RecruitingPhase 3NCT06692738

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)

Sponsor

AstraZeneca

Enrollment

880 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

Summary

The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This large international study is comparing two immunotherapy-based treatment combinations — one using a new drug called rilvegostomig (which targets two immune checkpoints at once) and one using the standard drug pembrolizumab — each combined with chemotherapy, as a first-line treatment for metastatic squamous non-small cell lung cancer (the most common form of advanced lung cancer). **You may be eligible if...** - Your lung cancer is confirmed as squamous non-small cell lung cancer that has spread (stage IV) and cannot be cured - Your tumor tests positive for the PD-L1 protein (at least 1% of tumor cells) - You have not received any prior treatment for advanced lung cancer - Your cancer does not have common genetic mutations that respond to targeted therapies - You have at least one measurable tumor on imaging - Your organs and bone marrow are functioning adequately **You may NOT be eligible if...** - Your cancer has a small cell or neuroendocrine component - You have active or unstable brain metastases requiring steroids - You have received prior immunotherapy (anti-PD-1 or anti-PD-L1 drugs) - You have a serious autoimmune disease or require immune-suppressing medications 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

DRUGRilvegostomig

Administered intravenously (IV) on Day 1 of each 21-day cycle

DRUGPembrolizumab

Administered intravenously (IV) on Day 1 of each 21-day cycle

DRUGCarboplatin

Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

DRUGPaclitaxel

Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

DRUGNab-paclitaxel

Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles

Locations(301)

Research Site

Tucson, Arizona, United States

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Springdale, Arkansas, United States

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Anaheim, California, United States

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Beverly Hills, California, United States

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Loma Linda, California, United States

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Los Alamitos, California, United States

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Redlands, California, United States

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San Francisco, California, United States

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Walnut Creek, California, United States

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West Haven, Connecticut, United States

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Newark, Delaware, United States

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Bay Pines, Florida, United States

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Fort Lauderdale, Florida, United States

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Gainesville, Florida, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Athens, Georgia, United States

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Atlanta, Georgia, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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Decatur, Illinois, United States

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Hinsdale, Illinois, United States

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Quincy, Illinois, United States

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Rockford, Illinois, United States

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Waterloo, Iowa, United States

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Lexington, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Alexandria, Louisiana, United States

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Baton Rouge, Louisiana, United States

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Covington, Louisiana, United States

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Shreveport, Louisiana, United States

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Shreveport, Louisiana, United States

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South Portland, Maine, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Detroit, Michigan, United States

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Grand Rapids, Michigan, United States

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Duluth, Minnesota, 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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Kansas City, Missouri, United States

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Lincoln, Nebraska, United States

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Camden, New Jersey, United States

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Buffalo, New York, United States

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East Syracuse, New York, United States

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Westbury, New York, United States

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Grand Forks, North Dakota, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Bend, Oregon, United States

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Medford, Oregon, United States

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Salem, Oregon, United States

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Hershey, Pennsylvania, United States

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York, Pennsylvania, United States

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Sioux Falls, South Dakota, United States

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Chattanooga, Tennessee, United States

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Nashville, Tennessee, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Kingwood, Texas, United States

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Lubbock, Texas, United States

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Round Rock, Texas, United States

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Fairfax, Virginia, United States

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Fredericksburg, Virginia, United States

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Olympia, Washington, United States

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Seattle, Washington, United States

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Silverdale, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Wenatchee, Washington, United States

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Buenos Aires, Argentina

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CABA, Argentina

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La Plata, Argentina

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Pilar, Argentina

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Rosario, Argentina

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Darlinghurst, Australia

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Hyde Park, Australia

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Southport, Australia

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Wollongong, Australia

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Innsbruck, Austria

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Krems, Austria

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Rankweil, Austria

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Vienna, Austria

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Vienna, Austria

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Anderlecht, Belgium

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Brussels, Belgium

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Charleroi, Belgium

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Kortrijk, Belgium

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Ottignies, Belgium

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Sint-Niklaas, Belgium

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Barretos, Brazil

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Florianópolis, Brazil

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Ijuí, Brazil

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Londrina, 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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Taubaté, Brazil

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Saint John, New Brunswick, Canada

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Sydney, Nova Scotia, Canada

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Hamilton, Ontario, Canada

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Sault Ste. Marie, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Beijing, China

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Beijing, China

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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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Changde, 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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Dalian, China

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Guangzhou, China

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Guangzhou, China

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Hangzhou, China

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Hangzhou, 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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Linhai, China

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Linyi, China

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Nanchang, China

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Ningbo, 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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Shenzhen, China

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Taiyuan, 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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Yangzhou, China

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Yueyang, China

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Zhengzhou, China

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Zhengzhou, China

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Avignon, France

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La Rochelle, France

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Lyon, France

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Nîmes, France

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Rennes, France

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Strasbourg, France

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Suresnes, France

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Toulon, France

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Bad Berka, Germany

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Berlin, Germany

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Berlin, Germany

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Bielefeld, Germany

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Cologne, Germany

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Esslingen am Neckar, Germany

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Frankfurt, Germany

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Gauting, Germany

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Giessen, Germany

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Großhansdorf, Germany

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Hamburg, Germany

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Hanover, Germany

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Hanover, Germany

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Heidelberg, Germany

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Hemer, Germany

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Homburg, Germany

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Kassel, Germany

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Kiel, Germany

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Krefeld, Germany

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Minden, Germany

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Moers, Germany

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München, Germany

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Regensburg, Germany

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Würzburg, 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, Hungary

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Gyöngyös - Mátraháza, Hungary

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Győr, Hungary

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Pécs, Hungary

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Székesfehérvár, Hungary

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Törökbálint, Hungary

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Calicut, India

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Delhi, India

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Kolkata, India

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Madurai, India

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Mumbai, India

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Nashik, India

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New Delhi, India

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Puducherry, India

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Surat, India

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Varanasi, India

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Florence, Italy

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Monza, Italy

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Orbassano, Italy

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Padova, Italy

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Peschiera del Garda, Italy

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Roma, Italy

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Amagasaki-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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Hiroshima, Japan

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Kawagoe-shi, Japan

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Kawasaki-shi, Japan

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Kitaadachi-gun, Japan

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Kitakyushu-shi, Japan

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Kobe, Japan

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Kōtoku, Japan

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Kumamoto, Japan

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Kumamoto, Japan

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Kyoto, Japan

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Matsusaka-shi, Japan

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Osaka, Japan

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Ota-shi, Japan

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Saitama-shi, Japan

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Sakai, Japan

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Sendai, Japan

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Shinjuku-ku, Japan

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Takaoka-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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Johor Bahru, Malaysia

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Kuala Lumpur, Malaysia

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Alkmaar, Netherlands

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Ede, Netherlands

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Groningen, Netherlands

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Leidschendam, Netherlands

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Veldhoven, Netherlands

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Zwolle, Netherlands

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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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Lima, Peru

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Lima, Peru

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Bialystok, Poland

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Biała Podlaska, Poland

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Bydgoszcz, Poland

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Bystra, Poland

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Lodz, Poland

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Poznan, Poland

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Warsaw, Poland

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San Juan, Puerto Rico

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San Juan, Puerto Rico

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Cheongju-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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Seoul, South Korea

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Suwon, South Korea

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Suwon, South Korea

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Barcelona, Spain

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Las Palmas de Gran Canaria, Spain

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Lleida, Spain

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Madrid, Spain

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Madrid, Spain

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Majadahonda, Spain

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Seville, Spain

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Kaohsiung City, Taiwan

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Kaohsiung City, Taiwan

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New Taipei City, Taiwan

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New Taipei City, Taiwan

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Taichung, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taoyuan, Taiwan

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Bangkok, Thailand

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Chiang Mai, Thailand

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Dusit, Thailand

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Nakhon Ratchasima, Thailand

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Songkhla, Thailand

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Ankara, Turkey (Türkiye)

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Antalya, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Yenimahalle, Turkey (Türkiye)

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Aberdeen, United Kingdom

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Cambridge, United Kingdom

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Edinburgh, United Kingdom

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Exeter, United Kingdom

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Greater London, 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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Newcastle upon Tyne, United Kingdom

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Preston, United Kingdom

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Can Tho, Vietnam

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Hanoi, Vietnam

Research Site

Ho Chi Minh City, Vietnam

Research Site

Vinh, Vietnam

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NCT06692738

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