A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.
NCT ID: NCT05984277
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1200 participants
INTERVENTIONAL
2023-10-24
2029-03-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Volrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
Volrustomig
Volrustomig
Carboplatin
Carboplatin
Paclitaxel
Paclitaxel
Pemetrexed
Pemetrexed
Arm 2
Pembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
Pembrolizumab
Pembrolizumab
Carboplatin
Carboplatin
Paclitaxel
Paclitaxel
Pemetrexed
Pemetrexed
Interventions
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Volrustomig
Volrustomig
Pembrolizumab
Pembrolizumab
Carboplatin
Carboplatin
Paclitaxel
Paclitaxel
Pemetrexed
Pemetrexed
Eligibility Criteria
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Inclusion Criteria
* Stage IV NSCLC (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology 2016), not amenable to curative surgery or radiation.
* Absence of sensitizing EGFR mutations and ALK and ROS1 rearrangements.
* Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted first-line therapies.
Exclusion Criteria
* Spinal cord compression.
* Symptomatic brain metastases. Brain metastases may be treated or untreated, but participants must be asymptomatic and off steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and study enrollment.
* History of another primary malignancy except for:
1. Malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
3. Adequately treated carcinoma in situ without evidence of disease.
* As judged by the investigator, any condition that would interfere with evaluation of the study intervention or interpretation of participant safety or study results.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Prescott, Arizona, United States
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Hot Springs, Arkansas, United States
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Springdale, Arkansas, United States
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Long Beach, California, United States
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Lone Tree, Colorado, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Orlando, Florida, United States
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St. Petersburg, Florida, United States
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West Palm Beach, Florida, United States
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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Des Moines, Iowa, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Silver Spring, Maryland, United States
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Towson, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Grand Island, Nebraska, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Albuquerque, New Mexico, United States
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East Syracuse, New York, United States
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Fresh Meadows, New York, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Portland, Oregon, United States
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Horsham, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Irving, Texas, United States
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Lancaster, Texas, United States
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Fairfax, Virginia, United States
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Tacoma, Washington, United States
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CABA, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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La Plata, , Argentina
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La Plata, , Argentina
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Rosario, , Argentina
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Clayton, , Australia
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Fitzroy, , Australia
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Heidelberg, , Australia
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South Brisbane, , Australia
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Sydney, , Australia
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Linz, , Austria
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Wels, , Austria
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Aalst, , Belgium
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Antwerp, , Belgium
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Ghent, , Belgium
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Barretos, , Brazil
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Curitiba, , Brazil
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Florianópolis, , Brazil
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Fortaleza, , Brazil
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Natal, , 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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Santa Cruz do Sul, , Brazil
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São Paulo, , Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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Barrie, Ontario, Canada
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Oshawa, Ontario, Canada
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Toronto, Ontario, Canada
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Lévis, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Chicoutimi, , Canada
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Changchun, , China
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Changsha, , China
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Chengdu, , China
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Chengdu, , China
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Chongqing, , China
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Fuzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Hefei, , China
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Lanzhou, , China
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Linhai, , China
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Linyi, , China
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Nanchang, , China
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Nanchang, , China
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Nanjing, , China
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Nanning, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shenzhen, , China
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Taiyuan, , China
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Tianjin, , China
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Wuhan, , China
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Wuhan, , China
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Wuhan, , China
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Xi'an, , China
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Yangzhou, , China
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Zhengzhou, , China
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Olomouc, , Czechia
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Ostrava - Vitkovice, , Czechia
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Prague, , Czechia
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Angers, , France
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Avignon, , France
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Bayonne, , France
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Bordeaux, , France
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Caen, , France
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Lille, , France
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Limoges, , France
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Marseille, , France
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Paris, , France
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Quimper, , France
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Reims, , France
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St-Malo, , France
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Strasbourg, , France
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Suresnes, , France
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Toulon Naval, , France
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Berlin-Zehlendorf, , Germany
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Bonn, , Germany
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Braunschweig, , Germany
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Dresden, , Germany
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Freiburg im Breisgau, , Germany
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Gauting, , Germany
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Georgsmarienhütte, , Germany
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Gütersloh, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Immenhausen, , Germany
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Koblenz, , Germany
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Ludwigsburg, , Germany
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Nuremberg, , Germany
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Tübingen, , Germany
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Velbert, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Gyöngyös, , Hungary
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Gyöngyös - Mátraháza, , Hungary
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Győr, , Hungary
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Pécs, , Hungary
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Szekszárd, , Hungary
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Törökbálint, , Hungary
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Bengaluru, , India
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Hyderabad, , India
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Kolkata, , India
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Mysuru, , India
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Nagpur, , India
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Nashik, , India
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Varanasi, , India
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Bari, , Italy
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Bergamo, , Italy
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Milan, , Italy
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Padua, , Italy
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Parma, , Italy
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Pavia, , Italy
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Ravenna, , Italy
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Roma, , Italy
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Bunkyō City, , Japan
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Fukuoka, , Japan
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Kashiwa, , Japan
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Kawasaki-shi, , Japan
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Kōtoku, , Japan
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Matsuyama, , Japan
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Nagoya, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Sagamihara-shi, , Japan
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Sakai, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Ube-shi, , Japan
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Yokohama, , Japan
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Amsterdam, , Netherlands
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Groningen, , Netherlands
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Nieuwegein, , Netherlands
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Tilburg, , Netherlands
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Lublin, , Poland
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Poznan, , Poland
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Przemyśl, , Poland
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Radom, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Trnava, , Slovakia
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eManzimtoti, , South Africa
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George, , South Africa
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Johannesburg, , South Africa
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Johannesburg, , South Africa
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Pietermaritzburg, , South Africa
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Pretoria, , South Africa
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Rondebosch, , South Africa
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Soweto, , South Africa
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Cheongju-si, , South Korea
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Daegu, , South Korea
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Incheon, , 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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Suwon, , South Korea
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Suwon, , South Korea
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Alicante, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Bilbao (Vizcaya), , Spain
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Madrid, , Spain
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Málaga, , Spain
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Palma, , 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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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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Taoyuan District, , Taiwan
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Yunlin, , Taiwan
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Bangkok, , Thailand
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Dusit, , Thailand
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Lampang, , Thailand
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Muang, , 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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Çankaya, , Turkey (Türkiye)
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Diyarbakır, , Turkey (Türkiye)
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Fatih-Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Pamukkale, , Turkey (Türkiye)
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Birmingham, , United Kingdom
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Blackpool, , United Kingdom
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Bury St Edmunds, , United Kingdom
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Colchester, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Truro, , United Kingdom
Countries
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Related Links
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Other Identifiers
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2023-000056-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D798AC00001
Identifier Type: -
Identifier Source: org_study_id