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Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)
Sponsor: AstraZeneca
Summary
This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line treatment in patients with extensive-stage small-cell lung cancer
Official title: A Phase III, Randomized, Multicenter,Open-Label, Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients With Extensive Disease Small-Cell Lung Cancer (SCLC) (CASPIAN)
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
987
Start Date
2017-03-27
Completion Date
2025-12-31
Last Updated
2025-10-21
Healthy Volunteers
No
Interventions
Durvalumab
IV infusions every 3 weeks for 12 weeks (4 cycles) and every 4 weeks thereafter until PD or other discontinuation criteria.
Tremelimumab
IV infusions every 3 weeks for 12 weeks(4 cycles). An additional dose of tremelimumab will be administered in the week 16.
Carboplatin
up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3
Cisplatin
up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3
Etoposide
up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3
Locations (207)
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Birmingham, Alabama, United States
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Scottsdale, Arizona, United States
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Rogers, Arkansas, United States
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Santa Monica, California, United States
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New Haven, Connecticut, United States
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Athens, Georgia, United States
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Fort Wayne, Indiana, United States
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Muncie, Indiana, United States
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Leawood, Kansas, United States
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Wichita, Kansas, United States
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Paducah, Kentucky, United States
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Grand Rapids, Michigan, United States
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Mineola, New York, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Harrisburg, Pennsylvania, United States
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Sioux Falls, South Dakota, United States
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Nashville, Tennessee, United States
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Kennewick, Washington, United States
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Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Mar del Plata, Argentina
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Rosario, Argentina
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San Miguel de Tucumán, Argentina
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Linz, Austria
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Salzburg, Austria
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Vienna, Austria
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Vienna, Austria
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Barretos, Brazil
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Curitiba, Brazil
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Passo Fundo, Brazil
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Porto Alegre, Brazil
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Ribeirão Preto, Brazil
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Rio de Janeiro, Brazil
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Salvador, Brazil
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Santo André, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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Panagyurishte, Bulgaria
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Plovdiv, Bulgaria
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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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Sofia, Bulgaria
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Varna, Bulgaria
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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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Changsha, China
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Chengdu, China
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Chongqing, 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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Nanchang, China
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Nanjing, China
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Nanjing, China
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Shanghai, China
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Shanghai, China
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Shenyang, China
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Ürümqi, China
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Wenzhou, China
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Wuhan, China
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Wuhan, China
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Xi'an, China
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Xi'an, China
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Zhanjiang, China
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Zhengzhou, China
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Zhuhai, China
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Brno, Czechia
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Olomouc, Czechia
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Ostrava - Vitkovice, Czechia
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Prague, Czechia
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Prague, Czechia
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Prague, Czechia
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Avignon, France
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Brest, France
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Créteil, France
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La Tronche, France
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Pierre-Bénite, France
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Rennes, France
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Aachen, Germany
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Berlin, Germany
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Gauting, Germany
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Gera, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Mainz, Germany
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Regensburg, Germany
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Budapest, Hungary
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Budapest, Hungary
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Budapest, Hungary
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Budapest, Hungary
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Deszk, Hungary
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Gyula, Hungary
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Kaposvár, Hungary
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Kecskemét, Hungary
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Miskolc, Hungary
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Pécs, Hungary
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Székesfehérvár, Hungary
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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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Bergamo, Italy
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Meldola, Italy
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Milan, Italy
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Palermo, Italy
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Roma, Italy
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Terni, Italy
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Chūōku, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Himeji-shi, Japan
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Iwakuni-shi, Japan
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Kashiwa, 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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Nagoya, Japan
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Nagoya, Japan
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Okayama, Japan
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Sakaishi, Japan
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Sayama, Japan
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Tokushima, Japan
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Ube-shi, Japan
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Yokohama, Japan
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Yokohama, Japan
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Amsterdam, Netherlands
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Arnhem, Netherlands
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Groningen, Netherlands
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Hengelo, Netherlands
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Maastricht, Netherlands
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Rotterdam, Netherlands
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Bialystok, Poland
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Bialystok, Poland
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Lublin, Poland
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Olsztyn, Poland
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Warsaw, Poland
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Cluj-Napoca, Romania
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Floreşti, Romania
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Suceava, Romania
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Moscow, Russia
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Omsk, Russia
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Ufa, Russia
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Banská Bystrica, Slovakia
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Bardejov, Slovakia
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Bratislava, Slovakia
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Bratislava, Slovakia
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Košice, Slovakia
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Nové Zámky, Slovakia
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Trnava, Slovakia
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Changwon, South Korea
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Cheongju-si, South Korea
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Daegu, South Korea
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Incheon, South Korea
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Jinju, South Korea
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Seongnam-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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A Coruña, Spain
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Badajoz, Spain
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Badalona, Spain
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Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Santander, Spain
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Valencia, Spain
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Zaragoza, Spain
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Changhua, Taiwan
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Kaohsiung City, Taiwan
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Kaohsiung 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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Ankara, 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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Izmir, Turkey (Türkiye)
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Dnipro, Ukraine
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Ivano-Frankivsk, Ukraine
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Kirovohrad, Ukraine
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Kryvyi Rih, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Sumy, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhia, Ukraine