Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations
NCT ID: NCT07291037
Last Updated: 2025-12-18
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
400 participants
INTERVENTIONAL
2025-10-31
2029-01-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Arm B: Docetaxel monotherapy
TREATMENT
NONE
Study Groups
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Arm A: Datopotamab deruxtecan (Dato-DXd) monotherapy
Participants in the Dato-DXd monotherapy group will receive Dato-DXd as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Datopotamab deruxtecan (Dato-DXd)
Dato-DXd administered intravenously (IV)
Arm B: Docetaxel monotherapy
Participants in the docetaxel monotherapy group will receive docetaxel as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Docetaxel
Docetaxel administered intravenously (IV)
Interventions
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Datopotamab deruxtecan (Dato-DXd)
Dato-DXd administered intravenously (IV)
Docetaxel
Docetaxel administered intravenously (IV)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have documented negative test results for epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and ROS proto-oncogene 1 (ROS1) genomic alterations.
* Has no known tumour genomic alterations in neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET), mesenchymal-epithelial transition (MET) exon 14 skipping, Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C, human epidermal growth factor receptor 2 (HER2) or any other actionable driver oncogenes for which there are locally approved and available targeted first-line therapies.
* Prospectively assessed trophoblast cell surface protein 2 (TROP2) normalised membrane ratio (NMR) positive.
* Documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
* Participants must have received platinum based chemotherapy (PBC) in combination with anti-programmed death-protein 1 (anti-PD-1)/anti-programmed death-ligand 1 (anti-PD-L1) monoclonal antibody (mAb) as the only prior line of therapy or received PBC and anti-PD-1/anti-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy.
* Provision of acceptable formalin fixed and paraffin embedded (FFPE) tumour sample for assessment of TROP2.
* At least one lesion not previously irradiated that qualifies as a Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1) target lesion (TL) at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
* Adequate bone marrow reserve and organ function within 7 days before randomisation.
Exclusion Criteria
* NSCLC disease that is eligible for definitive local therapy alone.
* History of another primary malignancy other than NSCLC, except for malignancy treated with curative intent with no known active disease within 3 years before randomisation and of low potential risk for recurrence.
* Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring treatment with corticosteroids or anticonvulsants for at least 7 days prior to randomisation.
* Clinically significant corneal disease.
* Has active or uncontrolled hepatitis B or C virus infection.
* Known human immunodeficiency virus (HIV) infection that is not well controlled.
* Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
* History of non-infectious interstitial lung disease (ILD)/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
* Severe pulmonary function compromise per Investigator discretion.
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Chandler, Arizona, United States
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Gilbert, Arizona, United States
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Goodyear, Arizona, United States
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Duarte, California, United States
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Irvine, California, United States
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La Jolla, California, United States
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Loma Linda, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Grand Junction, Colorado, United States
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Wheat Ridge, 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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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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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Marietta, Georgia, United States
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Newnan, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Niles, Illinois, United States
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Zion, Illinois, United States
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Louisville, Kentucky, United States
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South Portland, Maine, United States
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Baltimore, Maryland, United States
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Brandywine, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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Bridgeton, Missouri, United States
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Columbia, Missouri, United States
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Lincoln, 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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Portland, Oregon, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Greenville, South Carolina, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Denton, Texas, United States
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Plano, Texas, United States
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Charlottesville, Virginia, United States
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Fairfax, Virginia, United States
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Williamsburg, Virginia, United States
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Tacoma, Washington, United States
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Morgantown, West Virginia, United States
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Eau Claire, Wisconsin, United States
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Gosford, , Australia
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Kogarah, , Australia
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South Brisbane, , Australia
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St Albans, , Australia
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Wollongong, , Australia
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Graz, , 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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Hasselt, , Belgium
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La Louvière, , Belgium
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Libramont-Chevigny, , Belgium
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Namur, , Belgium
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Sint-Niklaas, , Belgium
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Salvador, , 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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Vancouver, British Columbia, Canada
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Moncton, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Hamilton, Ontario, Canada
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Toronto, Ontario, 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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Harbin, , China
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Hefei, , China
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Jiamusi, , China
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Jinan, , China
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Nanchang, , China
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Nanjing, , 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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Tianjin, , China
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Wuhan, , China
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Wuhan, , China
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Xuzhou, , China
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Zhengzhou, , China
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Zhengzhou, , China
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Bad Saarow, , Germany
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Bielefeld, , Germany
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Bonn, , Germany
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Cologne, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Freiburg im Breisgau, , Germany
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Gauting, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Krefeld, , Germany
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Minden, , Germany
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Oldenburg, , Germany
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Troisdorf, , 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 - Mátraháza, , Hungary
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Győr, , Hungary
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Gyula, , Hungary
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Kecskemét, , Hungary
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Törökbálint, , Hungary
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Bangalore, , India
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Kolkata, , India
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Mumbai, , India
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Nashik, , India
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New Delhi, , India
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Milan, , Italy
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Milan, , Italy
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Monza, , Italy
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Orbassano, , Italy
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Padua, , Italy
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Rozzano, , Italy
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Chūōku, , Japan
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Fukuoka, , Japan
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Hiroshima, , Japan
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Iwakuni-shi, , Japan
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Kashiwa, , Japan
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Kawasaki-shi, , Japan
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Kyoto, , Japan
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Matsuyama, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Osaka, , Japan
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Osakasayama-shi, , Japan
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Sendai, , Japan
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Sunto-gun, , Japan
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Yokohama, , Japan
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Lodz, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Goyang-si, , South Korea
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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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Kaohsiung City, , Taiwan
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Taichung, , 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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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Hat Yai, , Thailand
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Muang, , Thailand
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Huddersfield, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Maidstone, , United Kingdom
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Norwich, , United Kingdom
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Hanoi, , 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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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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2024-520101-39-00
Identifier Type: OTHER
Identifier Source: secondary_id
D763QC00001
Identifier Type: -
Identifier Source: org_study_id