New hope for lung cancer patients whose current drug stops working
NCT ID NCT05261399
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This study tests whether adding savolitinib to osimertinib works better than chemotherapy for people with a certain type of advanced lung cancer (EGFR-mutated, MET-positive) that has stopped responding to osimertinib. About 345 adults will be randomly assigned to receive either the drug combo or chemotherapy. The main goal is to see how long the cancer stays under control.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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341 people
The number who actually took part.
- Started
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Aug 2022
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 130 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Provision of signed and dated written ICF prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses. * Participant must be ≥18 years (≥ 19 years of age in South Korea) at the time of signing the informed consent. All genders are permitted. * Histologically or cytologically confirmed locally advanced or metastatic NSCLC which is not amenable to curative therapy. * Must have at least one documented sensitising EGFR mutation: exon19 deletion, L858R mutation, and/or T790M. * Documented radiologic progression on first- or second-line treatment with osimertinib as the most recent anti-cancer therapy. * Mandatory provision of FFPE tumour tissue. * MET overexpression and/or amplification in tumour specimen collected following progression on prior osimertinib treatment. * Measurable disease as defined by RECIST 1.1. * Adequate haematological, liver, renal and cardiac functions, and coagulation parameters. * ECOG performance status of 0 or 1. Exclusion Criteria: * Predominant squamous NSCLC, and small cell lung cancer. * Prior or current treatment with a third-generation EGFR-TKI other than Osimertinib. * Prior or current treatment with savolitinib or another MET inhibitors. * Spinal cord compression or brain metastases, unless asymptomatic and are stable. * History or active leptomeningeal carcinomatosis. * Unresolved toxicities from any prior therapy greater than CTCAE Grade 1 and prior platinum-therapy related Grade 2 neuropathies with the exception of alopecia and haemoglobin ≥ 9.0 g/dL. * Active/unstable cardiac diseases currently or within the last 6 months, clinically significant ECG abnormalities, and/or factors/medications that may affect QTc intervals. * History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement. * Known serious active infection including, but not limited to, tuberculosis, or HIV, HBV or HCV or gastrointestinal disease. * Receipt of live attenuated vaccine (including against COVID-19) within 30 days prior to the first dose of study intervention. * Past medical history of ILD, drug-induced ILD, radiation pneumonitis, which required steroid treatment, or any evidence of clinically active ILD. * Participants currently receiving medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP)3A4 or strong inhibitors of CYP1A2.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Orlando, Florida, 32804, United States
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Honolulu, Hawaii, 96819, United States
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New Brunswick, New Jersey, 08903, United States
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New York, New York, 10032, United States
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Nashville, Tennessee, 37232, United States
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Buenos Aires, C1125ABD, Argentina
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CABA, C1019ABS, Argentina
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Florida, B1602DQD, Argentina
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La Rioja, F5300COE, Argentina
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Rosario, 2000, Argentina
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Rosario, 2123, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Viedma, R8500ACE, Argentina
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Fremantle, 6160, Australia
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Southport, 4215, Australia
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Waratah NSW, 2298, Australia
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Westmead, 2145, Australia
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Brussels, 1000, Belgium
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Ghent, 9000, Belgium
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Roeselare, 8800, Belgium
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Belo Horizonte, 30110-022, Brazil
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Cachoeiro de Itapemirim, 29308-014, Brazil
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Ijuí, 98700-000, Brazil
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Porto Alegre, 90035-903, Brazil
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Porto Alegre, 90050-170, Brazil
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Salvador, 41253-190, Brazil
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Salvador, 41950-610, Brazil
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São Paulo, 04014-002, Brazil
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São Paulo, 04538-132, Brazil
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São Paulo, 04556-100, Brazil
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Vitória, 29043-260, Brazil
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H3T 1M5, Canada
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Santiago, 7500713, Chile
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Baoding, 71030, China
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Beijing, 100036, China
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Beijing, 101149, China
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Bengbu, 233004, China
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Changchun, 130012, China
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Changsha, 410011, China
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Changsha, 41003, China
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Chengdu, 610041, China
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Chongqing, 400016, China
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Fuzhou, 350001, China
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Fuzhou, 350011, China
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Hangzhou, 310022, China
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Harbin, 150040, China
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Hefei, 230031, China
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Jinan, 250022, China
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Linyi, 276000, China
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Nanchang, 330006, China
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Qingdao, 266035, China
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Shanghai, 200030, China
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Shenyang, 110001, China
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Shenzhen, 518020, China
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Wuhan, 430022, China
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Wuhan, 430079, China
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Xi'an, 710061, China
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Xi'an, 710100, China
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Xiangfan, 441021, China
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Yichang, 443003, China
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Zhengzhou, 450008, China
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Bobigny, 93000, France
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Brest, 29200, France
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Créteil, 94010, France
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Dijon, 21079, France
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Marseille, 13915, France
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Paris, 75005, France
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Poitiers, 86021, France
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Rennes, 35033, France
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Rouen, 76000, France
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Saint-Herblain, 44800, France
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Saint-Quentin, 02321, France
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Strasbourg, 67091, France
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Suresnes, 92151, France
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Berlin, 14165, Germany
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Chemnitz, 09113, Germany
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Frankfurt A. Main, 60590, Germany
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Gauting, 82131, Germany
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Immenhausen, 34376, Germany
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Löwenstein, 74245, Germany
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München, 81925, Germany
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Münster, 48149, Germany
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Wangen, 88239, Germany
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Athens, 115 27, Greece
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Athens, 11527, Greece
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Chaïdári, 124 62, Greece
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Heraklion, 71110, Greece
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Larissa, 41110, Greece
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Rio, 265 04, Greece
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Thessaloniki, 546 39, Greece
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Thessaloniki, 54622, Greece
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Hong Kong, 999077, Hong Kong
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Kowloon, Hong Kong
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Afula, 18341, Israel
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Ashdod, 7747629, Israel
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Be’er Ya‘aqov, 70300, Israel
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Hadera, 38100, Israel
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Jerusalem, 91031, Israel
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Tel Aviv, 6423906, Israel
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Avellino, 83100, Italy
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Aviano, 33081, Italy
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Catania, 95123, Italy
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Meldola, 47014, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Modena, 41124, Italy
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Monserrato, 09042, Italy
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Naples, 80138, Italy
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Orbassano, 10043, Italy
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Padova, 35128, Italy
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Parma, 43126, Italy
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Perugia, 6124, Italy
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Peschiera del Garda, 37019, Italy
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Roma, 00144, Italy
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Roma, 00152, Italy
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Treviso, 31100, Italy
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Bunkyō City, 113-8603, Japan
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Chūōku, 104-0045, Japan
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Fukuoka, 812-8582, Japan
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Hirosaki-shi, 036-8563, Japan
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Hiroshima, 730-8518, Japan
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Iwakuni-shi, 740-8510, Japan
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Kanazawa, 920-8641, Japan
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Kashiwa, 277-8577, Japan
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Kobe, 650-0017, Japan
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Kobe, 650-0046, Japan
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Kumamoto, 860-8556, Japan
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Kurume-shi, 830-0011, Japan
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Nagasaki, 852-8501, Japan
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Okayama, 700-8558, Japan
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Osaka, 534-0021, Japan
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Osakasayama-shi, 589-8511, Japan
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Sakaishi, 591-8555, Japan
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Sapporo, 003-0804, Japan
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Sapporo, 060-8638, Japan
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Sendai, 980-0873, Japan
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Sunto-gun, 411-8777, Japan
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Utsunomiya, 320-0834, Japan
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Wakayama, 641-8510, Japan
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Yokohama, 241-8515, Japan
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Kota Bharu, 15586, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Petaling Jaya, 47500, Malaysia
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Pulau Pinang, 10990, Malaysia
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Sabak Bernam, 88996, Malaysia
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Bacolod, 6100, Philippines
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Davao City, 8000, Philippines
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Manila, 1000, Philippines
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Quezon City, 1100, Philippines
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Quezon City, 1112, Philippines
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San Juan City, 1502, Philippines
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Lodz, 93-338, Poland
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Olsztyn, 10-357, Poland
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Singapore, 169610, Singapore
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Singapore, 308433, Singapore
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Goyang-si, 10408, South Korea
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Gyeonggi-do, 13620, South Korea
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Jinju, 660-702, South Korea
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Seoul, 06273, South Korea
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Seoul, 06351, South Korea
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Seoul, 08308, South Korea
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Seoul, 138-736, South Korea
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Seoul, 6591, South Korea
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Suwon, 16247, South Korea
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Badajoz, 6006, Spain
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Badalona, 8916, Spain
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Barcelona, 08036, Spain
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Barcelona, 8035, Spain
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Córdoba, 14004, Spain
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Girona, 17007, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Majadahonda, 28222, Spain
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Málaga, 29010, Spain
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Pontevedra, 36312, Spain
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Sabadell, 08208, Spain
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Seville, 41009, Spain
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Valencia, 46026, Spain
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Zaragoza, 50009, Spain
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Baden, CH-5405, Switzerland
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Zurich, 8063, Switzerland
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Chiayi City, 62247, Taiwan
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Hsinchu, 300, Taiwan
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Kaohsiung City, 83301, Taiwan
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Liuying, 736, Taiwan
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Taichung, 404, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 100, Taiwan
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Taipei, 11259, Taiwan
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Taipei, 112, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10700, Thailand
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Chanthaburi, 22000, Thailand
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Chiang Mai, 50200, Thailand
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Dusit, 10300, Thailand
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Hat Yai, 90110, Thailand
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Muang, 40002, Thailand
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Adana, 1370, Turkey (Türkiye)
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Ankara, 6800, Turkey (Türkiye)
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Edirne, 22030, Turkey (Türkiye)
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Istanbul, 34214, Turkey (Türkiye)
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Istanbul, 34722, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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London, SE1 9RT, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Wolverhampton, WV10 0QP, United Kingdom
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Can Tho, 900000, Vietnam
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Hanoi, 100000, Vietnam
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Hanoi, 10000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
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