RecruitingPhase 3NCT06417814

A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants With EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Has Progressed on Prior Osimertinib Treatment (TROPION-Lung15)

Sponsor

AstraZeneca

Enrollment

744 participants

Start Date

Oct 4, 2024

Study Type

INTERVENTIONAL

Summary

This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).

Eligibility

Min Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new drug combination — datopotamab deruxtecan (Dato-DXd), an antibody-drug conjugate, with or without osimertinib — against standard platinum-based chemotherapy in people with advanced lung cancer (NSCLC) whose cancer progressed while on osimertinib. It targets tumors with EGFR mutations. **You may be eligible if...** - You have advanced non-squamous NSCLC confirmed by biopsy - Your tumor has a known EGFR mutation (such as Exon 19 deletion, L858R, or others associated with EGFR sensitivity) - Your cancer progressed after osimertinib treatment (most recent treatment line) - You have had no more than 2 prior EGFR-targeted drugs (osimertinib must be the only third-generation drug) - You have at least one measurable tumor on scans that has not been previously irradiated - Your general health is good (ECOG 0 or 1) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have received chemotherapy, immunotherapy, or other anti-cancer therapies for metastatic disease - You had platinum-based chemotherapy within 12 months prior to enrolling (in a non-metastatic setting) - You have another active primary cancer 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

DRUGDato-DXd

Dato-DXd will be administered as IV infusion.

DRUGOsimertinib

Osimertinib will be administered orally.

DRUGPemetrexed

Pemetrexed will be administered as IV infusion.

DRUGCarboplatin

Carboplatin will be administered as IV infusion.

DRUGCisplatin

Cisplatin will be administered as IV infusion.

Locations(302)

Research Site

Fayetteville, Arkansas, United States

Research Site

Duarte, California, United States

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Fountain Valley, California, United States

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La Jolla, 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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Colorado Springs, Colorado, United States

Research Site

Fort Collins, Colorado, 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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Chicago, Illinois, United States

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Evanston, Illinois, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Kansas City, Missouri, United States

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Omaha, Nebraska, United States

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Morristown, New Jersey, United States

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Northfield, New Jersey, United States

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New York, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Maumee, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Chattanooga, Tennessee, United States

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Nashville, Tennessee, United States

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Fairfax, Virginia, United States

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Seattle, Washington, United States

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Fitzroy, Australia

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Heidelberg, Australia

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Kogarah, Australia

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Liverpool, Australia

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Nedlands, Australia

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Port Macquarie, Australia

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St Leonards, Australia

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Westmead, Australia

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Woodville, Australia

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Woolloongabba, Australia

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Charleroi, Belgium

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Edegem, Belgium

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Ghent, Belgium

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Hasselt, Belgium

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Jette, Belgium

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La Louvière, Belgium

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Leuven, Belgium

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Namur, Belgium

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Roeselare, Belgium

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Barretos, Brazil

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Betim, Brazil

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Blumenau, Brazil

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Florianópolis, Brazil

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Itajaí, Brazil

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Pelotas, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Rio de Janeiro, Brazil

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Rio de Janeiro, Brazil

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Rio de Janeiro, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Brampton, Ontario, Canada

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Newmarket, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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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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Beijing, 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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Chengdu, China

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Deyang, China

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Ganzhou, China

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Guangzhou, China

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Hangzhou, China

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Hangzhou, China

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Hefei, China

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Hengyang, China

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Huaian, China

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Jinan, China

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Linyi, China

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Luoyang, China

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Luzhou, China

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Nanchang, China

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Nanjing, China

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Shanghai, China

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Shantou, China

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Shenyang, China

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Shenyang, China

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Tianjin, China

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Tianjin, China

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Weifang, China

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Wuhan, China

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Zhengzhou, China

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Zhengzhou, China

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Zhengzhou, China

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Angers, France

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Avignon, France

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Bordeaux, France

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Caen, France

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Lille, France

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Montpellier, France

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Nantes, France

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Paris, France

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Paris, France

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Pessac, France

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Quimper, France

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Toulon Armees, France

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Toulouse, France

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Tours, France

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Villejuif, France

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Berlin, Germany

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Berlin-Zehlendorf, Germany

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Bonn, Germany

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Essen, Germany

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Georgsmarienhütte, Germany

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Giessen, Germany

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Großhansdorf, Germany

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Hamburg, Germany

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Hamburg, Germany

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Heidelberg, Germany

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Kempten, Germany

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Löwenstein, Germany

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Nuremberg, Germany

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Oldenburg, Germany

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Athens, Greece

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Athens, Greece

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Athens, Greece

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Athens, Greece

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Heraklion, 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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Hong Kong, Hong Kong

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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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Shatin, Hong Kong

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Amravati, India

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Bhubaneswar, India

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Hyderabad, India

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Kolhāpur, India

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Mumbai, India

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Mysuru, India

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Namakkal, India

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Pune, India

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Raipur, India

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Rajasthan, India

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Ranchi, India

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Thane, India

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Trivandrum, India

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Varanasi, India

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Beersheba, 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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Kfar Saba, Israel

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Petah Tikva, Israel

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Ramat Gan, Israel

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Tel Aviv, Israel

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Bari, Italy

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Milan, Italy

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Misterbianco, Italy

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Monza, Italy

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Naples, Italy

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Orbassano, Italy

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Padova, Italy

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Parma, Italy

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Perugia, Italy

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Roma, Italy

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Rozzano, Italy

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Verona, Italy

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Bunkyō City, Japan

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Bunkyō City, Japan

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Fukuoka, Japan

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Hiroshima, Japan

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Iruma-Gun, Japan

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Iwakuni-shi, Japan

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Kobe, Japan

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Kōtoku, Japan

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Kumamoto, Japan

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Kyoto, Japan

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Matsuyama, Japan

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Nagoya, Japan

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Nagoya, Japan

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Niigata, Japan

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Osaka, Japan

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Osaka, Japan

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Ōsaka-sayama, Japan

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Sendai, Japan

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Sunto-gun, Japan

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Toyoake-shi, Japan

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Utsunomiya, Japan

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Wakayama, Japan

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Yokohama, Japan

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Yokohama, Japan

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Alor Star, Malaysia

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Cheras, Malaysia

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Johor Bahru, Malaysia

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Kuala Lumpur, Malaysia

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Kuala Selangor, Malaysia

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Kuching, Malaysia

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Perai, Malaysia

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Petaling Jaya, Malaysia

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Amersfoort, Netherlands

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Harderwijk, Netherlands

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Rotterdam, Netherlands

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Zutphen, Netherlands

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Bacolod, Philippines

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Cebu City, Philippines

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Davao City, Philippines

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Manila, Philippines

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Quezon, Philippines

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Quezon, Philippines

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San Juan City, Philippines

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Katowice, Poland

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Krakow, Poland

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Lodz, Poland

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Olsztyn, Poland

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Poznan, Poland

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Braga, Portugal

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Lisbon, Portugal

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Loures, Portugal

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Porto, Portugal

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Porto, Portugal

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Craiova, Romania

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Craiova, Romania

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Singapore, Singapore

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Singapore, Singapore

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Singapore, Singapore

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Busan, South Korea

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Chungcheongbuk-do, South Korea

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Goyang-si, South Korea

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Gyeonggi-do, South Korea

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Jinju, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Suwon, South Korea

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A Coruña, Spain

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Barakaldo, Spain

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Barcelona, Spain

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Barcelona, Spain

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El Palmar, Spain

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L'Hospitalet de Llobregat, Spain

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Madrid, Spain

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Madrid, Spain

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Majadahonda, Spain

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Málaga, Spain

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Oviedo, Spain

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Palma de Mallorca, Spain

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Pamplona, Spain

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Santander, Spain

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Santiago de Compostela-Coruña, Spain

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Seville, Spain

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Valencia, Spain

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Valencia, Spain

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Valladolid, Spain

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Changhua, Taiwan

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Kaohsiung 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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Tainan, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Bangkok, Thailand

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Bangkok, Thailand

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Bangkok, Thailand

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Chiang Mai, Thailand

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Hat Yai, Thailand

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Khon Kaen, Thailand

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Pathum Thani, Thailand

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Birmingham, United Kingdom

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Cambridge, United Kingdom

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Glasgow, United Kingdom

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Leicester, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Middlesbrough, United Kingdom

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Hanoi, Vietnam

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NCT06417814