RecruitingPhase 3NCT07291037

Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations

A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)

Sponsor

AstraZeneca

Enrollment

400 participants

Start Date

Oct 31, 2025

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer (NSCLC)

Summary

TROPION-Lung17 will measure the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with trophoblast cell surface protein 2 (TROP2) positive advanced or metastatic lung cancer without actionable genomic alterations (AGA).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This large Phase III trial compares a new antibody-drug conjugate called datopotamab deruxtecan (Dato-DXd) against standard docetaxel chemotherapy in people with advanced non-squamous non-small cell lung cancer (NSCLC) who have already tried other treatments. **You may be eligible if...** - You have advanced non-squamous NSCLC (stage IIIB, IIIC, or IV) - Your tumor has tested negative for EGFR, ALK, ROS1, KRAS G12C, and other actionable gene mutations - You have already received prior treatment for advanced lung cancer - You are in good enough physical condition to receive chemotherapy **You may NOT be eligible if...** - Your tumor has any of the actionable genetic mutations listed above - You have not yet received prior treatment for advanced disease - You have conditions that prevent safe use of either study drug 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

DRUGDatopotamab deruxtecan (Dato-DXd)

Dato-DXd administered intravenously (IV)

DRUGDocetaxel

Docetaxel administered intravenously (IV)

Locations(204)

Research Site

Chandler, Arizona, United States

Research Site

Gilbert, Arizona, United States

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Goodyear, Arizona, United States

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Duarte, California, United States

Research Site

Irvine, California, United States

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La Jolla, California, United States

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Loma Linda, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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Grand Junction, Colorado, United States

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Wheat Ridge, Colorado, United States

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Newark, Delaware, United States

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Washington D.C., District of Columbia, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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St. Petersburg, Florida, United States

Research Site

Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Marietta, Georgia, United States

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Newnan, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Niles, Illinois, United States

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Zion, Illinois, United States

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Louisville, Kentucky, United States

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South Portland, Maine, United States

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Baltimore, Maryland, United States

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Brandywine, Maryland, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Rochester, Minnesota, United States

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Bridgeton, Missouri, United States

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Columbia, Missouri, United States

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Lincoln, Nebraska, United States

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Albuquerque, New Mexico, United States

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East Syracuse, New York, United States

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Portland, Oregon, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Greenville, South Carolina, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Denton, Texas, United States

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Plano, Texas, United States

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Charlottesville, Virginia, United States

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Fairfax, Virginia, United States

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Williamsburg, Virginia, United States

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Tacoma, Washington, United States

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Morgantown, West Virginia, United States

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Eau Claire, Wisconsin, United States

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Gosford, Australia

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Kogarah, Australia

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South Brisbane, Australia

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St Albans, Australia

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Wollongong, Australia

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Graz, Austria

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Linz, Austria

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Rankweil, Austria

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Vienna, Austria

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Vienna, Austria

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Hasselt, Belgium

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La Louvière, Belgium

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Libramont-Chevigny, Belgium

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Namur, Belgium

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Sint-Niklaas, Belgium

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Porto Alegre, Brazil

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Porto Alegre, 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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Vancouver, British Columbia, Canada

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Moncton, New Brunswick, Canada

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Halifax, Nova Scotia, Canada

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Brampton, Ontario, Canada

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Hamilton, Ontario, Canada

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Toronto, Ontario, Canada

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Beijing, China

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Beijing, China

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Beijing, China

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Changchun, China

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Changsha, China

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Chengdu, China

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Chengdu, China

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Chongqing, China

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Fuzhou, China

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Guangzhou, China

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Hangzhou, China

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Harbin, China

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Hefei, China

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Jiamusi, China

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Jinan, China

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Nanchang, China

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Nanjing, China

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Shanghai, China

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Shanghai, China

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Shanghai, China

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Shantou, China

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Shenyang, China

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Tianjin, China

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Wuhan, China

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Wuhan, China

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Xuzhou, China

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Zhengzhou, China

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Zhengzhou, China

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Boulogne-Billancourt, France

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Lyon, France

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Marseille, France

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Saint-Herblain, France

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Toulouse, France

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Bad Saarow, Germany

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Bielefeld, Germany

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Bonn, Germany

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Cologne, Germany

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Essen, Germany

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Frankfurt, 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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Krefeld, Germany

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Minden, Germany

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Oldenburg, Germany

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Stuttgart, Germany

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Troisdorf, Germany

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Velbert, Germany

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Budapest, Hungary

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Budapest, Hungary

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Budapest, Hungary

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Debrecen, Hungary

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Gyöngyös - Mátraháza, Hungary

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Győr, Hungary

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Gyula, Hungary

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Kecskemét, Hungary

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Szolnok, Hungary

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Törökbálint, Hungary

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Bangalore, India

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Kolkata, India

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Mumbai, India

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Nashik, India

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New Delhi, India

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Milan, Italy

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Milan, Italy

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Monza, Italy

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Orbassano, Italy

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Padova, Italy

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Rozzano, Italy

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Chūōku, Japan

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Fukuoka, Japan

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Hiroshima, Japan

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Iwakuni-shi, Japan

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Kashiwa, Japan

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Kawasaki-shi, Japan

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Kyoto, Japan

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Matsuyama, Japan

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Nagoya, Japan

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Niigata, Japan

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Osaka, Japan

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Osakasayama-shi, Japan

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Sendai, Japan

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Sunto-gun, Japan

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Yokohama, Japan

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Lodz, Poland

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Olsztyn, Poland

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Poznan, Poland

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Warsaw, Poland

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Goyang-si, South Korea

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Incheon, 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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A Coruña, Spain

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Barcelona, Spain

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L'Hospitalet de Llobregat, Spain

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Madrid, Spain

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Málaga, Spain

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Seville, Spain

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Zaragoza, Spain

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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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Taipei, Taiwan

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Taoyuan, Taiwan

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Bangkok, Thailand

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Bangkok, Thailand

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Bangkok, Thailand

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Hat Yai, Thailand

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Muang, Thailand

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Ankara, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Huddersfield, 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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Maidstone, United Kingdom

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Norwich, United Kingdom

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Stoke-on-Trent, United Kingdom

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Hanoi, Vietnam

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Ho Chi Minh City, Vietnam

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Ho Chi Minh City, Vietnam

Research Site

Vinh, Vietnam

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NCT07291037

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