Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations
NCT ID: NCT05687266
Last Updated: 2025-12-10
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
1350 participants
INTERVENTIONAL
2022-12-29
2027-11-01
Brief Summary
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Detailed Description
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The primary objectives of the study are to demonstrate superiority of Dato-DXd in combination with durvalumab and carboplatin relative to pembrolizumab in combination with platinum-based chemotherapy by assessment of the following:
1. PFS by BICR in first-line treatment of participants with non-squamous TROP2 biomarker positive locally-advanced or metastatic NSCLC
2. OS in first-line treatment of participants with non-squamous TROP2 biomarker positive locally-advanced or metastatic NSCLC
3. PFS by BICR in first-line treatment of participants with non-squamous locally-advanced or metastatic NSCLC
4. OS in first-line treatment of participants with non-squamous locally-advanced or metastatic NSCLC
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dato-DXd + Durvalumab + Carboplatin
Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 1120 mg durvalumab plus carboplatin area under the curve \[AUC\] 5 mg/mL/minute.
Datopotamab deruxtecan
Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Durvalumab
Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Carboplatin
Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Histologic-specific therapy
Non-squamous NSCLC participants will be randomized to receive 200 mg pembrolizumab plus 500 mg/m2 pemetrexed plus either AUC 5 mg/mL/minute carboplatin or 75 mg/m2 cisplatin.
Squamous NSCLC participants will be randomized to receive 200 mg of pembrolizumab plus 200 mg/m2 paclitaxel plus AUC 5 or 6 mg/mL/minute carboplatin.
Carboplatin
Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Pembrolizumab
Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle for a maximum of 35 cycles or 2 years (whichever occurs first).
Cisplatin
Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Pemetrexed
Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Paclitaxel
Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Interventions
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Datopotamab deruxtecan
Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Durvalumab
Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Carboplatin
Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Pembrolizumab
Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle for a maximum of 35 cycles or 2 years (whichever occurs first).
Cisplatin
Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Pemetrexed
Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Paclitaxel
Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically documented NSCLC that at the time of randomisation is Stage IIIB or IIIC disease not amenable to surgical resection or definitive chemoradiation or Stage IV metastatic disease
* Lacks sensitising EGFR tumour tissue mutation and ALK and ROS1 rearrangements and has no documented tumour genomic alterations in NTRK, BRAF, RET, MET or other actionable driver oncogenes with approved and available therapies (actionable genomic alterations).
Testing is not required for tumors with squamous histology, with exceptions.
* ECOG PS of 0 or 1
* Archival tumour tissue
* Has adequate bone marrow reserve and organ function within 7 days before randomization
Exclusion:
* Mixed small-cell lung cancer and NSCLC histology; sarcomatoid variant of NSCLC
* History of another primary malignancy with exceptions
* Persistent toxicities caused by previous anti-cancer therapy not yet improved to Grade ≤ 1 or baseline, with exceptions.
* Spinal cord compression or clinically or radiologically active brain metastases
* History of leptomeningeal carcinomatosis.
* Known active or uncontrolled hepatitis B or C virus infection.
* Uncontrolled or suspected infection requiring IV antibiotics, antivirals, or antifungals.
* Clinically significant corneal disease
* 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.
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Charu Aggarwal
Role: STUDY_CHAIR
Perelman Center for Advanced Medicine
Locations
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Hot Springs, Arkansas, United States
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Little Rock, Arkansas, United States
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Springdale, Arkansas, United States
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Fountain Valley, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Boulder, Colorado, United States
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Fort Myers, Florida, United States
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Jacksonville, 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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Hinsdale, Illinois, United States
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Fort Wayne, Indiana, United States
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Bettendorf, Iowa, United States
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Iowa City, Iowa, United States
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Waukee, Iowa, United States
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Baton Rouge, Louisiana, United States
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Covington, Louisiana, United States
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Duluth, Minnesota, United States
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Rochester, Minnesota, United States
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Hannibal, Missouri, United States
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Lincoln, Nebraska, United States
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Lincoln, Nebraska, United States
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Clifton Park, New York, United States
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Asheville, North Carolina, United States
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Canton, Ohio, United States
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Columbus, Ohio, United States
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Maumee, Ohio, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Salem, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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York, Pennsylvania, United States
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Watertown, South Dakota, United States
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Memphis, Tennessee, United States
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Dallas, Texas, 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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Irving, Texas, United States
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Fairfax, Virginia, United States
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Henrico, Virginia, United States
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Norfolk, Virginia, United States
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Renton, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Appleton, Wisconsin, United States
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La Crosse, Wisconsin, United States
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Graz, , Austria
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Rankweil, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Blumenau, , Brazil
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Florianópolis, , Brazil
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Fortaleza, , Brazil
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Londrina, , Brazil
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Porto Alegre, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Taubaté, , Brazil
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Vitória, , Brazil
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Saint John, New Brunswick, Canada
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Brampton, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Kitchener, Ontario, Canada
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Newmarket, Ontario, 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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Saint-Jérôme, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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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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Changsha, , 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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Guangzhou, , China
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Guangzhou, , China
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Hefei, , China
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Jinan, , China
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Kunming, , China
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Lanzhou, , China
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Liuchow, , China
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Shandong, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shantou, , China
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Shenyang, , China
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Shenzhen, , 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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Xiamen, , China
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Yangzhou, , China
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Zhengzhou, , China
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Brest, , France
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Créteil, , France
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Gleizé, , France
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Montpellier, , France
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Nîmes, , France
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Paris, , France
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Paris, , France
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Rouen, , France
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Saint-Quentin, , France
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Strasbourg, , France
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Toulon, , France
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Toulouse, , France
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Tours, , France
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Bad Berka, , Germany
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Berlin, , Germany
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Frankfurt A. Main, , Germany
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Gauting, , Germany
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Gütersloh, , Germany
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Hamburg, , Germany
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Kassel, , Germany
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Kiel, , Germany
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Koblenz, , Germany
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Minden, , Germany
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Rosenheim, , Germany
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Velbert, , Germany
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Würzburg, , Germany
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Piraeus, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Gyöngyös - Mátraháza, , Hungary
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Kaposvár, , Hungary
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Pécs, , Hungary
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Szekszárd, , Hungary
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Szolnok, , Hungary
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Törökbálint, , Hungary
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Calicut, , India
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Delhi, , India
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Delhi, , India
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Jaipur, , India
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Kolkata, , India
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Madurai, , India
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Puducherry, , India
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Florence, , Italy
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Lecco, , Italy
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Messina, , Italy
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Napoli, , Italy
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Orbassano, , Italy
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Padua, , Italy
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Parma, , Italy
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Peschiera del Garda, , Italy
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Rozzano, , Italy
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Bunkyō City, , Japan
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Chūōku, , Japan
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Hamamatsu, , Japan
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Hamamatsu, , Japan
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Hidaka-shi, , Japan
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Hirosaki-shi, , Japan
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Hiroshima, , Japan
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Kumamoto, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Osakasayama-shi, , Japan
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Sapporo, , Japan
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Sunto-gun, , Japan
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Wakayama, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Del. Cuauhtemoc, , Mexico
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Mexico City, , Mexico
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México, , Mexico
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San Luis Potosí City, , Mexico
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Arequipa, , Peru
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Concepción, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Bydgoszcz, , Poland
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Bystra, , Poland
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Grudziądz, , Poland
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Kielce, , Poland
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Koszalin, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Przemyśl, , Poland
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Racibórz, , Poland
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Radom, , Poland
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Siedlce, , Poland
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Busan, , South Korea
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Cheongju-si, , 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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Suwon, , South Korea
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Las Palmas de Gran Canaria, , Spain
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Lugo, , Spain
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Madrid, , Spain
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Santander, , Spain
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Seville, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Gävle, , Sweden
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Linköping, , Sweden
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Lund, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Hsinchu, , Taiwan
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Edirne, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Aberdeen, , United Kingdom
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Cambridge, , United Kingdom
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Cardiff, , United Kingdom
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Cheltenham, , United Kingdom
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Edinburgh, , United Kingdom
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London, , 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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Newcastle upon Tyne, , United Kingdom
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Taunton, , United Kingdom
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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Other Identifiers
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2021-004606-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D926NC00001
Identifier Type: -
Identifier Source: org_study_id
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