New pill could keep lung cancer away after surgery

NCT ID NCT02511106

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This phase 3 trial tests a daily pill called osimertinib (AZD9291) against a placebo in 682 people with a specific type of lung cancer (EGFR-mutated, stages IB to IIIA) who have had surgery to remove their tumor. The goal is to see if the drug can delay or prevent the cancer from coming back. Participants take the pill once daily for up to 3 years, and those who relapse may receive the drug openly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Osimertinib (AZD9291), a targeted cancer pill
What this could lead to: If successful, this could provide a new standard treatment to delay or prevent lung cancer recurrence after surgery.
What could go wrong: This is a late-stage trial, but results may not apply to all patients. Side effects like rash, diarrhea, or lung inflammation are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

682 people

The number who actually took part.

Started

Oct 2015

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 130 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female, aged at least 18 years. 2. Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology 3. MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care. 4. Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of pathologic criteria. 5. Confirmation by the central laboratory that the tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M. 6. Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour. 7. Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization. 8. World Health Organization Performance Status of 0 to 1. 9. Female patients should be using adequate contraceptive measures, should not be breast feeding, and must have a negative pregnancy test prior to first dose of study drug; or female patients must have an evidence of non-child-bearing potential. Exclusion Criteria: 1. Treatment with any of the following: * Pre-operative or post-operative or planned radiation therapy for the current lung cancer * Pre-operative (neo-adjuvant) platinum based or other chemotherapy * Any prior anticancer therapy * Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time * Major surgery (including primary tumour surgery, excluding placement of vascular access) within 4 weeks of the first dose of study drug * Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4 * Treatment with an investigational drug within five half-lives of the compound or any of its related material. 2. Patients who have had only segmentectomies or wedge resections 3. History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for \> 5 years following the end of treatment. 4. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy. 5. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). 6. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291. 7. Any of the following cardiac criteria: * Mean resting corrected QT interval (QTc) \>470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value. * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG. * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval. 8. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. 9. Inadequate bone marrow reserve or organ function.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stage IB-IIIA non-small cell lung carcinoma

Contacts and locations

Locations

Research Site

Los Angeles, California, 90048, United States
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Santa Monica, California, 90404, United States
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Santa Rosa, California, 95403, United States
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Torrance, California, 90505, United States
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Grand Junction, Colorado, 81501, United States
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New Haven, Connecticut, 06520, United States
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Norwalk, Connecticut, 06856, United States
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Fort Myers, Florida, 33901, United States
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Pembroke Pines, Florida, 33028, United States
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St. Petersburg, Florida, 33705, United States
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Athens, Georgia, 30607, United States
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Honolulu, Hawaii, 96819, United States
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Chicago, Illinois, 60612, United States
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Elk Grove Village, Illinois, 60007, United States
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Bethesda, Maryland, 20817, United States
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Brick, New Jersey, 08724, United States
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Florham Park, New Jersey, 07932, United States
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Mineola, New York, 11501, United States
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Pawtucket, Rhode Island, 02860, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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San Antonio, Texas, 78229, United States
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Fort Belvoir, Virginia, 22060, United States
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Bedford Park, 5042, Australia
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Camperdown, 2050, Australia
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Darlinghurst, 2010, Australia
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Heidelberg, 3084, Australia
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Kogarah, 2217, Australia
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Kurralta Park, 5037, Australia
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Woolloongabba, 4102, Australia
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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Kortrijk, 8500, Belgium
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Barretos, 14784-400, Brazil
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Cachoeira de Itapemirim, 29308-055, Brazil
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Curitiba, 81520-060, Brazil
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Florianópolis, 88034-000, Brazil
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Fortaleza, 60810-180, Brazil
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Lajeado, 95900000, Brazil
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Porto Alegre, 90619-900, Brazil
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Rio de Janeiro, 22793-080, Brazil
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Salvador, 40170-110, Brazil
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São José do Rio Preto, 15025-100, Brazil
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São Paulo, 01321-001, Brazil
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Toronto, Ontario, M5G 2M9, Canada
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Beijing, 100029, China
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Beijing, 100142, China
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Beijing, 100210, China
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Beijing, 100730, China
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Changchun, 130012, China
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Changchun, 130021, China
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Dalian, 116027, China
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Guangzhou, 510060, China
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Guangzhou, 510120, China
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Guangzhou, 510180, China
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Hangzhou, 310003, China
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Hangzhou, 310009, China
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Hangzhou, 310022, China
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Kunming, 650118, China
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Nanjing, 210029, China
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Nanning, 530021, China
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Shanghai, 200030, China
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Shanghai, 200032, China
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Shanghai, 200072, China
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Shenyang, 110001, China
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Suzhou, 215006, China
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Tianjin, 300050, China
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Tianjin, 300051, China
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Tianjin, 300060, China
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Ürümqi, 830000, China
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Xi'an, 710061, China
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Xiamen, 361004, China
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Yangzhou, 225001, China
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Zhengzhou, 450008, China
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Bron, 69677, France
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Lille, 59000, France
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Limoges, 87042, France
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Lyon, 69008, France
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Paris, 75020, France
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Aachen, 52074, Germany
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Berlin, 12351, Germany
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Berlin, 13125, Germany
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Berlin, 13359, Germany
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Cologne, 51109, Germany
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Coswig, 01640, Germany
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Gauting, 82131, Germany
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Gerlingen, 70839, Germany
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Großhansdorf, 22927, Germany
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Halle, 06120, Germany
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Hamburg, 20251, Germany
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Homburg, 66421, Germany
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Immenhausen, 34376, Germany
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Kassel, 34125, Germany
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Lübeck, 23538, Germany
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Würzburg, 97074, Germany
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Hong Kong, 150001, Hong Kong
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Hong Kong, Hong Kong
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King's Park, 150001, Hong Kong
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Budapest, 1083, Hungary
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Budapest, 1121, Hungary
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Deszk, 6772, Hungary
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Székesfehérvár, 8000, Hungary
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Törökbálint, 2045, Hungary
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Beersheba, 8410101, Israel
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Haifa, 31999, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 4428164, Israel
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Petah Tikva, 4941492, Israel
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Ramat Gan, 5262000, Israel
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Tel Aviv, 6423906, Israel
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Bari, 70124, Italy
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Bergamo, 24127, Italy
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Bologna, 40138, Italy
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Cremona, 26100, Italy
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Florence, 50134, Italy
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Lucca, 55100, Italy
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Meldola, 47014, Italy
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Milan, 20132, Italy
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Milan, 20141, Italy
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Milan, 20162, Italy
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Novara, 28100, 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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Roma, 00152, Italy
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Bunkyō City, 113-8431, Japan
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Fukuoka, 812-8582, Japan
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Hirakata-shi, 573-1191, Japan
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Hiroshima, 730-8518, Japan
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Hiroshima, 734-8551, Japan
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Kanazawa, 920-8641, Japan
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Kashiwa, 277-8577, Japan
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Kitakyushu-shi, 807-8555, Japan
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Kobe, 650-0047, Japan
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Kurume-shi, 830-0011, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 453-8511, Japan
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Niigata, 951-8566, Japan
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Osakasayama-shi, 589-8511, Japan
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Sagamihara-shi, 252-0375, Japan
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Sakaishi, 591-8555, Japan
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Sasebo-shi, 857-8511, Japan
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Sendai, 980-0873, Japan
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Shinjuku-ku, 160-0023, Japan
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Sunto-gun, 411-8777, Japan
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Ube-shi, 755-0241, Japan
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Yokohama, 240-8555, Japan
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Yokohama, 241-8515, Japan
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Yonago-shi, 683-8504, Japan
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Amsterdam, 1081 HV, Netherlands
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Arnhem, 6815 AD, Netherlands
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Hoofddorp, 2134 TM, Netherlands
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Zwolle, 8025 AB, Netherlands
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Krakow, 31-202, Poland
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Lodz, 90-302, Poland
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Otwock, 05-400, Poland
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Poznan, 60-569, Poland
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Racibórz, 47-400, Poland
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Warsaw, 02-781, Poland
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Wieliszew, 05-135, Poland
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Bucharest, 031422, Romania
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Bucharest, 050098, Romania
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Cluj-Napoca, 400015, Romania
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Craiova, 200385, Romania
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Focşani, 620165, Romania
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Iași, 700483, Romania
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Timișoara, 300210, Romania
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Arkhangelsk, 163045, Russia
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Kazan', 420029, Russia
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Moscow, 115478, Russia
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Moscow, 143423, Russia
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Obninsk, 249036, Russia
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Omsk, 644013, Russia
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Pyatigorsk, 357502, Russia
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Rostov-on-Don, 344037, Russia
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Ryazan, 390011, Russia
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Saint Petersburg, 194291, Russia
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Saint Petersburg, 195271, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197758, Russia
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Saint Petersburg, 198255, Russia
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Cheongju-si, 28644, South Korea
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Seoul, 02841, South Korea
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Seoul, 05030, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Seoul, 07061, South Korea
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Suwon, 16247, South Korea
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Suwon, 16499, South Korea
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A Coruña, 15006, Spain
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Barcelona, 08041, Spain
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Donostia / San Sebastian, 20014, Spain
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Elche, 03203, Spain
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Las Palmas de Gran Canaria, 35016, Spain
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Madrid, 08035, Spain
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Madrid, 28007, Spain
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Madrid, 28040, Spain
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Madrid, 28046, Spain
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Majadahonda, 28222, Spain
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Málaga, 29010, Spain
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Valencia, 46010, Spain
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Valencia, 46026, Spain
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Zaragoza, 50009, Spain
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Linköping, 581 85, Sweden
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Changhua, 50006, Taiwan
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Putzu City, 0613, Taiwan
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Taichung, 402, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 70403, Taiwan
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Tainan, 73657, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 112, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10700, Thailand
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Chiang Rai, 57000, Thailand
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Khon Kaen, 40002, Thailand
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Mueang, 50200, Thailand
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Phitsanulok, 65000, Thailand
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Songkhla, 90110, Thailand
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Ankara, 06280, Turkey (Türkiye)
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Ankara, 6500, Turkey (Türkiye)
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Bursa, 16059, Turkey (Türkiye)
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Istanbul, 34069, Turkey (Türkiye)
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Istanbul, 34093, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Istanbul, 34722, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Dnipro, 49102, Ukraine
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Lviv, 79031, Ukraine
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Sumy, 40022, Ukraine
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Uzhhorod, 88000, Ukraine
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Vinnytsia, 21029, Ukraine
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Zaporizhzhya, 69040, Ukraine
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Hanoi, 100000, Vietnam
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Hanoi, 10000, Vietnam
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Ho Chi Minh City, 70000, Vietnam