RecruitingPhase 3NCT05261399

Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment

A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated, MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON).


Sponsor

AstraZeneca

Enrollment

324 participants

Start Date

Aug 3, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Clinical study to investigate the efficacy and safety of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with Osimertinib.


Eligibility

Min Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment options for people with advanced non-small cell lung cancer (NSCLC) whose cancer has grown while on a drug called osimertinib: one option is a combination of savolitinib (a targeted drug) plus osimertinib, and the other is standard platinum-based chemotherapy. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with advanced or metastatic NSCLC with an EGFR mutation (such as exon 19 deletion or L858R) - Your cancer has grown after treatment with osimertinib - Your tumor has been tested and shows a specific change called MET overexpression or amplification - You have a tumor tissue sample available **You may NOT be eligible if...** - Your cancer has not progressed on osimertinib - Your tumor does not have the required MET changes - You have serious heart, liver, or lung conditions that would make treatment unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSavolitinib

300 mg savolitinib (3 × 100 mg tablets twice daily) Administrative route : oral

DRUGOsimertinib

80 mg osimertinib (1 × 80 mg tablet once daily) Administrative route : oral

DRUGPemetrexed

Pemetrexed (500 mg/m2) Administrative route : IV infusion

DRUGCisplatin

Cisplatin (75 mg/m2) or Administrative route : IV infusion

DRUGCarboplatin

Carboplatin (AUC5) Administrative route : IV infusion


Locations(283)

Research Site

La Jolla, California, United States

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Orange City, Florida, United States

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Orlando, Florida, United States

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Honolulu, Hawaii, United States

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Evergreen Park, Illinois, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Florham Park, New Jersey, United States

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New Brunswick, New Jersey, United States

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New York, New York, United States

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Canton, Ohio, United States

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Nashville, Tennessee, United States

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Berazategui, Argentina

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Buenos Aires, Argentina

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CABA, Argentina

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Córdoba, Argentina

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Florida, Argentina

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La Rioja, Argentina

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Rosario, Argentina

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Rosario, Argentina

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San Miguel de Tucumán, Argentina

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Viedma, Argentina

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Clayton, Australia

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Fremantle, Australia

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Geelong, Australia

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Liverpool, Australia

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Southport, Australia

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Waratah NSW, Australia

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Westmead, Australia

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Graz, Austria

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Salzburg, Austria

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Vienna, Austria

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Brussels, Belgium

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Brussels, Belgium

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Edegem, Belgium

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Ghent, Belgium

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Hasselt, Belgium

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Mons, Belgium

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Roeselare, Belgium

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Sint-Niklaas, Belgium

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Belo Horizonte, Brazil

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Brasília, Brazil

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Cachoeiro de Itapemirim, Brazil

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Curitiba, Brazil

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Ijuí, Brazil

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Ipatinga, 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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Rio de Janeiro, Brazil

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Rio de Janeiro, Brazil

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Salvador, Brazil

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Salvador, 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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Vitória, Brazil

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Haskovo, Bulgaria

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Pleven, Bulgaria

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Plovdiv, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Vratsa, Bulgaria

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Calgary, Alberta, Canada

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Mississauga, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Santiago, Chile

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Santiago, Chile

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Temuco, Chile

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Baoding, China

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Beijing, China

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Beijing, China

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Bengbu, China

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Changchun, China

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Changsha, China

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Changsha, China

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Changsha, China

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Chengdu, China

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Chongqing, China

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Fuzhou, China

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Fuzhou, China

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Hangzhou, China

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Hankou,Wuhan, China

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Harbin, China

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Hefei, China

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Jinan, China

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Linyi, China

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Nanchang, China

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Qingdao, China

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Shanghai, China

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Shenyang, China

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Shenzhen, China

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Wuhan, China

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Xi'an, China

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Xi'an, China

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Xiangfan, China

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Yichang, China

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Zhengzhou, China

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Angers, France

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Bobigny, France

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Bordeaux, France

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Brest, France

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Créteil, France

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Dijon, France

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Marseille, France

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Montpellier, France

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Paris, France

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Paris, France

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Poitiers, France

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Rennes, France

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Rouen, France

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Saint-Herblain, France

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Saint-Quentin, France

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Strasbourg, France

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Suresnes, France

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Berlin, Germany

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Berlin, Germany

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Chemnitz, Germany

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Frankfurt A. Main, Germany

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Gauting, Germany

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Homburg, Germany

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Immenhausen, Germany

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Löwenstein, Germany

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München, Germany

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Münster, Germany

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Stuttgart, Germany

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Wangen, Germany

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Athens, Greece

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Athens, Greece

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Chaïdári, Greece

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Heraklion, Greece

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Larissa, Greece

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Rio, Greece

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Thessaloniki, Greece

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Thessaloniki, Greece

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Hong Kong, Hong Kong

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Kowloon, Hong Kong

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Afula, Israel

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Ashdod, Israel

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Be’er Ya‘aqov, Israel

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Hadera, Israel

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Jerusalem, Israel

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Tel Aviv, Israel

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Avellino, Italy

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Aviano, Italy

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Catania, Italy

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Meldola, Italy

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Milan, Italy

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Milan, Italy

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Modena, Italy

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Monserrato, Italy

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Naples, Italy

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Orbassano, Italy

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Padova, Italy

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Parma, Italy

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Perugia, Italy

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Peschiera del Garda, Italy

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Roma, Italy

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Roma, Italy

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Treviso, Italy

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Bunkyō City, Japan

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Chūōku, Japan

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Fukuoka, Japan

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Hirosaki-shi, 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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Kobe, Japan

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Kobe, Japan

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Kumamoto, Japan

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Kurume-shi, Japan

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Matsuyama, Japan

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Nagasaki, Japan

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Okayama, Japan

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Osaka, Japan

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Osakasayama-shi, Japan

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Sakaishi, Japan

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Sapporo, Japan

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Sapporo, Japan

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Sendai, Japan

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Sunto-gun, Japan

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Utsunomiya, Japan

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Wakayama, Japan

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Yokohama, Japan

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Kota Bharu, Malaysia

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Kuala Lumpur, Malaysia

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Petaling Jaya, Malaysia

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Pulau Pinang, Malaysia

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Sabak Bernam, Malaysia

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Amsterdam, Netherlands

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Bacolod, Philippines

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Baguio City, Philippines

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Cebu, Philippines

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Cebu City, Philippines

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Davao City, Philippines

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Manila, Philippines

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Quezon City, Philippines

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Quezon City, Philippines

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Quezon City, Philippines

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San Juan City, Philippines

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Bialystok, Poland

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Krakow, Poland

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Lodz, Poland

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Olsztyn, Poland

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Chelyabinsk, Russia

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Moscow, Russia

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Saint Petersburg, Russia

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Tomsk, Russia

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Singapore, Singapore

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Singapore, Singapore

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Goyang-si, South Korea

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Gyeonggi-do, South Korea

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Incheon, South Korea

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Jinju, 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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Badajoz, Spain

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Badalona, Spain

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Barcelona, Spain

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Barcelona, Spain

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Córdoba, Spain

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Girona, 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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Pontevedra, Spain

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Sabadell, Spain

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Seville, Spain

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Valencia, Spain

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Zaragoza, Spain

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Baden, Switzerland

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Basel, Switzerland

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Bern, Switzerland

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Winterthur, Switzerland

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Zurich, Switzerland

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Chiayi City, Taiwan

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Hsinchu, Taiwan

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Kaohsiung City, Taiwan

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Liuying, Taiwan

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Taichung, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Bangkok, Thailand

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Bangkok, Thailand

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Chanthaburi, Thailand

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Chiang Mai, Thailand

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Dusit, Thailand

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Hat Yai, Thailand

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Muang, Thailand

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Adana, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Edirne, 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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Bristol, United Kingdom

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Leicester, United Kingdom

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Liverpool, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Newport, United Kingdom

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Reading, United Kingdom

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Wolverhampton, United Kingdom

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Can Tho, Vietnam

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Hanoi, Vietnam

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Hanoi, Vietnam

Research Site

Ho Chi Minh City, Vietnam

Research Site

Ho Chi Minh City, Vietnam

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NCT05261399


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