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NCT05211895PHASE3Recruiting

A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC

AstraZeneca

Start Date

2/18/2022

Completion Date

10/1/2030

Summary

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.

Eligibility Criteria

Age Range: 18 years to No maximum

INCLUSION CRITERIA: 1. Participant must be ≥ 18 years at the time of screening. 2. Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease 3. Provision of a tumour tissue sample obtained prior to CRT 4. Documented tumour PD-L1 status ≥ 1% by central lab 5. Documented EGFR and ALK wild-type status (local or central). 6. Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy 7. Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy 8. Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique. 9. WHO performance status of 0 or 1 at randomization 10. Adequate organ and marrow function EXCLUSION CRITERIA: 1. History of another primary malignancy, except for: * Malignancies treated with curative intent and adequate follow-up with no known active disease and have not required active treatment within the past 3 years before the first dose of study intervention and of low potential risk of recurrence. * Adequately resected non melanoma skin cancer or lentigo maligna without evidence of disease . * Adequately treated carcinoma in situ, including Ta tumors without evidence of disease. 2. Mixed small cell and non-small cell lung cancer histology. 3. Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC. 4. Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT. 5. Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy (excluding alopecia). 6. Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy. 7. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis 8. Active or prior documented autoimmune or inflammatory disorders (with exceptions) 9. Active EBV infection, or known or suspected chronic active EBV infection at screening 10. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

Interventions

DRUG

Durvalumab

DRUG

Domvanalimab

OTHER

Placebo

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Conditions

Non-Small Cell Lung Cancer

Locations

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Chandler, Arizona 85224

United States

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Phoenix, Arizona 85054

United States

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Fountain Valley, California 92708

United States

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Santa Rosa, California 95403

United States

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Washington D.C., District of Columbia 20016

United States

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Jacksonville, Florida 32224

United States

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Orlando, Florida 32804

United States

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Saint Augustine, Florida 32086

United States

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Macon, Georgia 31217

United States

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Elmhurst, Illinois 60126

United States

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Maywood, Illinois 60153

United States

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Naperville, Illinois 60540

United States

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Louisville, Kentucky 40202

United States

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Baltimore, Maryland 21224

United States

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Silver Spring, Maryland 20910

United States

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Ann Arbor, Michigan 48106-0995

United States

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Detroit, Michigan 48202

United States

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Minneapolis, Minnesota 55407

United States

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Rochester, Minnesota 55905

United States

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Reno, Nevada 89511

United States

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East Brunswick, New Jersey 08816

United States

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Florham Park, New Jersey 07932

United States

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Buffalo, New York 14221

United States

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Johnson City, New York 13790

United States

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Asheville, North Carolina 28805

United States

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Asheville, North Carolina 28806

United States

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Charlotte, North Carolina 28204

United States

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Winston-Salem, North Carolina 27157

United States

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Columbus, Ohio 43214

United States

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Columbus, Ohio 43219

United States

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Maumee, Ohio 43537

United States

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Oklahoma City, Oklahoma 73102

United States

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Pittsburgh, Pennsylvania 15212

United States

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Charleston, South Carolina 29401

United States

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Chattanooga, Tennessee 37404

United States

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Nashville, Tennessee 37203

United States

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Nashville, Tennessee 37232

United States

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Fort Sam Houston, Texas 78234

United States

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Kingwood, Texas 77339

United States

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Arlington, Virginia 22205

United States

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Fort Belvoir, Virginia 22060

United States

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Spokane Valley, Washington 99216

United States

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Appleton, Wisconsin 54911

United States

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Brussels, 1160

Belgium

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Edegem, 2650

Belgium

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Haine-Saint-Paul, 7100

Belgium

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Leuven, 3000

Belgium

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Liège, 4000

Belgium

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Sint-Niklaas, 9100

Belgium

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Barretos, 14784-400

Brazil

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Londrina, 86015-520

Brazil

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Porto Alegre, 91350200

Brazil

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Porto Velho, 76834-899

Brazil

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Rio de Janeiro, 20231-050

Brazil

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Santo André, 09060-650

Brazil

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São Paulo, 01221-900

Brazil

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São Paulo, 01236-030

Brazil

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São Paulo, 01310-000

Brazil

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São Paulo, 04556-100

Brazil

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Taubaté, 12030-200

Brazil

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Calgary, Alberta T2N 5G2

Canada

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Kelowna, British Columbia V1Y 5L3

Canada

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Laval, Quebec H7M 3L9

Canada

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Montreal, Quebec H4A 3J1

Canada

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Las Condes, 7560908

Chile

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Port Montt, 5500243

Chile

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Santiago, 7500713

Chile

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Santiago, 7520426

Chile

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Santiago, 7630370

Chile

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Santiago, 8241479

Chile

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Temuco, 4810218

Chile

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Aix-en-Provence, 13616

France

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Angers, 49055

France

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Bobigny, 93000

France

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Clermont-Ferrand, 63000

France

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Lille, 59000

France

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Paris, 75014

France

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Pau, 6400

France

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Quimper, 29000

France

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Saint-Grégoire, 35760

France

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Saint-Quentin, 02321

France

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Vantoux, 57070

France

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Villeurbanne, 69100

France

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Berlin, 12351

Germany

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Berlin-Zehlendorf, 14165

Germany

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Braunschweig, 38114

Germany

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Chemnitz, 09116

Germany

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Cologne, 51109

Germany

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Erlangen, 91054

Germany

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Essen, 45147

Germany

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Georgsmarienhütte, 49124

Germany

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Giessen, 35392

Germany

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Halle, 06120

Germany

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Hamburg, 21075

Germany

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Homburg, 66421

Germany

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Koblenz, 56073

Germany

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Krefeld, 47805

Germany

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Löwenstein, 74245

Germany

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Moers, 47441

Germany

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München, 81675

Germany

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Regensburg, 93049

Germany

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Regensburg, 93053

Germany

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Tübingen, 72076

Germany

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Athens, 11526

Greece

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Athens, 11527

Greece

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Athens, 12462

Greece

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Athens, 18547

Greece

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Holargos, Athens, 155 62

Greece

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Thessaloniki, 55236

Greece

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Thessaloniki, 56 429

Greece

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Thessaloniki, 57001

Greece

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Hong Kong, 150001

Hong Kong

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Budapest, 1121

Hungary

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Budapest, 1122

Hungary

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Deszk, 6772

Hungary

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Győr, 9024

Hungary

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Salgótarján, 3100

Hungary

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Székesfehérvár, 8000

Hungary

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Törökbálint, 2045

Hungary

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Ahmedabad, 380054

India

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Bangalore, 560027

India

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Bangalore, 560064

India

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Delhi, 110085

India

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Gurgaon, 122001

India

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Howrah, 711103

India

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Hyderabad, 500032

India

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Jaipur, 302004

India

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Jaipur, 302022

India

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Kolkata, 700160

India

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Marg Jaipur, 302004

India

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Mohali, 160055

India

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Namakkal, 637001

India

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New Delhi, 110005

India

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New Delhi, 110029

India

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Varanasi, 221005

India

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Bergamo, 24127

Italy

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Roma, 00144

Italy

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Rozzano, 20089

Italy

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Udine, 33100

Italy

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Bunkyō City, 113-8431

Japan

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Bunkyō City, 113-8603

Japan

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Bunkyō City, 113-8677

Japan

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Chiba, 260-8717

Japan

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Fukuoka, 812-8582

Japan

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Hidaka-shi, 350-1298

Japan

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Hirosaki-shi, 036-8563

Japan

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Itabashi-ku, 173-0003

Japan

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Kashihara-shi, 634-8522

Japan

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Kōtoku, 135-8550

Japan

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Kumamoto, 860-8556

Japan

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Matsuyama, 791-0280

Japan

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Nagoya, 464-8681

Japan

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Osaka, 545-8586

Japan

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Osakasayama-shi, 589-8511

Japan

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Sapporo, 003-0804

Japan

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Sunto-gun, 411-8777

Japan

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Tokyo, 104-0045

Japan

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Yokohama, 221-0855

Japan

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Yokohama, 241-8515

Japan

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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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Aguascalientes, 20230

Mexico

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Chihuahua City, 31207

Mexico

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Guadalajara, 44280

Mexico

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Guadalajara, 44638

Mexico

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Mexico City, 03810

Mexico

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Monterrey, 64460

Mexico

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Oaxaca City, 68020

Mexico

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San Pedro Garza García, 66220

Mexico

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Sonora, 83207

Mexico

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Veracruz, 91900

Mexico

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Bodø, 8092

Norway

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Gjøvik, 2819

Norway

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Oslo, 0379

Norway

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Trondheim, 0730

Norway

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Bacolod, 6100

Philippines

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City of Muntinlupa, 1780

Philippines

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Iloilo City, 5000

Philippines

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Manila, 1000

Philippines

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Pasig, 1605

Philippines

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Quezon City, 1100

Philippines

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Quezon City, 1112

Philippines

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Bialystok, 15-027

Poland

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Gliwice, 44-102

Poland

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Gliwice, 44-102

Poland

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Katowice, 40-074

Poland

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Lodz, 93-513

Poland

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Warsaw, 02-781

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Wroclaw, 53-413

Poland

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Zielona Góra, 65-046

Poland

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Bucharest, 022328

Romania

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Bucharest, 050098

Romania

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Craiova, 200542

Romania

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Floreşti,

Romania

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Iași, 700483

Romania

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Oradea, 410001

Romania

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Sibiu, 550245

Romania

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Suceava, 720214

Romania

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Timișoara, 300166

Romania

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Cape Town, 7570

South Africa

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eManzimtoti, 4126

South Africa

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eManzimtoti, 4126

South Africa

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Johannesburg, 2196

South Africa

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Parktown, 2193

South Africa

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Pretoria, 0084

South Africa

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Daegu, 42415

South Korea

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Goyang-si, 10408

South Korea

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Incheon, 21431

South Korea

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Incheon, 21565

South Korea

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Jinju, 52727

South Korea

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Seoul, 02841

South Korea

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Seoul, 03722

South Korea

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Seoul, 06273

South Korea

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Seoul, 06351

South Korea

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Seoul, 07061

South Korea

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Suwon, 16247

South Korea

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Bilbao (Vizcaya), 48013

Spain

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Castellon, 12002

Spain

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Córdoba, 14004

Spain

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El Palmar, 30120

Spain

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Palma de Mallorca, 07010

Spain

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Sabadell (Barcelona), 08208

Spain

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Basel, 4031

Switzerland

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Bern, CH-3010

Switzerland

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Lausanne, 1011

Switzerland

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Hsinchu, 300

Taiwan

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New Taipei City, 220216

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, 10002

Taiwan

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Taipei, 10449

Taiwan

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Taipei, 11217

Taiwan

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Taoyuan, 333

Taiwan

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Bangkok, 10300

Thailand

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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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Adapazarı, 54290

Turkey (Türkiye)

Research Site

Ankara, 06340

Turkey (Türkiye)

Research Site

Ankara, 6100

Turkey (Türkiye)

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Antalya, 07058

Turkey (Türkiye)

Research Site

Çankaya, 06680

Turkey (Türkiye)

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Edirne, 22030

Turkey (Türkiye)

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Istanbul, 34098

Turkey (Türkiye)

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Istanbul, 34662

Turkey (Türkiye)

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Izmir, 35360

Turkey (Türkiye)

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Konya, 42080

Turkey (Türkiye)

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Birmingham, B9 5SS

United Kingdom

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Brighton, BN2 5BE

United Kingdom

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Cambridge, CB2 0QQ

United Kingdom

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Cardiff, CF14 2TL

United Kingdom

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Cheltenham, GL53 7AN

United Kingdom

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Edinburgh, EH4 2XR

United Kingdom

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High Heaton/Newcastle Upon Tyn, NE7 7DN

United Kingdom

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Leeds, LS 9 7TF

United Kingdom

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London, SE1 9RT

United Kingdom

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Nottingham, NG5 1PB

United Kingdom

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Truro, TR1 3LJ

United Kingdom

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Hanoi, 100000

Vietnam

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Hanoi, 10000

Vietnam

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Ho Chi Minh City, 700000

Vietnam