RecruitingPhase III🇵🇱 PolandEN originalGastric cancerHER2 positiveMetastatic / advanced

A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Potwierdzony rak żołądka typu HER2-dodatni
  • •Guz nigdy wcześniej nie leczony, który nie da się usunąć operacyjnie lub rozprzestrzenił się na inne części ciała
  • •Ogólny stan zdrowia pozwalający na leczenie (ocena funkcjonalna 0-1)
  • •Dostępna próbka tkanki guza do badań laboratoryjnych
  • •Prawidłowo funkcjonujące narządy i szpik kostny
  • •Serce pompuje prawidłowo (frakcja wyrzutu lewej komory ≥50%)
  • •Brak poprzedniego leczenia przeciwnowotworowego lub wystarczająco długa przerwa od ostatniego leczenia

✗ Disqualifies

  • •Uszkodzenie górnego przewodu pokarmowego uniemożliwiające przyjmowanie leków
  • •Niedobór enzymu warunkującego metabolizm pewnych leków przeciwnowotworowych
  • •Wcześniejsze niepowodzenia lub alergię na stosowane leki (pembrolizumab, trastuzumab lub chemioterapię)
  • •Przerzuty do mózgu lub rdzenia kręgowego, jeśli powodują objawy
  • •Aktywne lub niekontrolowane zakażenie, w tym gruźlicę lub zapalenie wątroby
  • •Niedawne podanie żywej szczepionki
  • •Aktywne zapalenie autoimmunologiczne wymagające stałego leczenia sterydami
  • •Poważne problemy z sercem lub zaburzenia psychiczne

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
October 16, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (304)

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Anchorage, United States

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Phoenix, United States

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Duarte, United States

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La Jolla, United States

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Los Alamitos, United States

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Los Angeles, United States

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Los Angeles, United States

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Santa Monica, United States

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Solvang, United States

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Upland, United States

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Walnut Creek, United States

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Aurora, United States

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Newark, United States

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Jacksonville, United States

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Jacksonville, United States

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Orlando, United States

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Athens, United States

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Marietta, United States

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Chicago, United States

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Chicago, United States

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Evanston, United States

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Hinsdale, United States

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Niles, United States

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Dyer, United States

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Waukee, United States

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Lexington, United States

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Louisville, United States

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Silver Spring, United States

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Boston, United States

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Boston, United States

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Worcester, United States

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Detroit, United States

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Grand Rapids, United States

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Burnsville, United States

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Kansas City, United States

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St Louis, United States

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Omaha, United States

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Reno, United States

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Summit, United States

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Santa Fe, United States

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Albany, United States

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Clifton Park, United States

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New Hyde Park, United States

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New York, United States

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Cincinnati, United States

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Columbus, United States

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Oklahoma City, United States

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Lancaster, United States

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Knoxville, United States

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Nashville, United States

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Dallas, United States

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Round Rock, United States

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Webster, United States

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Charlottesville, United States

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Fairfax, United States

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Fairfax, United States

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Richmond, United States

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Charleston, United States

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Madison, United States

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Buenos Aires, Argentina

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Ciudad Autónoma Buenos Aires, Argentina

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Ciudad de Buenos Aires, Argentina

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Rosario, Argentina

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Rosario, Argentina

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Viedma, Argentina

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Darlinghurst, Australia

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Heidelberg, Australia

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Murdoch, Australia

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Westmead, Australia

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Linz, Austria

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Salzburg, Austria

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Vienna, Austria

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Wiener Neustadt, Austria

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Edegem, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Liège, Belgium

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Barretos, Brazil

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Brasília, Brazil

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Campo Grande, Brazil

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Natal, Brazil

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Porto Alegre, Brazil

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Recife, Brazil

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Salvador, Brazil

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São Paulo, Brazil

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Vitória, Brazil

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Calgary, Canada

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Edmonton, Canada

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Winnipeg, Canada

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Barrie, Canada

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Brampton, Canada

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Hamilton, Canada

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Toronto, Canada

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Chicoutimi, Canada

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Lévis, Canada

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Montreal, Canada

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Port Montt, Chile

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Rancagua, Chile

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Santiago, Chile

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Santiago, Chile

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Santiago, Chile

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Temuco, Chile

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Viña del Mar, Chile

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Anyang, 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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Chengdu, China

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Fuzhou, China

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Fuzhou, China

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Guangzhou, China

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Guangzhou, 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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Hefei, China

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Jinan, China

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Kunming, China

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Lanzhou, China

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Linfen, China

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Linyi, China

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Nanchang, China

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Nanjing, China

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Nanjing, China

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Shandong, China

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Shanghai, China

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Shanghai, China

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Shanghai, China

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Shenyang, China

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Shenyang, China

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Shijiazhuang, China

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Tianjin, China

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Wenzhou, 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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Xining, China

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Yinchuan, China

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Zhengzhou, China

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Bordeaux, France

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Caen, France

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Clermont-Ferrand, France

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Dijon, France

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Lyon, France

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Marseille, France

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Poitiers, France

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Rennes, France

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Toulouse, France

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Vandœuvre-lès-Nancy, France

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Villejuif, France

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Augsburg, Germany

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Bad Saarow, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Braunschweig, Germany

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Chemnitz, Germany

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Düsseldorf, Germany

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Erlangen, Germany

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Essen, Germany

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Frankfurt, Germany

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Göttingen, Germany

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Hamburg, Germany

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Leipzig, Germany

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Ludwigshafen, Germany

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Lübeck, Germany

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Mainz, Germany

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Mannheim, Germany

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Regensburg, Germany

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Tübingen, Germany

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Ulm, Germany

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Hong Kong, Hong Kong

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Hong Kong, Hong Kong

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Hong Kong, Hong Kong

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Budapest, Hungary

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Budapest, Hungary

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Budapest, Hungary

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Gyöngyös, Hungary

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Győr, Hungary

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Gyula, Hungary

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Zalaegerszeg, Hungary

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Ansārinagar, India

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Bangalore, India

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Delhi, India

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Delhi, India

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Hyderabad, India

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Kolkata, India

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Mumbai, India

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Varanasi, India

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Cagliari, Italy

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Florence, Italy

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Milan, Italy

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Naples, Italy

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Padova, Italy

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Rozzano, Italy

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Torino, Italy

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Tricase, Italy

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Akashi-shi, Japan

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Bunkyō City, Japan

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Chūōku, Japan

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Fukuoka, Japan

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Fukuoka, Japan

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Hidaka-shi, Japan

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Hirakata-shi, Japan

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Hiroshima, Japan

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Kasama-shi, Japan

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Kita-gun, Japan

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Kitaadachi-gun, Japan

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Kōtoku, Japan

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Matsuyama, Japan

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Niigata, Japan

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Osaka, Japan

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Osakasayama-shi, Japan

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Ota-shi, Japan

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Sakaishi, Japan

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Sendai, Japan

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Shiwa-gun, Japan

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Suita-shi, Japan

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Sunto-gun, Japan

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Toyoake-shi, Japan

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Yokohama, Japan

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Yokohama, Japan

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George Town, Malaysia

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Ipoh, Malaysia

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Kuala Lumpur, Malaysia

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Kuala Lumpur, Malaysia

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Sabak Bernam, Malaysia

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Amsterdam, Netherlands

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Arnhem, Netherlands

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Leiden, Netherlands

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Arequipa, Peru

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Callao, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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San Isidro, Peru

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Bialystok, Poland

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Gdansk, Poland

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Koszalin, Poland

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Lodz, Poland

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Olsztyn, Poland

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Przemyśl, Poland

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Tomaszów Mazowiecki, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Rio Piedras, Puerto Rico

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Daegu, South Korea

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Goyang-si, South Korea

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Gyeonggi-do, South Korea

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Jeonnam, 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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Badalona, Spain

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Barcelona, Spain

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Madrid, Spain

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Madrid, Spain

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Ourense, Spain

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Santander, Spain

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Seville, Spain

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Valencia, Spain

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Kaohsiung City, Taiwan

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Tainan, 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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Banphaeo, Thailand

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Dusit, Thailand

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Khon Kaen, Thailand

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Muang, Thailand

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Ankara, Turkey (Türkiye)

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Antalya, Turkey (Türkiye)

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Diyarbakır, Turkey (Türkiye)

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Erzurum, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Mezitli, Turkey (Türkiye)

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Cambridge, United Kingdom

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Coventry, United Kingdom

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Dundee, United Kingdom

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London, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Sutton, 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

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Hồ Chí Minh, Vietnam

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Viet Tri, Vietnam

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Vinh, Vietnam

Trial contact

AstraZeneca Clinical Study Information Center

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/12/2026.

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