Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
NCT ID: NCT06357533
Last Updated: 2025-10-27
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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RECRUITING
PHASE3
675 participants
INTERVENTIONAL
2024-04-11
2030-05-24
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
SINGLE
Study Groups
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Arm 1: Datopotamab Deruxtecan in Combination With Rilvegostomig
Participants in the Datopotamab Deruxtecan (Dato-DXd) in combination with Rilvegostomig group will receive Dato-DXd plus rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Datopotamab Deruxtecan
Datopotamab Deruxtecan IV (intravenous)
Rilvegostomig
Rilvegostomig IV (intravenous)
Arm 2: Rilvegostomig Monotherapy
Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Rilvegostomig
Rilvegostomig IV (intravenous)
Arm 3: Pembrolizumab Monotherapy
Participants in the pembrolizumab group will receive pembrolizumab as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Pembrolizumab
Pembrolizumab IV (intravenous)
Interventions
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Datopotamab Deruxtecan
Datopotamab Deruxtecan IV (intravenous)
Rilvegostomig
Rilvegostomig IV (intravenous)
Pembrolizumab
Pembrolizumab IV (intravenous)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation.
* Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies.
* Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers.
* Known tumour PD-L1 expression status defined as TC ≥ 50%
* At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline
* ECOG performance status of 0 or 1
* Adequate bone marrow reserve and organ function within 7 days before the first dose of study intervention
Exclusion Criteria
* Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant.
* History of another primary malignancy within 3 years
* Active or prior documented autoimmune or inflammatory disorders (with exceptions)
* Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease.
* Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage.
* History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
* Has significant pulmonary function compromise, as determined by the investigator
* Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants.
* History of leptomeningeal carcinomatosis
* Known clinically significant corneal disease
* Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled
* History of active primary immunodeficiency
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Suresh S. Ramalingam, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University, Atlanta, Georgia, United States of America.
Locations
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Anchorage, Alaska, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, 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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Fountain Valley, California, United States
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Newport Beach, California, United States
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Clermont, Florida, United States
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Gainesville, Florida, United States
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Miami Beach, Florida, United States
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Orange City, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Hinsdale, Illinois, United States
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Noblesville, Indiana, United States
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Annapolis, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Dearborn, Michigan, United States
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Farmington Hills, Michigan, United States
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Grand Rapids, Michigan, United States
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Traverse City, Michigan, United States
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Hattiesburg, Mississippi, United States
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Kansas City, Missouri, United States
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Bozeman, Montana, United States
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Grand Island, Nebraska, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Voorhees Township, New Jersey, United States
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Stony Brook, New York, United States
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Greenville, North Carolina, United States
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Salisbury, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Perrysburg, Ohio, United States
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Portland, Oregon, United States
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Greenville, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Chattanooga, Tennessee, United States
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Knoxville, Tennessee, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Kingwood, Texas, United States
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Odessa, Texas, United States
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Fort Belvoir, Virginia, United States
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Leesburg, Virginia, United States
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Richmond, Virginia, United States
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Tacoma, Washington, United States
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Vancouver, Washington, United States
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Wenatchee, Washington, United States
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Birtinya, , Australia
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Blacktown, , Australia
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Clayton, , Australia
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Gosford, , Australia
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Melbourne, , Australia
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South Brisbane, , Australia
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Southport, , Australia
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Wodonga, , Australia
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Innsbruck, , Austria
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Krems, , Austria
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Linz, , Austria
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Rankweil, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Wels, , Austria
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Anderlecht, , Belgium
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Hasselt, , Belgium
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La Louvière, , Belgium
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Liège, , Belgium
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Barretos, , Brazil
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Curitiba, , Brazil
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Florianópolis, , Brazil
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Ipatinga, , Brazil
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Natal, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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Santa Maria, , Brazil
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São Paulo, , Brazil
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Taubaté, , Brazil
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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London, Ontario, Canada
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Newmarket, 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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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Rimouski, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Chicoutimi, , Canada
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Beijing, , China
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Beijing, , 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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Harbin, , China
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Hefei, , China
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Hefei, , China
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Jinan, , China
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Jining, , China
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Kunming, , China
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Lanzhou, , China
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Linhai, , China
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Linyi, , China
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Nanjing, , China
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Nanning, , 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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Shenyang, , 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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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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Zhengzhou, , China
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Berlin, , Germany
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Bonn, , Germany
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Düsseldorf, , Germany
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Essen, , 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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Gera, , Germany
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Gütersloh, , 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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Koblenz, , Germany
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Ludwigsburg, , Germany
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München, , Germany
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Nuremberg, , Germany
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Potsdam, , Germany
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Ravensburg, , Germany
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Budapest, , Hungary
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Gyöngyös, , Hungary
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Gyöngyös - Mátraháza, , Hungary
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Győr, , Hungary
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Gyula, , Hungary
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Kecskemét, , Hungary
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Salgótarján, , Hungary
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Szekszárd, , Hungary
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Székesfehérvár, , Hungary
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Törökbálint, , Hungary
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Chennai, , India
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Dwārka, , India
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Jaipur, , India
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Kolkata, , India
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Marg Jaipur, , India
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Nagpur, , India
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Nashik, , India
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New Delhi, , India
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New Delhi, , India
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Thiruvananthapuram, , India
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Bergamo, , Italy
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Genoa, , Italy
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Milan, , Italy
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Milan, , Italy
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Monza, , Italy
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Padua, , Italy
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Pavia, , Italy
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Ravenna, , Italy
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Roma, , Italy
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Rozzano, , 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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Fukuoka, , Japan
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Hidaka-shi, , Japan
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Hirakata-shi, , Japan
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Hirosaki-shi, , Japan
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Hiroshima, , Japan
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Kanazawa, , Japan
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Kashiwa, , Japan
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Kawasaki-shi, , Japan
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Kumamoto, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Osakasayama-shi, , Japan
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Sagamihara-shi, , Japan
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Sapporo, , Japan
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Takaoka-shi, , Japan
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Takatsuki-shi, , Japan
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Tokushima, , Japan
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Tokyo, , Japan
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Utsunomiya, , Japan
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Yokohama, , Japan
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Olsztyn, , Poland
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Poznan, , Poland
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Przemyśl, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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San Juan, , Puerto Rico
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Changwon, , South Korea
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Incheon, , South Korea
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Seongnam-si, , 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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Jerez de la Frontera, , Spain
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Reus,Tarragona, , Spain
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Salamanca, , Spain
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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 City, , Taiwan
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Taipei, , 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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Bangkok, , Thailand
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Hat Yai, , Thailand
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Muang, , Thailand
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Mueang, , Thailand
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Mueang, , Thailand
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Adapazarı, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Diyarbakır, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Cheltenham, , United Kingdom
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Inverness, , 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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Preston, , United Kingdom
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Truro, , United Kingdom
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Da Nang, , Vietnam
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Hanoi, , Vietnam
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Hà Nội, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
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Huế, , Vietnam
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Vinh, , Vietnam
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Vĩnh Yên, , Vietnam
Countries
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Central Contacts
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Other Identifiers
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2023-505077-32-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D7632C00001
Identifier Type: -
Identifier Source: org_study_id
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