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A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Sponsor: AstraZeneca
Summary
This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).
Official title: A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants With EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Has Progressed on Prior Osimertinib Treatment (TROPION-Lung15)
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
744
Start Date
2024-10-04
Completion Date
2028-09-27
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
Dato-DXd
Dato-DXd will be administered as IV infusion.
Osimertinib
Osimertinib will be administered orally.
Pemetrexed
Pemetrexed will be administered as IV infusion.
Carboplatin
Carboplatin will be administered as IV infusion.
Cisplatin
Cisplatin will be administered as IV infusion.
Locations (302)
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Fayetteville, Arkansas, United States
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Duarte, California, United States
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Fountain Valley, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Colorado Springs, Colorado, United States
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Fort Collins, Colorado, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Athens, Georgia, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Kansas City, Missouri, United States
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Omaha, Nebraska, United States
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Morristown, New Jersey, United States
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Northfield, New Jersey, United States
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New York, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Maumee, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Fairfax, Virginia, United States
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Seattle, Washington, United States
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Fitzroy, Australia
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Heidelberg, Australia
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Kogarah, Australia
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Liverpool, Australia
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Nedlands, Australia
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Port Macquarie, Australia
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St Leonards, Australia
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Westmead, Australia
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Woodville, Australia
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Woolloongabba, Australia
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Charleroi, Belgium
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Edegem, Belgium
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Ghent, Belgium
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Hasselt, Belgium
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Jette, Belgium
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La Louvière, Belgium
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Leuven, Belgium
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Namur, Belgium
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Roeselare, Belgium
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Barretos, Brazil
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Betim, Brazil
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Blumenau, Brazil
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Florianópolis, Brazil
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Itajaí, Brazil
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Pelotas, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Rio de Janeiro, Brazil
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Brampton, Ontario, Canada
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Newmarket, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Baoding, 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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Beijing, China
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Beijing, China
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Bengbu, China
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Changchun, China
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Changchun, China
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Changsha, China
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Chengdu, China
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Deyang, China
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Ganzhou, China
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Guangzhou, China
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Hangzhou, China
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Hangzhou, China
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Hefei, China
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Hengyang, China
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Huaian, China
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Jinan, China
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Linyi, China
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Luoyang, China
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Luzhou, China
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Nanchang, China
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Nanjing, China
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Shanghai, China
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Shantou, China
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Shenyang, China
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Shenyang, China
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Tianjin, China
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Tianjin, China
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Weifang, China
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Wuhan, China
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Zhengzhou, China
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Zhengzhou, China
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Zhengzhou, China
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Angers, France
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Avignon, France
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Bordeaux, France
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Caen, France
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Lille, France
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Montpellier, France
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Nantes, France
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Paris, France
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Paris, France
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Pessac, France
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Quimper, France
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Toulon Armees, France
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Toulouse, France
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Tours, France
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Villejuif, France
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Berlin, Germany
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Berlin-Zehlendorf, Germany
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Bonn, Germany
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Essen, Germany
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Georgsmarienhütte, Germany
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Giessen, Germany
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Großhansdorf, Germany
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Hamburg, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Kempten, Germany
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Löwenstein, Germany
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Nuremberg, Germany
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Oldenburg, Germany
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Athens, Greece
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Athens, Greece
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Athens, Greece
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Athens, Greece
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Heraklion, Greece
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Thessaloniki, Greece
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Thessaloniki, Greece
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Thessaloniki, Greece
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Thessaloniki, Greece
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Hong Kong, Hong Kong
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Hong Kong, Hong Kong
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Hong Kong, Hong Kong
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Hong Kong, Hong Kong
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Shatin, Hong Kong
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Amravati, India
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Bhubaneswar, India
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Hyderabad, India
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Kolhāpur, India
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Mumbai, India
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Mysuru, India
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Namakkal, India
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Pune, India
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Raipur, India
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Rajasthan, India
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Ranchi, India
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Thane, India
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Trivandrum, India
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Varanasi, India
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Beersheba, Israel
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Haifa, Israel
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Haifa, Israel
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Jerusalem, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Petah Tikva, Israel
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Ramat Gan, Israel
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Tel Aviv, Israel
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Bari, Italy
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Milan, Italy
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Misterbianco, Italy
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Monza, Italy
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Naples, Italy
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Padova, Italy
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Parma, Italy
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Perugia, Italy
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Roma, Italy
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Rozzano, Italy
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Verona, Italy
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Bunkyō City, Japan
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Fukuoka, Japan
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Hiroshima, Japan
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Iruma-Gun, Japan
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Kobe, Japan
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Kyoto, Japan
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Matsuyama, Japan
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Nagoya, Japan
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Nagoya, Japan
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Niigata, Japan
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Osaka, Japan
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Osaka, Japan
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Ōsaka-sayama, Japan
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Sendai, Japan
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Sunto-gun, Japan
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Toyoake-shi, Japan
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Utsunomiya, Japan
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Wakayama, Japan
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Yokohama, Japan
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Yokohama, Japan
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Alor Star, Malaysia
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Cheras, Malaysia
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Johor Bahru, Malaysia
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Kuala Lumpur, Malaysia
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Kuala Selangor, Malaysia
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Kuching, Malaysia
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Perai, Malaysia
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Petaling Jaya, Malaysia
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Amersfoort, Netherlands
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Harderwijk, Netherlands
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Rotterdam, Netherlands
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Zutphen, Netherlands
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Bacolod, Philippines
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Cebu City, Philippines
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Davao City, Philippines
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Manila, Philippines
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Quezon, Philippines
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Quezon, Philippines
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San Juan City, Philippines
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Katowice, Poland
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Krakow, Poland
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Lodz, Poland
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Olsztyn, Poland
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Poznan, Poland
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Braga, Portugal
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Loures, Portugal
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Porto, Portugal
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Craiova, Romania
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Craiova, Romania
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Singapore, Singapore
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Singapore, Singapore
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Singapore, Singapore
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Busan, South Korea
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Goyang-si, South Korea
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Gyeonggi-do, 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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A Coruña, Spain
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Barakaldo, Spain
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Barcelona, Spain
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Barcelona, Spain
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El Palmar, Spain
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L'Hospitalet de Llobregat, Spain
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Madrid, Spain
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Madrid, Spain
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Majadahonda, Spain
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Málaga, Spain
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Oviedo, Spain
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Palma de Mallorca, Spain
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Pamplona, Spain
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Santander, Spain
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Santiago de Compostela-Coruña, Spain
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Seville, Spain
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Valencia, Spain
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Valencia, Spain
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Valladolid, Spain
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Changhua, Taiwan
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Kaohsiung City, Taiwan
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New Taipei City, Taiwan
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Taichung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Bangkok, Thailand
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Bangkok, Thailand
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Bangkok, Thailand
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Chiang Mai, Thailand
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Hat Yai, Thailand
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Khon Kaen, Thailand
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Pathum Thani, Thailand
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Birmingham, United Kingdom
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Glasgow, United Kingdom
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Leicester, United Kingdom
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London, United Kingdom
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Middlesbrough, United Kingdom
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Hanoi, Vietnam