A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features
NCT ID: NCT06564844
Last Updated: 2025-10-14
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
660 participants
INTERVENTIONAL
2024-10-15
2035-01-19
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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Dato-DXd + rilvegostomig
Participants in the Dato-DXd in combination with rilvegostomig group will receive Dato-DXd and rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W).
Datopotamab Deruxtecan
Datopotamab Deruxtecan IV (intravenous)
Rilvegostomig
Rilvegostomig IV (intravenous)
Rilvegostomig
Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W).
Rilvegostomig
Rilvegostomig IV (intravenous)
Standard of Care (SoC)
Patients in SoC group will undergo observation or will receive Investigator's Choice of Chemotherapy (ICC).
Carboplatin
Carboplatin IV (intravenous), Active Comparator
Cisplatin
Cisplatin IV (intravenous), Active Comparator
Etoposide
Etoposide IV (intravenous), Active Comparator
Pemetrexed
Pemetrexed IV (intravenous), Active Comparator
Vinorelbine
Vinorelbine IV (intravenous), Active Comparator
UFT
UFT Oral route of administration, Active Comparator
Interventions
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Datopotamab Deruxtecan
Datopotamab Deruxtecan IV (intravenous)
Rilvegostomig
Rilvegostomig IV (intravenous)
Carboplatin
Carboplatin IV (intravenous), Active Comparator
Cisplatin
Cisplatin IV (intravenous), Active Comparator
Etoposide
Etoposide IV (intravenous), Active Comparator
Pemetrexed
Pemetrexed IV (intravenous), Active Comparator
Vinorelbine
Vinorelbine IV (intravenous), Active Comparator
UFT
UFT Oral route of administration, Active Comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Complete surgical resection (R0) of the primary NSCLC
3. Unequivocal no evidence of disease at post-surgical
4. Pre-surgical ctDNA-positive result (Stage IA or IB) OR presence of at least one high-risk pathological feature (visceral pleural invasion (VPI), lymphovascular invasion (LVI), high-grade histology) (Stage IB only)
5. ECOG of 0 or 1, life expectancy of \> 6 months and complete recovery after surgery
6. Adequate bone marrow reserve and organ function
Exclusion Criteria
2. 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
3. Significant pulmonary function compromise
4. History of another primary malignancy within 3 years (with exceptions)
5. Any evidence of severe or uncontrolled systemic diseases, including but not limited to bleeding diseases, active infection and cardiac disease
6. Active or prior documented autoimmune or inflammatory disorders (with exceptions)
7. Active infection with tuberculosis, hepatitis B or C virus, hepatitis A, or known HIV infection that is not well controlled
8. History of active primary immunodeficiency
9. Clinically significant corneal disease
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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David Jones, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center, New York, United States of America
Enriqueta Felip, MD
Role: PRINCIPAL_INVESTIGATOR
Vall d'Hebron Hospital, Barcelona, Spain
Locations
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Gilbert, Arizona, United States
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Phoenix, Arizona, United States
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Prescott, Arizona, United States
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Tucson, Arizona, United States
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Duarte, California, United States
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Fountain Valley, California, United States
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Glendale, California, United States
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Irvine, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Orange, California, United States
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San Diego, California, United States
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Santa Barbara, California, United States
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Aurora, Colorado, United States
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Lone Tree, Colorado, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Washington D.C., District of Columbia, United States
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Washington D.C., District of Columbia, United States
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Clermont, Florida, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Miami, 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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St. Petersburg, 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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Boise, Idaho, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Zion, Illinois, United States
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Fort Wayne, Indiana, United States
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Kansas City, Kansas, United States
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Lexington, Kentucky, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Frederick, Maryland, United States
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Silver Spring, 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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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Dearborn, Michigan, United States
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Detroit, 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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Ypsilanti, Michigan, United States
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Duluth, Minnesota, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Camden, New Jersey, United States
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East Syracuse, New York, United States
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Mineola, New York, 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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New York, New York, United States
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The Bronx, New York, United States
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White Plains, New York, United States
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Durham, North Carolina, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Independence, Ohio, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Bethlehem, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Webster, Texas, United States
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Salt Lake City, Utah, United States
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Fairfax, Virginia, United States
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Fairfax, Virginia, United States
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Norfolk, Virginia, United States
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Edmonds, Washington, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Silverdale, Washington, United States
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Vancouver, Washington, United States
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Madison, Wisconsin, United States
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Camperdown, , Australia
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Murdoch, , Australia
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Townsville, , Australia
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Edegem, , Belgium
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Hasselt, , Belgium
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Barretos, , Brazil
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Brasília, , Brazil
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Florianópolis, , Brazil
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São Paulo, , Brazil
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Teresina, , Brazil
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Newmarket, Ontario, Canada
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Oshawa, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Angers, , France
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Marseille, , France
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Paris, , France
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Rouen, , France
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Suresnes, , France
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Toulon, , France
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Bonn, , Germany
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Erfurt, , Germany
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Essen, , Germany
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Esslingen am Neckar, , Germany
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Gauting, , Germany
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Georgsmarienhütte, , Germany
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Gera, , Germany
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Giessen, , Germany
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Karlsruhe, , Germany
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Kempten, , Germany
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Lübeck, , Germany
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Münster, , Germany
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Würzburg, , Germany
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Hong Kong, , Hong Kong
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Hong Kong, , Hong Kong
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Budapest, , Hungary
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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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Deszk, , Hungary
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Gyöngyös - Mátraháza, , Hungary
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Pécs, , Hungary
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Törökbálint, , Hungary
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Zalaegerszeg, , Hungary
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Florence, , Italy
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Monza, , Italy
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Padua, , Italy
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Roma, , Italy
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Roma, , Italy
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Rozzano, , Italy
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Bunkyō City, , Japan
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Chiba, , Japan
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Chūōku, , Japan
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Fukuoka, , Japan
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Hidaka-shi, , Japan
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Hiroshima, , Japan
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Hiroshima, , Japan
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Iwakuni-shi, , Japan
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Kashiwa, , Japan
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Kitaadachi-gun, , Japan
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Kobe, , Japan
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Kōtoku, , Japan
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Kumamoto, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Osakasayama-shi, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Sendai, , Japan
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Wakayama, , Japan
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Yokohama, , Japan
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George Town, , Malaysia
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Kuala Lumpur, , 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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Rotterdam, , Netherlands
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Olsztyn, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Alicante, , Spain
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Badalona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Zaragoza, , Spain
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Solna, , Sweden
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Zurich, , Switzerland
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Kaohsiung City, , 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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Bangkoknoi, , Thailand
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Banphaeo, , Thailand
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Dusit, , Thailand
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Hat Yai, , Thailand
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Muang, , Thailand
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Muang, , Thailand
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Ratchathewi, , Thailand
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Leeds, , United Kingdom
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London, , United Kingdom
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Nottingham, , 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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Vinh, , Vietnam
Countries
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Central Contacts
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Other Identifiers
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2024-512195-35-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D926TC00001
Identifier Type: -
Identifier Source: org_study_id
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