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ACTIVE NOT RECRUITING
NCT05687266
PHASE3

Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).

Official title: A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (D926NC00001; AVANZAR)

Key Details

Gender

All

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

1350

Start Date

2022-12-29

Completion Date

2027-11-01

Last Updated

2026-03-13

Healthy Volunteers

No

Conditions

Interventions

DRUG

Datopotamab deruxtecan

Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

DRUG

Durvalumab

Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

DRUG

Carboplatin

Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.

DRUG

Pembrolizumab

Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle for a maximum of 35 cycles or 2 years (whichever occurs first).

DRUG

Cisplatin

Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.

DRUG

Pemetrexed

Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

DRUG

Paclitaxel

Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.

Locations (254)

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Hot Springs, Arkansas, United States

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Little Rock, Arkansas, United States

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Springdale, Arkansas, United States

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Fountain Valley, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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Boulder, Colorado, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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St. Petersburg, Florida, United States

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West Palm Beach, Florida, United States

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Hinsdale, Illinois, United States

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Fort Wayne, Indiana, United States

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Bettendorf, Iowa, United States

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Iowa City, Iowa, United States

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Waukee, Iowa, United States

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Baton Rouge, Louisiana, United States

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Covington, Louisiana, United States

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Duluth, Minnesota, United States

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Rochester, Minnesota, United States

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Hannibal, Missouri, United States

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Lincoln, Nebraska, United States

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Lincoln, Nebraska, United States

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Clifton Park, New York, United States

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Asheville, North Carolina, United States

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Canton, Ohio, United States

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Columbus, Ohio, United States

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Maumee, Ohio, United States

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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Salem, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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York, Pennsylvania, United States

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Watertown, South Dakota, United States

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Memphis, Tennessee, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Fairfax, Virginia, United States

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Henrico, Virginia, United States

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Norfolk, Virginia, United States

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Renton, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Appleton, Wisconsin, United States

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La Crosse, Wisconsin, United States

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Graz, Austria

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Rankweil, Austria

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Vienna, Austria

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Vienna, Austria

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Blumenau, Brazil

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Florianópolis, Brazil

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Fortaleza, Brazil

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Londrina, Brazil

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Porto Alegre, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Taubaté, Brazil

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Vitória, Brazil

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Sofia, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Saint John, New Brunswick, Canada

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Brampton, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Kitchener, Ontario, Canada

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Newmarket, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Saint-Jérôme, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Beijing, China

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Beijing, China

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Beijing, China

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Beijing, China

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Beijing, China

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Beijing, China

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Changsha, China

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Changsha, China

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Chengdu, China

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Chengdu, China

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Chongqing, China

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Guangzhou, China

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Guangzhou, China

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Hefei, China

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Jinan, China

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Kunming, China

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Lanzhou, China

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Liuchow, China

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Shandong, China

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Shanghai, China

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Shanghai, China

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Shanghai, China

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Shantou, China

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Shenyang, China

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Shenzhen, China

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Taiyuan, China

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Tianjin, China

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Wenzhou, China

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Wuhan, China

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Wuhan, China

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Xiamen, China

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Yangzhou, China

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Zhengzhou, China

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Brest, France

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Créteil, France

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Gleizé, France

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Montpellier, France

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Nîmes, France

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Paris, France

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Paris, France

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Rouen, France

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Saint-Quentin, France

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Strasbourg, France

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Toulon, France

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Toulouse, France

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Tours, France

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Bad Berka, Germany

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Berlin, Germany

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Frankfurt A. Main, Germany

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Gauting, Germany

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Gütersloh, Germany

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Hamburg, Germany

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Kassel, Germany

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Kiel, Germany

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Koblenz, Germany

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Minden, Germany

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Rosenheim, Germany

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Velbert, Germany

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Würzburg, Germany

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Athens, Greece

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Athens, Greece

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Athens, Greece

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Piraeus, Greece

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Thessaloniki, Greece

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Thessaloniki, Greece

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Budapest, Hungary

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Budapest, Hungary

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Gyöngyös - Mátraháza, Hungary

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Kaposvár, Hungary

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Pécs, Hungary

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Szekszárd, Hungary

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Szolnok, Hungary

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Törökbálint, Hungary

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Calicut, India

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Delhi, India

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Delhi, India

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Jaipur, India

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Kolkata, India

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Madurai, India

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Puducherry, India

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Florence, Italy

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Lecco, Italy

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Messina, Italy

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Naples, Italy

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Orbassano, Italy

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Padova, Italy

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Parma, Italy

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Peschiera del Garda, Italy

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Rozzano, Italy

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Bunkyō City, Japan

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Chūōku, Japan

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Hamamatsu, Japan

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Hamamatsu, Japan

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Hidaka-shi, Japan

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Hirosaki-shi, Japan

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Hiroshima, Japan

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Kumamoto, Japan

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Nagoya, Japan

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Nagoya, Japan

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Okayama, Japan

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Osaka, Japan

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Osakasayama-shi, Japan

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Sapporo, Japan

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Sunto-gun, Japan

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Wakayama, Japan

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Yokohama, Japan

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Yokohama, Japan

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Del. Cuauhtemoc, Mexico

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Mexico City, Mexico

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México, Mexico

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San Luis Potosí City, Mexico

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Arequipa, Peru

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Concepción, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Bydgoszcz, Poland

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Bystra, Poland

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Grudziądz, Poland

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Kielce, Poland

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Koszalin, Poland

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Olsztyn, Poland

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Poznan, Poland

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Przemyśl, Poland

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Racibórz, Poland

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Radom, Poland

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Siedlce, Poland

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Busan, South Korea

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Cheongju-si, South Korea

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Jinju, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Suwon, South Korea

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Suwon, South Korea

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Las Palmas de Gran Canaria, Spain

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Lugo, Spain

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Madrid, Spain

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Santander, Spain

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Seville, Spain

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Valencia, Spain

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Zaragoza, Spain

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Gävle, Sweden

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Linköping, Sweden

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Lund, Sweden

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Stockholm, Sweden

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Uppsala, Sweden

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Hsinchu, Taiwan

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New Taipei City, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taoyuan District, Taiwan

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Adana, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Edirne, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Aberdeen, United Kingdom

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Cambridge, United Kingdom

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Cardiff, United Kingdom

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Cheltenham, United Kingdom

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Edinburgh, United Kingdom

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London, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Middlesbrough, United Kingdom

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Newcastle upon Tyne, United Kingdom

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Taunton, United Kingdom

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Hanoi, Vietnam

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Ho Chi Minh City, Vietnam