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ACTIVE NOT RECRUITING
NCT02542293
PHASE3

Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)

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 versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.

Official title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy Versus Standard of Care Platinum-Based Chemotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC).

Key Details

Gender

All

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

953

Start Date

2015-11-03

Completion Date

2026-12-31

Last Updated

2026-02-12

Healthy Volunteers

No

Interventions

BIOLOGICAL

Durvalumab +Tremelimumab

DRUG

Paclitaxel + carboplatin

Chemotherapy Agents

DRUG

Gemcitabine + cisplatin

Chemotherapy Agents

DRUG

Gemcitabine + carboplatin

Chemotherapy Agents

DRUG

Pemetrexed + cisplatin

Chemotherapy Agent

DRUG

Pemetrexed + carboplatin

Chemotherapy Agent

Locations (210)

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Anaheim, California, United States

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San Diego, California, United States

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Santa Rosa, California, United States

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Louisville, Kentucky, United States

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Florham Park, New Jersey, United States

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Albuquerque, New Mexico, United States

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East Setauket, New York, United States

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Fresh Meadows, New York, United States

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Poughkeepsie, New York, United States

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Stony Brook, New York, United States

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Canton, Ohio, United States

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Columbus, Ohio, United States

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Zanesville, Ohio, United States

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Pittsburgh, Pennsylvania, United States

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Houston, Texas, United States

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Berazategui, Argentina

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CABA, Argentina

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Ciudad de Buenos Aires, Argentina

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Córdoba, Argentina

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La Rioja, Argentina

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Rosario, Argentina

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San Salvador de Jujuy, Argentina

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Santa Rosa, Argentina

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Barretos, Brazil

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Belo Horizonte, Brazil

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Belo Horizonte, Brazil

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Fortaleza, Brazil

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Ijuí, Brazil

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Itajaí, 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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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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São Paulo, Brazil

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Plovdiv, Bulgaria

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Shumen, 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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Vratsa, Bulgaria

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Santiago, Chile

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Santiago, Chile

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Santiago, Chile

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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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Changchun, China

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Chongqing, China

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Guangzhou, China

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Hangzhou, China

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Shanghai, China

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Shanghai, China

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Ürümqi, China

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Wuhan, China

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Wuhan, China

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Odense C, Denmark

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Oulu, Finland

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Tampere, Finland

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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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Holargos, Athens, Greece

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Ioannina, Greece

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Hong Kong, Hong Kong

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King's Park, Hong Kong

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Shatin, Hong Kong

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Ahmedabad, India

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Bangalore, India

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Bangalore, India

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Chennai, India

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Gūrgaon, India

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Karamsad, India

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New Delhi, India

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Beersheba, Israel

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Jerusalem, Israel

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Kfar Saba, Israel

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Nahariya, Israel

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Petah Tikva, Israel

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Ramat Gan, Israel

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Bunkyō City, Japan

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Fukushima, Japan

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Habikino-shi, Japan

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Hirosaki-shi, Japan

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Iizuka-shi, Japan

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Iwakuni-shi, Japan

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Kanazawa, Japan

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Kishiwada-shi, Japan

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Kobe, Japan

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Kurume-shi, Japan

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Kyoto, Japan

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Mitaka-shi, Japan

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Nagaoka-shi, Japan

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Nagoya, Japan

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Nagoya, Japan

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Niigata, Japan

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Okayama, Japan

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Osaka, Japan

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Saga, Japan

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Sagamihara-shi, Japan

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Sakaishi, Japan

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Sendai, Japan

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Tokushima, Japan

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Ube-shi, Japan

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Wakayama, Japan

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Yokohama, Japan

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Yokohama, Japan

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Kuala Lumpur, Malaysia

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Kuantan, Malaysia

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Kuching, Malaysia

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Acapulco, Mexico

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Aguascalientes, Mexico

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Mérida, Mexico

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México, Mexico

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México, Mexico

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Monterrey, Mexico

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Arequipa, Peru

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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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Lima, Peru

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Baguio City, Philippines

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Cebu, Philippines

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Las Piñas, Philippines

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Manila, Philippines

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Manila, Philippines

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Quezon City, Philippines

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Bydgoszcz, Poland

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Kielce, Poland

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Krakow, Poland

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Lodz, Poland

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Mrozy, Poland

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Olsztyn, Poland

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Poznan, Poland

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Warsaw, Poland

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Warsaw, Poland

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Wodzisław Śląski, Poland

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Amadora, Portugal

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Lisbon, Portugal

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Porto, Portugal

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Porto, Portugal

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Porto, Portugal

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Doha, Qatar

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Suceava, Romania

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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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Saint Petersburg, Russia

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Dammam, Saudi Arabia

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Riyadh, Saudi Arabia

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Riyadh, Saudi Arabia

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Singapore, Singapore

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Singapore, Singapore

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Singapore, Singapore

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Singapore, Singapore

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Daegu, South Korea

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Hwasun-gun, 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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Eskilstuna, Sweden

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Linköping, Sweden

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Stockholm, Sweden

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Uppsala, Sweden

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Adana, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Chernivtsі, Ukraine

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Dnipro, Ukraine

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Ivano-Frankivsk, Ukraine

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Kapitanivka Village, Ukraine

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Kharkiv Region, Ukraine

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Kirovohrad, Ukraine

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Kyiv, Ukraine

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Kyiv, Ukraine

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Liutizh, Ukraine

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Lviv, Ukraine

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Odesa, Ukraine

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Sumy, Ukraine

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Uzhhorod, Ukraine

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Vinnytsia, Ukraine

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Guildford, 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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Metropolitan Borough of Wirral, United Kingdom

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Nottingham, United Kingdom

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Taunton, United Kingdom

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Wolverhampton, United Kingdom