Barretos, 14784-400

Brazil

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Florianópolis, 88034-000

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Ijuí, 98700-000

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Londrina, 86015-520

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Porto Alegre, 91350-200

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Salvador, 40050 410

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São Paulo, 01246-000

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São Paulo, 05652-900

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Taubaté, 12030-200

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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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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Beijing, 100021

China

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Beijing, 100029

China

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Beijing, 100142

China

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Beijing, 101149

China

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Beijing, CN-100730

China

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Changchun, 130012

China

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Changde, 415000

China

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Changsha, 410013

China

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Chengdu, 610041

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Chengdu, 610072

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Chongqing, 400030

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Dalian, 116001

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Guangzhou, 510062

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Guangzhou, 510100

China

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Hangzhou, 310003

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Hangzhou, 310016

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Hangzhou, 310022

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Harbin, 150081

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Hefei, 230001

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Hefei, 230601

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Jinan, 250117

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Kunming, 650118

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Linhai, 317000

China

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Linyi, 276001

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Nanchang, 330008

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Ningbo, 315010

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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, 110004

China

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Shenzhen, 518020

China

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Taiyuan, 030000

China

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Tianjin, 300050

China

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Wenzhou, CN-325000

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Wuhan, 430030

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Xi'an, 710061

China

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Yangzhou, 225001

China

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Yueyang, 414000

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, 69008

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

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Toulon, 83800

France

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Bad Berka, 99437

Germany

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Berlin, 13125

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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Heidelberg, 69126

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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Edelény, 3780

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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Puducherry, 605006

India

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Surat, 395017

India

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Varanasi, 221005

India

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Florence, 50134

Italy

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Monza, 20900

Italy

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Orbassano, 10043

Italy

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Padova, 35128

Italy

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Peschiera del Garda, 37019

Italy

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Roma, 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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Hirakata-shi, 573-1191

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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Sakai, 590-0197

Japan

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Sapporo, 006-8555

Japan

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Sendai, 981-0914

Japan

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Shinjuku-ku, 160-0023

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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George Town, 10450

Malaysia

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Johor Bahru, 81100

Malaysia

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Kuala Lumpur, 59100

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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Zwolle, 8025 AB

Netherlands

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Lima, 15036

Peru

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Lima, 15102

Peru

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Lima, 34

Peru

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Lima, L27

Peru

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Lima, LIMA 29

Peru

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Lima, Lima39

Peru

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Bialystok, 15-027

Poland

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Biała Podlaska, 21-500

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Bydgoszcz, 85-796

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Bystra, 43-360

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Lodz, 93-338

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Lublin, 20-090

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Poznan, 60-569

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Warsaw, 04-141

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Wroclaw, 53-413

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San Juan, 00909

Puerto Rico

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San Juan, 00918

Puerto Rico

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Changwon-si, 51353

South Korea

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Cheongju-si, 28644

South Korea

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Incheon, 21565

South Korea

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JinJoo, 52727

South Korea

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Seoul, 03080

South Korea

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Seoul, 03722

South Korea

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Seoul, 05505

South Korea

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Seoul, 06351

South Korea

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Suwon, 16247

South Korea

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Suwon, 16499

South Korea

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Barcelona, 8035

Spain

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Las Palmas de Gran Canaria, 35016

Spain

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Lleida, 25198

Spain

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Madrid, 28007

Spain

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Madrid, 28034

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, 402

Taiwan

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Taichung, 40705

Taiwan

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Tainan, 73657

Taiwan

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Taoyuan, 333

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, 6500

Turkey (Türkiye)

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Antalya, 07059

Turkey (Türkiye)

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Istanbul, 34098

Turkey (Türkiye)

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Yenimahalle, 06170

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

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Exeter, EX2 5DW

United Kingdom

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Greater London, SW3 6JJ

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London, EC1A 7BE

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London, SE1 9RT

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Manchester, M20 4BX

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Newcastle upon Tyne, NE7 7AF

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Preston, PR2 9HT

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