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Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)
Sponsor: AstraZeneca
Summary
This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy 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 locally advanced or metastatic NSCLC
Official title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC)(MYSTIC).
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
1118
Start Date
2015-07-21
Completion Date
2026-12-31
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
MEDI4736 (Durvalumab)
MEDI4736 (Durvalumab)+Tremelimumab
Paclitaxel + Carboplatin
Chemotherapy Agents
Gemcitabine + Cisplatin
Chemotherapy Agents
Gemcitabine + Carboplatin
Chemotherapy Agents
Pemetrexed + Cisplatin
Chemotherapy Agents
Pemetrexed + Carboplatin
Chemotherapy Agents
Tremelimumab
Locations (196)
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Yuma, Arizona, United States
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Bakersfield, California, United States
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Fullerton, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Redondo Beach, California, United States
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Sacramento, California, United States
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San Luis Obispo, California, United States
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Santa Maria, California, United States
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West Hollywood, California, United States
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New Haven, Connecticut, United States
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Jacksonville, Florida, United States
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Pembroke Pines, Florida, United States
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Tampa, Florida, United States
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Athens, Georgia, United States
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Honolulu, Hawaii, United States
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Baltimore, Maryland, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Summit, New Jersey, United States
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Mineola, New York, 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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New York, New York, United States
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Charlotte, North Carolina, United States
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Cleveland, Ohio, United States
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North Charleston, South Carolina, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Richmond, Virginia, United States
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Madison, Wisconsin, United States
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Box Hill, Australia
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Gosford, Australia
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Kogarah, Australia
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Melbourne, Australia
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Port Macquarie, Australia
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Southport, Australia
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St Leonards, Australia
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Brussels, Belgium
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Charleroi, Belgium
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Duffel, Belgium
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Leuven, Belgium
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Liège, Belgium
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Greater Sudbury, Ontario, Canada
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Kingston, Ontario, Canada
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Newmarket, Ontario, Canada
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Oshawa, Ontario, Canada
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Saint Catherines, Ontario, Canada
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Sault Ste. Marie, Ontario, Canada
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Toronto, Ontario, Canada
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Regina, Saskatchewan, Canada
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Saskatoon, Saskatchewan, Canada
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Bordeaux, France
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Brest, France
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Créteil, France
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Lille, France
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Lyon, France
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Marseille, France
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Aachen, Germany
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Bad Berka, Germany
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Berlin, Germany
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Berlin, 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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Heidelberg, Germany
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Hemer, Germany
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Homburg/Saar, Germany
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Immenhausen, Germany
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Löwenstein, Germany
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Lübeck, Germany
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Mainz, Germany
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Münster, Germany
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Oldenburg, Germany
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Ulm, Germany
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Velbert, Germany
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Würzburg, Germany
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Budapest, Hungary
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Deszk, Hungary
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Edelény, Hungary
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Kaposvár, Hungary
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Kecskemét, Hungary
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Miskolc, Hungary
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Nyíregyháza, Hungary
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Pécs, Hungary
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Székesfehérvár, Hungary
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Genova, Italy
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Meldola, Italy
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Milan, Italy
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Milan, Italy
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Milan, Italy
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San Giovanni Rotondo, Italy
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Siena, Italy
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Fukushima, Japan
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Himeji-shi, Japan
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Hirakata-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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Izumi-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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Koga-shi, Japan
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Kyoto, 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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Okayama, Japan
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Osaka, Japan
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Osaka, Japan
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Saga, Japan
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Saitama-shi, Japan
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Sakaishi, Japan
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Sayama, Japan
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Sendai, Japan
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Shinjuku-ku, 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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Yokosuka-shi, Japan
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's-Hertogenbosch, Netherlands
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Amsterdam, Netherlands
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Arnhem, Netherlands
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Breda, Netherlands
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Groningen, Netherlands
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Maastricht, Netherlands
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Rotterdam, Netherlands
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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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Moscow, Russia
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Obninsk, 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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Busan, South Korea
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Changwon-si, South Korea
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Cheongju-si, South Korea
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Daegu, South Korea
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Daegu, South Korea
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Daejeon, South Korea
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Goyang-si, 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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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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Suwon, South Korea
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Ulsan, South Korea
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A Coruña, Spain
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Alicante, Spain
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Barcelona, Spain
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Barcelona, Spain
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Girona, Spain
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Jaén, Spain
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León, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Majadahonda, Spain
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Málaga, Spain
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Seville, Spain
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Seville, Spain
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Valencia, Spain
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Bellinzona, Switzerland
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Lausanne, Switzerland
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Kaohsiung City, Taiwan
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Kaohsiung City, 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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Taoyuan District, Taiwan
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Bangkok, Thailand
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Chiang Mai, Thailand
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Hat Yai, Thailand
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Khon Kaen, Thailand
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Hanoi, Vietnam
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam