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A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer
Sponsor: AstraZeneca
Summary
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.
Official title: A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)
Key Details
Gender
All
Age Range
18 Years - 120 Years
Study Type
INTERVENTIONAL
Enrollment
825
Start Date
2018-12-06
Completion Date
2028-09-11
Last Updated
2025-06-11
Healthy Volunteers
No
Conditions
Interventions
Durvalumab
1500mg on Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and 1500mg on Day 1 of each 4-week cycle for 12 cycles during the adjuvant period
Placebo
Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and Day 1 of each 4-week cycle for 12 cycles during the adjuvant period
Carboplatin
Area under the curve of 5/6 on Day 1 of each 3-week cycle for 4 cycles
Cisplatin
75 mg/m2 on Day 1 of each 3-week cycle, for 4 cycles
Pemetrexed
500 mg/m2 on Day 1 of each 3-week cycle for 4 cycles.
Paclitaxel
200mg/m2 on Day 1 of each 3-week cycle for 4 cycles.
Gemcitabine
1250 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for 4 cycles.
Surgery
Expected within 40 days from the last dose of Investigational Product following the completion of neoadjuvant treatment.
Locations (231)
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Phoenix, Arizona, United States
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Duarte, California, United States
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Orange, California, United States
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Aurora, Colorado, United States
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Boca Raton, Florida, United States
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Jacksonville, Florida, United States
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Chicago, Illinois, United States
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Wichita, Kansas, United States
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Ashland, Kentucky, United States
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Lexington, Kentucky, United States
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Silver Spring, Maryland, United States
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Towson, Maryland, United States
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Duluth, Minnesota, United States
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Minneapolis, Minnesota, United States
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Morristown, 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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Shirley, New York, United States
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Durham, North Carolina, United States
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Bend, Oregon, United States
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Medford, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Charleston, South Carolina, United States
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Austin, 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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Fairfax, Virginia, United States
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Kirkland, Washington, United States
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Seattle, Washington, United States
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Buenos Aires, Argentina
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CABA, Argentina
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CABA, Argentina
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La Plata, Argentina
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Pergamino, Argentina
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Rosario, Argentina
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San Salvador de Jujuy, Argentina
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Viedma, Argentina
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Graz, Austria
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Innsbruck, Austria
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Rankweil, Austria
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Vienna, Austria
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Vienna, Austria
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Ghent, Belgium
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Liège, Belgium
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Mons, Belgium
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Barretos, Brazil
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Belo Horizonte, Brazil
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Campinas, Brazil
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Curitiba, Brazil
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Florianópolis, Brazil
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Natal, Brazil
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Porto Alegre, Brazil
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Santa Maria, Brazil
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São José do Rio Preto, 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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Vitória, Brazil
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Edmonton, Alberta, Canada
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Kitchener, Ontario, Canada
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Lévis, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Santiago, Chile
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Santiago, Chile
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Temuco, Chile
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Viña del Mar, Chile
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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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Changzhou, China
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Chengdu, China
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Guangzhou, China
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Guangzhou, China
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Guiyang, China
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Hangzhou, China
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Hangzhou, China
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Hangzhou, China
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Hangzhou, China
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Hefei, China
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Kunming, China
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Linhai, China
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Nanchang, China
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Ningbo, China
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Shanghai, China
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Shanghai, China
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Shenyang, China
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Shenyang, China
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Shenzhen, China
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Shenzhen, China
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Tianjin, China
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Ürümqi, China
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Wuhan, China
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Wuhan, China
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Xiamen, China
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Xintai, China
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Yangzhou, China
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Zhengzhou, China
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San José, Costa Rica
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San José, Costa Rica
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Avignon, France
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Lyon, France
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Nice, France
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Toulon, France
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Vantoux, France
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Bielefeld, Germany
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Cologne, Germany
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Frankfurt am Main, Germany
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Immenstadt im Allgäu, Germany
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Budapest, Hungary
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Gyöngyös - Mátraháza, Hungary
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Győr, Hungary
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Székesfehérvár, Hungary
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Törökbálint, Hungary
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Ahmedabad, India
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Gūrgaon, India
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Gūrgaon, India
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Kolkata, India
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Manipal, India
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Mumbai, India
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Mumbai, India
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Mysuru, India
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Namakkal, India
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Nashik, India
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New Delhi, India
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New Delhi, India
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Thane, India
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Visakhapatnam, India
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Ancona, Italy
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Bari, Italy
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Bergamo, Italy
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Florence, Italy
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Milan, Italy
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Monza, Italy
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Padova, Italy
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Roma, Italy
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Verona, Italy
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Habikino-shi, Japan
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Himeji-shi, Japan
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Hiroshima, Japan
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Hiroshima, Japan
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Iwakuni-shi, Japan
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Kitaadachi-gun, Japan
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Kitakyushu-shi, Japan
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Kurashiki Shi, Japan
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Nagoya, Japan
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Niigata, Japan
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Okayama, Japan
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Osakasayama-shi, Japan
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Toyoake-shi, Japan
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Wakayama, Japan
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Aguascalientes, Mexico
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Chihuahua City, Mexico
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Guadalajara, Mexico
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México, Mexico
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México, Mexico
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Monterrey, Mexico
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Monterrey, Mexico
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Pachuca, Mexico
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Arnhem, Netherlands
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Nijmegen, Netherlands
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Bellavista, 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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Davao City, Philippines
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Iloilo City, Philippines
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Makati, Philippines
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Quezon City, Philippines
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Bialystok, Poland
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Olsztyn, Poland
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Warsaw, Poland
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Warsaw, Poland
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Suceava, Romania
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Kazan', Russia
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Krasnoyarsk, Russia
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Moscow, Russia
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Moscow, Russia
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Moscow, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Obninsk, Russia
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Tomsk, Russia
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Yaroslavl, Russia
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Busan, South Korea
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Cheongju-si, South Korea
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Seongnam-si, 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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Alicante, Spain
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Barcelona, Spain
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Donostia / San Sebastian, Spain
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Madrid, Spain
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Málaga, Spain
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Oviedo, Spain
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Pamplona, Spain
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Santiago de Compostela (A Coruña), Spain
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Changhua, 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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Chiang Mai, Thailand
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Chiang Rai, Thailand
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Khon Kaen, Thailand
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Lampang, Thailand
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam