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A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer
Sponsor: AstraZeneca
Summary
The purpose of ARTEMIDE-Lung04 is to assess the efficacy and safety of rilvegostomig compared with pembrolizumab monotherapy as 1L treatment in participants with mNSCLC and whose tumors express PD-L1.
Official title: A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients With PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
830
Start Date
2025-04-10
Completion Date
2030-12-02
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
Rilvegostomig
Administered intravenously (IV) on Day 1 of each 21-day cycle
Pembrolizumab
Administered intravenously (IV) on Day 1 of each 21-day cycle
Locations (288)
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Newark, Delaware, United States
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Bay Pines, Florida, United States
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Clearwater, Florida, United States
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St. Petersburg, Florida, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Decatur, Illinois, United States
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Des Moines, Iowa, United States
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Waterloo, Iowa, United States
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Leawood, Kansas, United States
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Lexington, Kentucky, United States
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Owensboro, Kentucky, United States
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Bethesda, Maryland, United States
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Frederick, Maryland, United States
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Silver Spring, Maryland, United States
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Towson, Maryland, United States
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Bridgeton, Missouri, United States
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Lincoln, Nebraska, United States
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Paramus, New Jersey, United States
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Buffalo, New York, United States
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East Syracuse, New York, United States
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Fresh Meadows, New York, United States
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Westbury, New York, United States
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Canton, Ohio, United States
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Fountain Hill, Pennsylvania, United States
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Kittanning, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Round Rock, Texas, United States
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Aberdeen, Washington, United States
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Charleston, West Virginia, United States
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Morgantown, West Virginia, United States
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CABA, Argentina
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Córdoba, Argentina
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Pilar, Argentina
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Rosario, Argentina
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Rosario, Argentina
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Viedma, Argentina
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Hobart, Australia
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Woolloongabba, Australia
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Edegem, Belgium
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Jette, Belgium
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Libramont-Chevigny, Belgium
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Liège, Belgium
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Mechelen, Belgium
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Roeselaere, Belgium
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Blumenau, Brazil
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Fortaleza, Brazil
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Ijuí, Brazil
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Itajaí, Brazil
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Londrina, Brazil
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Passo Fundo, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Porto Velho, Brazil
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Salvador, Brazil
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Salvador, 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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Teresina, Brazil
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Burgas, Bulgaria
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Panagyurishte, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Edmonton, Alberta, Canada
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Kelowna, British Columbia, Canada
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Cambridge, Ontario, Canada
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Newmarket, Ontario, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Conception, Chile
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Santiago, Chile
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Santiago, Chile
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Santiago, Chile
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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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Bengbu, China
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Changchun, China
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Changchun, China
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Changsha, China
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Changsha, China
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Chengdu, China
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Chongqing, China
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Chongqing, China
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Fuzhou, China
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Fuzhou, China
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Guangzhou, China
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Haerbin, China
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Hangzhou, China
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Hefei, China
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Hefei, China
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Jiamusi, China
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Jinan, China
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Lanzhou, China
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Linyi, China
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Liuchow, China
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Nanchang, China
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Nanchang, China
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Nanjing, China
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Nanjing, China
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Nanning, China
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Ningbo, China
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Qingdao, China
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Shanghai, China
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Shenyang, China
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Suzhou, China
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Taiyuan, China
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Wuhan, China
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Wuhan, China
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Xuzhou, China
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Yantai, China
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Zhengzhou, China
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Cali, Colombia
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Floridablanca, Colombia
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Medellín, Colombia
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Valledupar, Colombia
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San José, Costa Rica
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San José, Costa Rica
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San José Capital, Costa Rica
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Santa Ana, Costa Rica
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Angers, France
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Avignon, France
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Boulogne-Billancourt, France
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Caen, France
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Chambéry, France
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Dijon, France
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La Tronche, France
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Limoges, France
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Nantes, France
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Paris, France
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Pau, France
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St-Malo, France
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Toulouse, France
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Amberg, Germany
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Augsburg, by, Germany
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Bad Saarow, Germany
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Berlin, Germany
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Berlin, Germany
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Bonn, Germany
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Braunschweig, Germany
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Essen, Germany
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Flensburg, Germany
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Frankfurt am Main, Germany
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Hamburg, Germany
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Heilbronn, Germany
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Immenhausen, Germany
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Koblenz, Germany
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Leipzig, Germany
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Mainz, Germany
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München, Germany
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Offenbach, Germany
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Oldenburg, Germany
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Rotenburg (Wümme), Germany
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Schweinfurt, Germany
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Trier, Germany
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Velbert, Germany
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Wuppertal, Germany
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Würselen, 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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Piraeus, Greece
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Thessaloniki, Greece
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Thessaloniki, Greece
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Thessaloniki, Greece
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Dublin, Ireland
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Dublin, Ireland
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Dublin, Ireland
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Dublin, Ireland
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Dublin, Ireland
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Galway, Ireland
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Afula, Israel
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Beersheba, Israel
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Hadera, 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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Ramat Gan, Israel
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Tel Aviv, Israel
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Tel Aviv, Israel
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Candiolo, Italy
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Lecco, Italy
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Lucca, Italy
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Meldola, Italy
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Milan, Italy
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Naples, Italy
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Peschiera del Garda, Italy
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Pisa, Italy
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Roma, Italy
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Torrette Di Ancona, Italy
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Udine, Italy
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Verona, Italy
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Akashi, Japan
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Bunkyō City, Japan
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Bunkyō City, Japan
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Fukuoka, Japan
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Fukuoka, Japan
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Hamamatsu, Japan
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Iwakuni-shi, Japan
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Izumi-shi, Japan
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Kashihara-shi, Japan
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Kobe, Japan
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Kōtoku, Japan
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Kurume-shi, Japan
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Kyoto, Japan
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Matsuyama, Japan
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Nankoku-shi, Japan
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Niigata, Japan
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Osaka, Japan
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Sakaishi, Japan
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Sayama, Japan
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Sendai, Japan
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Shinagawa-ku, Japan
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Takarazuka-shi, Japan
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Toon-Shi, Japan
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Toyoake-shi, Japan
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Toyonaka-shi, Japan
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George Town, Malaysia
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Kota Bharu, Malaysia
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Kuala Lumpur, Malaysia
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Kuala Selangor, Malaysia
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Perai, Malaysia
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Alcabideche, Portugal
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Braga, Portugal
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Coimbra, Portugal
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Lisbon, Portugal
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Lisbon, Portugal
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Lisbon, Portugal
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Loures, Portugal
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Matosinhos Municipality, Portugal
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Porto, Portugal
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Porto, Portugal
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Porto, Portugal
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Bucharest, Romania
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Bucharest, Romania
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Bucharest, Romania
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Bucharest, Romania
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Craiova, Romania
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Craiova, Romania
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Iași, Romania
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Otopeni, Romania
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Piteşti, Romania
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Sibiu, Romania
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Timișoara, Romania
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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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Badajoz, Spain
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Badalona, Spain
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Barcelona, Spain
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Castellon, Spain
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Granada, Spain
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Jaén, Spain
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Lugo, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, 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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Valencia, Spain
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Vigo (Pontevedra), Spain
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Zaragoza, Spain
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Lausanne, Switzerland
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Ankara, Turkey (Türkiye)
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Bakırköy, Turkey (Türkiye)
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Çankaya, Turkey (Türkiye)
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İzmit, Turkey (Türkiye)
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Küçükçekmece, Turkey (Türkiye)
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Yüreğir, Turkey (Türkiye)
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Blackpool, United Kingdom
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Glasgow, United Kingdom
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Guildford, United Kingdom
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Hull, United Kingdom
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Oxford, United Kingdom
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Stevenage, United Kingdom