A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer
NCT ID: NCT06868277
Last Updated: 2026-01-13
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
830 participants
INTERVENTIONAL
2025-04-10
2030-12-02
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
Arm A : Rilvegostomig Arm B : Pembrolizumab
TREATMENT
QUADRUPLE
Study Groups
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Arm A
Drug: rilvegostomig
Rilvegostomig
Administered intravenously (IV) on Day 1 of each 21-day cycle
Arm B
Drug: Pembrolizumab
Pembrolizumab
Administered intravenously (IV) on Day 1 of each 21-day cycle
Interventions
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Rilvegostomig
Administered intravenously (IV) on Day 1 of each 21-day cycle
Pembrolizumab
Administered intravenously (IV) on Day 1 of each 21-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage IV mNSCLC (metastatic non-small cell lung cancer) (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
* Absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene 1) rearrangements. Negative assay result is required for all non-squamous histology subtypes.
* Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L (first line) therapies.
* WHO (World Health Organization)/ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1, with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomization.
* Minimum life expectancy of 12 weeks.
* Provision of acceptable tumor sample for the central testing prior to randomization.
* At least one lesion not previously irradiated that qualifies as a RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1) TL (target lesion) 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 CT (computed tomography) or MRI (magnetic resonance imaging) and is suitable for accurate repeated measurements.
* Adequate organ and bone marrow function
Exclusion Criteria
* History of organ transplant.
* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
* Presence of small cell and neuroendocrine histology components.
* Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 4 weeks prior to start of study intervention.
* Active primary immunodeficiency/active infectious disease(s)
* Active tuberculosis infection
* Any prior systemic therapy received for advanced or mNSCLC (metastatic non-small cell lung cancer).
* Any prior exposure to an anti-TIGIT (T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain) therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
* Any prior treatment with an anti-PD-1 (programmed cell death protein 1) or anti-PD-L1 (anti-programmed death-ligand 1) agent.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Bay Pines, Florida, United States
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Clearwater, Florida, United States
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St. Petersburg, Florida, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Decatur, Illinois, United States
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Des Moines, Iowa, United States
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Waterloo, Iowa, United States
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Leawood, Kansas, United States
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Lexington, Kentucky, United States
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Bethesda, Maryland, United States
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Frederick, Maryland, United States
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Silver Spring, Maryland, United States
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Towson, Maryland, United States
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Bridgeton, Missouri, United States
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Lincoln, Nebraska, United States
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Paramus, New Jersey, United States
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Buffalo, New York, United States
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East Syracuse, New York, United States
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Fresh Meadows, New York, United States
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Westbury, New York, United States
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Canton, Ohio, United States
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Fountain Hill, Pennsylvania, United States
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Kittanning, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Round Rock, Texas, United States
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Aberdeen, Washington, United States
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Charleston, West Virginia, United States
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Morgantown, West Virginia, United States
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CABA, , Argentina
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Córdoba, , Argentina
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Rosario, , Argentina
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Viedma, , Argentina
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Hobart, , Australia
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Woolloongabba, , Australia
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Edegem, , Belgium
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Jette, , Belgium
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Libramont-Chevigny, , Belgium
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Liège, , Belgium
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Mechelen, , Belgium
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Roeselaere, , Belgium
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Blumenau, , Brazil
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Fortaleza, , Brazil
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Ijuí, , Brazil
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Itajaí, , Brazil
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Londrina, , Brazil
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Passo Fundo, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Velho, , Brazil
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Salvador, , Brazil
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Salvador, , Brazil
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Santo André, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Teresina, , Brazil
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Burgas, , Bulgaria
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Panagyurishte, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Edmonton, Alberta, Canada
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Kelowna, British Columbia, Canada
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Cambridge, Ontario, Canada
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Newmarket, Ontario, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Conception, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Baoding, , China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Bengbu, , China
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Changchun, , China
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Changchun, , China
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Changsha, , China
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Changsha, , China
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Chengdu, , China
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Chongqing, , China
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Chongqing, , China
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Fuzhou, , China
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Fuzhou, , China
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Guangzhou, , China
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Haerbin, , China
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Hangzhou, , China
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Hefei, , China
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Hefei, , China
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Jiamusi, , China
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Jinan, , China
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Lanzhou, , China
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Linyi, , China
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Liuchow, , China
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Nanchang, , China
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Nanchang, , China
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Nanjing, , China
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Nanjing, , China
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Nanning, , China
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Ningbo, , China
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Qingdao, , China
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Shanghai, , China
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Shenyang, , China
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Suzhou, , China
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Taiyuan, , China
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Wuhan, , China
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Wuhan, , China
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Xuzhou, , China
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Yantai, , China
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Zhengzhou, , China
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Cali, , Colombia
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Floridablanca, , Colombia
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Medellín, , Colombia
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Valledupar, , Colombia
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San José, , Costa Rica
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San José, , Costa Rica
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Santa Ana, , Costa Rica
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Angers, , France
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Avignon, , France
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Boulogne-Billancourt, , France
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Caen, , France
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Chambéry, , France
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Dijon, , France
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La Tronche, , France
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Limoges, , France
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Nantes, , France
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Paris, , France
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Pau, , France
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St-Malo, , France
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Toulouse, , France
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Amberg, , Germany
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Augsburg, by, , Germany
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Bad Saarow, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bonn, , Germany
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Braunschweig, , Germany
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Essen, , Germany
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Flensburg, , Germany
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Frankfurt am Main, , Germany
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Heilbronn, , Germany
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Immenhausen, , Germany
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Koblenz, , Germany
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Leipzig, , Germany
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Mainz, , Germany
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München, , Germany
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Oldenburg, , Germany
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Rotenburg (Wümme), , Germany
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Schweinfurt, , Germany
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Trier, , Germany
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Velbert, , Germany
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Wuppertal, , Germany
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Würselen, , 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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Piraeus, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Galway, , Ireland
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Afula, , Israel
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Beersheba, , Israel
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Hadera, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Tel Aviv, , Israel
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Candiolo, , Italy
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Lecco, , Italy
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Lucca, , Italy
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Meldola, , Italy
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Milan, , Italy
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Napoli, , Italy
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Peschiera del Garda, , Italy
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Pisa, , Italy
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Roma, , Italy
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Udine, , Italy
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Verona, , Italy
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Akashi, , Japan
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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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Hamamatsu, , Japan
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Iwakuni-shi, , Japan
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Izumi-shi, , Japan
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Kashihara-shi, , Japan
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Kobe, , Japan
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Kōtoku, , Japan
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Kurume-shi, , Japan
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Kyoto, , Japan
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Matsuyama, , Japan
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Nankoku-shi, , Japan
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Niigata, , Japan
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Osaka, , Japan
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Sakaishi, , Japan
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Sayama, , Japan
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Sendai, , Japan
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Shinagawa-ku, , Japan
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Takarazuka-shi, , Japan
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Toon-Shi, , Japan
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Toyoake-shi, , Japan
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Toyonaka-shi, , Japan
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George Town, , Malaysia
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Kota Bharu, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Selangor, , Malaysia
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Perai, , Malaysia
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Alcabideche, , Portugal
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Braga, , Portugal
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Coimbra, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Loures, , Portugal
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Matosinhos Municipality, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Craiova, , Romania
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Craiova, , Romania
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Iași, , Romania
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Otopeni, , Romania
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Piteşti, , Romania
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Sibiu, , Romania
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Timișoara, , Romania
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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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Badajoz, , Spain
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Badalona, , Spain
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Barcelona, , Spain
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Castellon, , Spain
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Granada, , Spain
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Jaén, , Spain
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Lugo, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Oviedo, , Spain
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Palma de Mallorca, , Spain
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Valencia, , Spain
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Vigo (Pontevedra), , Spain
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Zaragoza, , Spain
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Lausanne, , Switzerland
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Ankara, , Turkey (Türkiye)
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Bakırköy, , Turkey (Türkiye)
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Çankaya, , Turkey (Türkiye)
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İzmit, , Turkey (Türkiye)
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Küçükçekmece, , Turkey (Türkiye)
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Yüreğir, , Turkey (Türkiye)
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Blackpool, , United Kingdom
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Glasgow, , United Kingdom
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Guildford, , United Kingdom
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Hull, , United Kingdom
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Stevenage, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2024-517780-24-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D702GC00001
Identifier Type: -
Identifier Source: org_study_id
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