RecruitingPhase 3NCT06868277

A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer

A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients With PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04)

Sponsor

AstraZeneca

Enrollment

830 participants

Start Date

Apr 10, 2025

Study Type

INTERVENTIONAL

Conditions

Carcinoma, Non-Small Cell Lung

Summary

The purpose of ARTEMIDE-Lung04 is to assess the efficacy and safety of rilvegostomig compared with pembrolizumab monotherapy as 1L treatment in participants with mNSCLC and whose tumors express PD-L1.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This large global study compares two treatments for first-line metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression: a new combination drug (rilvegostomig, which targets both PD-1 and TIGIT) versus the current standard (pembrolizumab alone). **You may be eligible if...** - You have confirmed stage IV (metastatic) NSCLC that cannot be treated with curative surgery or radiation - Your tumor has high PD-L1 expression (TPS ≥50%) - Your tumor does not have certain mutations (EGFR, ALK, or ROS1) that have their own targeted therapies - You have not previously received treatment for metastatic lung cancer **You may NOT be eligible if...** - You have active autoimmune disease requiring systemic treatment - You have already received immunotherapy or targeted therapy for this cancer - You have untreated brain metastases - 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

BIOLOGICALRilvegostomig

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

BIOLOGICALPembrolizumab

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

Locations(294)

Research Site

La Mesa, California, United States

Research Site

Los Alamitos, California, United States

Research Site

Newark, Delaware, United States

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Bay Pines, Florida, United States

Research Site

Clearwater, Florida, United States

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St. Petersburg, Florida, United States

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Marietta, Georgia, United States

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Chicago, Illinois, United States

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Decatur, Illinois, United States

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Des Moines, Iowa, United States

Research Site

Waterloo, Iowa, United States

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Leawood, Kansas, United States

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Lexington, Kentucky, United States

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Owensboro, Kentucky, United States

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Bethesda, Maryland, United States

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Frederick, Maryland, United States

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Silver Spring, Maryland, United States

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Towson, Maryland, United States

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Bridgeton, Missouri, United States

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Lincoln, Nebraska, United States

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Paramus, 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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Fresh Meadows, New York, United States

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Rochester, New York, United States

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Westbury, New York, United States

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Canton, Ohio, United States

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Fountain Hill, Pennsylvania, United States

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Kittanning, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Round Rock, Texas, United States

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Aberdeen, Washington, United States

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Renton, Washington, United States

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Charleston, West Virginia, United States

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Morgantown, West Virginia, United States

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CABA, Argentina

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Córdoba, Argentina

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Pilar, Argentina

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Rosario, Argentina

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Rosario, Argentina

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Viedma, Argentina

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Hobart, Australia

Research Site

Woolloongabba, Australia

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Edegem, Belgium

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Jette, Belgium

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Libramont-Chevigny, Belgium

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Liège, Belgium

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Mechelen, Belgium

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Roeselaere, Belgium

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Blumenau, Brazil

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Fortaleza, Brazil

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Ijuí, Brazil

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Itajaí, Brazil

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Londrina, Brazil

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Passo Fundo, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Porto Velho, Brazil

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Salvador, Brazil

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Salvador, Brazil

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Santo André, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Teresina, Brazil

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Burgas, Bulgaria

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Panagyurishte, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Edmonton, Alberta, Canada

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Kelowna, British Columbia, Canada

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Cambridge, Ontario, Canada

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Newmarket, Ontario, Canada

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Toronto, Ontario, Canada

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Québec, Quebec, Canada

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Saint-Jérôme, Quebec, Canada

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Conception, Chile

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Santiago, Chile

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Santiago, Chile

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Santiago, Chile

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Baoding, China

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Beijing, 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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Changchun, 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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Chongqing, China

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Fuzhou, China

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Fuzhou, China

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Guangzhou, China

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Haerbin, China

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Hangzhou, China

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Hefei, China

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Hefei, China

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Jiamusi, China

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Jinan, China

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Lanzhou, China

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Linyi, China

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Liuzhou, China

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Nanchang, China

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Nanchang, China

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Nanjing, China

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Nanjing, China

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Nanning, China

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Ningbo, China

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Qingdao, China

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Shanghai, China

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Shenyang, China

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Suzhou, China

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Taiyuan, China

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Wuhan, China

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Wuhan, China

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Xuzhou, China

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Yantai, China

Research Site

Zhengzhou, China

Research Site

Cali, Colombia

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Floridablanca, Colombia

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Medellín, Colombia

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Valledupar, Colombia

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San José, Costa Rica

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San José, Costa Rica

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San José Capital, Costa Rica

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Santa Ana, Costa Rica

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Angers, France

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Avignon, France

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Boulogne-Billancourt, France

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Caen, France

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Chambéry, France

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Dijon, France

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La Tronche, France

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Limoges, France

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Nantes, France

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Paris, France

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Pau, France

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St-Malo, France

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Toulouse, France

Research Site

Tbilisi, Georgia

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Tbilisi, Georgia

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Tbilisi, Georgia

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Tbilisi, Georgia

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Amberg, Germany

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Augsburg, by, Germany

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Bad Saarow, Germany

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Berlin, Germany

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Berlin, Germany

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Bonn, Germany

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Braunschweig, Germany

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Essen, Germany

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Flensburg, Germany

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Frankfurt am Main, Germany

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Hamburg, Germany

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Heidelberg, Germany

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Heilbronn, Germany

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Immenhausen, Germany

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Koblenz, Germany

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Leipzig, Germany

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München, Germany

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Offenbach, Germany

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Oldenburg, Germany

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Remscheid, Germany

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Rotenburg (Wümme), Germany

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Schweinfurt, Germany

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Trier, Germany

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Velbert, Germany

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Wuppertal, Germany

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Würselen, Germany

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Würzburg, Germany

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Athens, Greece

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Athens, Greece

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Athens, Greece

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Piraeus, Greece

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Piraeus, Greece

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Thessaloniki, Greece

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Thessaloniki, Greece

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Thessaloniki, Greece

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Thessaloniki, Greece

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Dublin, Ireland

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Dublin, Ireland

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Dublin, Ireland

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Dublin, Ireland

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Dublin, Ireland

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Galway, Ireland

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Afula, Israel

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Beersheba, Israel

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Hadera, Israel

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Haifa, Israel

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Haifa, Israel

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Jerusalem, Israel

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Jerusalem, Israel

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Ramat Gan, Israel

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Tel Aviv, Israel

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Tel Aviv, Israel

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Candiolo, Italy

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Lecco, Italy

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Lucca, Italy

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Meldola, Italy

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Milan, Italy

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Naples, Italy

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Peschiera del Garda, Italy

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Pisa, Italy

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Roma, Italy

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Torrette Di Ancona, Italy

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Udine, Italy

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Verona, Italy

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Akashi, Japan

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Bunkyō City, Japan

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Bunkyō City, Japan

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Fukuoka, Japan

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Fukuoka, Japan

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Hamamatsu, Japan

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Iwakuni-shi, Japan

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Izumi-shi, Japan

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Kashihara-shi, Japan

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Kobe, Japan

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Kōtoku, Japan

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Kurume-shi, Japan

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Kyoto, Japan

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Matsuyama, Japan

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Nankoku-shi, Japan

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Niigata, Japan

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Osaka, Japan

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Sakaishi, Japan

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Sayama, Japan

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Sendai, Japan

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Shinagawa-ku, Japan

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Takarazuka-shi, Japan

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Toon-Shi, Japan

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Toyoake-shi, Japan

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Toyonaka-shi, Japan

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George Town, Malaysia

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Kota Bharu, Malaysia

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Kuala Lumpur, Malaysia

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Kuala Selangor, Malaysia

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Perai, Malaysia

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Alcabideche, Portugal

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Braga, Portugal

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Coimbra, Portugal

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Lisbon, Portugal

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Lisbon, Portugal

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Lisbon, Portugal

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Loures, Portugal

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Matosinhos Municipality, Portugal

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Porto, Portugal

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Porto, Portugal

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Porto, Portugal

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Bucharest, Romania

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Bucharest, Romania

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Bucharest, Romania

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Bucharest, Romania

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Craiova, Romania

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Craiova, Romania

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Iași, Romania

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Otopeni, Romania

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Piteşti, Romania

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Sibiu, Romania

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Timișoara, Romania

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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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Badajoz, Spain

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Badalona, Spain

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Barcelona, Spain

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Castellon, Spain

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Granada, Spain

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Jaén, Spain

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Lugo, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Málaga, Spain

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Oviedo, Spain

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Palma de Mallorca, Spain

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Valencia, Spain

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Vigo (Pontevedra), Spain

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Zaragoza, Spain

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Lausanne, Switzerland

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Ankara, Turkey (Türkiye)

Research Site

Bakırköy, Turkey (Türkiye)

Research Site

Çankaya, Turkey (Türkiye)

Research Site

İzmit, Turkey (Türkiye)

Research Site

Küçükçekmece, Turkey (Türkiye)

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Yüreğir, Turkey (Türkiye)

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Blackpool, United Kingdom

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Glasgow, United Kingdom

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Guildford, United Kingdom

Research Site

Hull, United Kingdom

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Oxford, United Kingdom

Research Site

Stevenage, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06868277

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