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ACTIVE NOT RECRUITING
NCT03164616
PHASE3

Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC) chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.

Official title: A Phase III, Randomized, Multi-Center, Open-Label, Comparative Global Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for First-Line Treatment in Patients With Metastatic Non Small-Cell Lung Cancer (NSCLC) (POSEIDON)

Key Details

Gender

All

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

1186

Start Date

2017-06-01

Completion Date

2027-11-15

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

Durvalumab

IV infusions every 3 weeks for 12 weeks (4 cycles) and every 4 weeks thereafter until disease progression or other discontinuation criteria

DRUG

Tremelimumab

IV infusions every 3 weeks for 12 weeks (4 cycles). An additional dose of tremelimumab will be administered in the week 16.

DRUG

Abraxane + carboplatin

Standard of care chemotherapy (squamous and non-squamous patients): Abraxane 100 mg/m2 on Days 1, 8, and 15 of each 21-day cycle. Carboplatin Area under the plasma drug concentration-time curve (AUC) 5 or 6 via IV infusion on Day 1 of each 21-day cycle for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3).

DRUG

Gemcitabine + cisplatin

Standard of care chemotherapy (squamous patients only): Gemcitabine 1000 or 1250 mg/m2 via IV infusion on Days 1 and 8 of each 21-day cycle + cisplatin 75 mg/m2 via IV infusion on Day 1 of each 21-day cycle, for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3).

DRUG

Gemcitabine + carboplatin

Standard of care chemotherapy (squamous patients only): Gemcitabine 1000 or 1250 mg/m2 via IV infusion on Days 1 and 8 of each 21-day cycle + carboplatin AUC 5 or 6 via IV infusion on Day 1 of each 21-day cycle for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3).

DRUG

Pemetrexed + carboplatin

Standard of care chemotherapy (non-squamous patients only): Pemetrexed 500 mg/m2 and carboplatin AUC 5 or 6 via IV infusion on Day 1 of each 21-day cycle for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3); then continue pemetrexed 500 mg/m2 maintenance \[i.e., q4w for Treatment Arms 1 and 2. For Treatment Arm 3, Pemetrexed maintenance therapy can be given either q3w or q4w (dependent on Investigator decision and local standards)\] until objective disease progression.

DRUG

Pemetrexed + cisplatin

Standard of care chemotherapy (non-squamous patients only): Pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 via IV infusion on Day 1 of each 21-day cycle, for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3); then continue pemetrexed 500 mg/m2 maintenance \[i.e., q4w for Treatment Arms 1 and 2. For Treatment Arm 3, Pemetrexed maintenance therapy can be given either q3w or q4w (dependent on Investigator decision and local standards)\] until objective disease progression.

Locations (175)

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Phoenix, Arizona, United States

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Bakersfield, California, United States

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Santa Monica, California, 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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Louisville, Kentucky, United States

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Kansas City, Missouri, United States

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Canton, Ohio, 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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Fort Worth, Texas, United States

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Houston, Texas, United States

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Richmond, Virginia, United States

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Barretos, Brazil

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Belo Horizonte, Brazil

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Curitiba, 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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Ribeirão Preto, Brazil

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Rio de Janeiro, Brazil

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Santo André, 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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São Paulo, Brazil

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São Paulo, Brazil

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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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Changchun, China

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Changsha, China

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Fuzhou, China

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Guangzhou, China

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Hangzhou, China

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Harbin, China

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Hefei, China

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Kunming, China

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Linyi, China

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Liuchow, China

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Nanjing, China

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Qingdao, 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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Wuhan, China

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Wuhan, China

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Xining, China

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Yangzhou, China

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Zhanjiang, China

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Zhengzhou, China

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Zhengzhou, China

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Berlin, Germany

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Essen, Germany

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Freiburg im Breisgau, Germany

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Gauting, Germany

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Hamburg, Germany

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Hamburg, Germany

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Heidelberg, Germany

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Immenhausen, Germany

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Mainz, Germany

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Oldenburg, Germany

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Würzburg, Germany

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Shatin, Hong Kong

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Budapest, Hungary

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Budapest, Hungary

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Kecskemét, Hungary

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Miskolc, Hungary

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Törökbálint, Hungary

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Bunkyō City, Japan

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Chūōku, Japan

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Fukuoka, Japan

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Hiroshima, Japan

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Iwakuni-shi, Japan

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Kanazawa, Japan

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Kashiwa, Japan

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Kōtoku, Japan

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Kurume-shi, Japan

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Matsuyama, Japan

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Okayama, Japan

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Okayama, Japan

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Sapporo, Japan

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Sayama, Japan

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Sunto-gun, Japan

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Toyoake-shi, Japan

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Ube-shi, Japan

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Yokohama, Japan

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Yokohama, Japan

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Aguascalientes, Mexico

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Cuautitlán Izcalli, Mexico

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Guadalajara, Mexico

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Mexico City, 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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Tuxtla Gutiérrez, Mexico

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Arequipa, 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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San Isidro, Peru

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Olsztyn, Poland

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Tomaszów Mazowiecki, Poland

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Warsaw, Poland

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Wodzisław Śląski, Poland

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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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Omsk, 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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Cape Town, South Africa

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Durban, South Africa

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Johannesburg, South Africa

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Parktown, South Africa

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Pretoria, South Africa

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Rondebosch, South Africa

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Vereeniging, South Africa

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Busan, South Korea

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Chungcheongbuk-do, South Korea

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Daegu, South Korea

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Incheon, 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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Seoul, South Korea

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Seoul, South Korea

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Ulsan, South Korea

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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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Taipei, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyuan District, Taiwan

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Bangkok, Thailand

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Bangkok, Thailand

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Bangkok, Thailand

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Muang, Thailand

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Songkhla, Thailand

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Dnipro, Ukraine

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Ivano-Frankivsk, Ukraine

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Kirovohrad, 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

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Leicester, United Kingdom

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London, 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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Hanoi, Vietnam

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Ho Chi Minh City, Vietnam