A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC
NCT ID: NCT06627647
Last Updated: 2025-12-22
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
878 participants
INTERVENTIONAL
2024-11-27
2030-03-25
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: Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.
TREATMENT
QUADRUPLE
Study Groups
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Arm A
Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.
Rilvegostomig
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Carboplatin
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Cisplatin
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Pemetrexed
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Arm B
Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.
Pembrolizumab
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Carboplatin
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Cisplatin
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Pemetrexed
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Interventions
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Rilvegostomig
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Pembrolizumab
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Carboplatin
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Cisplatin
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Pemetrexed
Administered as one 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 (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
* Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements.
* 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 therapies.
* Provision of acceptable tumor sample, to confirm tumor PD-L1 expression TC ≥ 1%.
* At least one lesion not previously irradiated that qualifies as a RECIST 1.1 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 CT or MRI and is suitable for accurate repeated measurements.
* Adequate organ and bone marrow function
Exclusion Criteria
* Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.
* Any prior systemic therapy received for advanced or mNSCLC. Prior systemic therapy in the neoadjuvant or adjuvant setting and/or definitive radio- or chemoradiotherapy for early-stage disease are allowed, provided that recurrence or progression has occurred \> 12 months after the end of treatment.
* Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
* Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
* 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.
* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
* Active primary immunodeficiency/active infectious disease(s).
* Active tuberculosis infection.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Mobile, Alabama, United States
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Chandler, Arizona, United States
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Phoenix, Arizona, United States
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Anaheim, California, United States
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Beverly Hills, California, United States
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Loma Linda, California, United States
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Redlands, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Santa Rosa, California, United States
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Walnut Creek, California, United States
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Lone Tree, Colorado, United States
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Stamford, Connecticut, United States
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West Haven, Connecticut, United States
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Newark, Delaware, United States
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Bay Pines, Florida, United States
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Fort Lauderdale, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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St. Petersburg, Florida, United States
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Atlanta, Georgia, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Decatur, Illinois, United States
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Hinsdale, Illinois, United States
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Quincy, Illinois, United States
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Rockford, Illinois, United States
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Waterloo, Iowa, United States
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Lexington, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Alexandria, Louisiana, United States
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Baton Rouge, Louisiana, United States
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Shreveport, Louisiana, United States
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Shreveport, Louisiana, United States
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South Portland, Maine, United States
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Baltimore, Maryland, United States
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Grand Rapids, Michigan, United States
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Duluth, Minnesota, United States
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Rochester, Minnesota, United States
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Saint Paul, 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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Camden, New Jersey, United States
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Buffalo, 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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Medford, Oregon, United States
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Portland, Oregon, United States
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Salem, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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York, Pennsylvania, United States
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Providence, Rhode Island, United States
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Pierre, South Dakota, United States
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Sioux Falls, South Dakota, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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Kingwood, Texas, United States
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Lubbock, Texas, United States
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Palestine, Texas, United States
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Round Rock, Texas, United States
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Fairfax, Virginia, United States
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Norfolk, Virginia, United States
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Roanoke, Virginia, 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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Spokane, Washington, United States
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Tacoma, Washington, United States
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Wenatchee, Washington, United States
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La Crosse, Wisconsin, United States
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Buenos Aires, , Argentina
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CABA, , Argentina
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La Plata, , Argentina
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Pilar, , Argentina
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Rosario, , Argentina
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Darlinghurst, , Australia
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Hyde Park, , Australia
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Southport, , Australia
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Wollongong, , Australia
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Brussels, , Belgium
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Charleroi, , Belgium
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Kortrijk, , Belgium
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Ottignies, , Belgium
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Sint-Niklaas, , Belgium
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Ijuí, , 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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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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Taubaté, , Brazil
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Vitória, , Brazil
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Saint John, New Brunswick, Canada
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Sydney, Nova Scotia, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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Sault Ste. Marie, Ontario, 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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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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Chongqing, , China
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Fuzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Harbin, , China
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Hefei, , China
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Jinan, , China
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Jingzhou, , China
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Kunming, , China
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Linhai, , China
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Nanchang, , China
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Ningbo, , China
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Shanghai, , China
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Shanghai, , China
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Wenzhou, , China
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Wuhan, , China
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Xi'an, , China
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Xiangyang, , China
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Zhengzhou, , China
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Zhengzhou, , China
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Avignon, , France
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La Rochelle, , France
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Lyon, , France
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Nîmes, , France
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Rennes, , France
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Strasbourg, , France
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Suresnes, , France
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Toulon, , France
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Bad Berka, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Esslingen am Neckar, , Germany
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Frankfurt, , Germany
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Gauting, , Germany
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Giessen, , Germany
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Großhansdorf, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Hanover, , Germany
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Hemer, , Germany
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Homburg, , Germany
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Kassel, , Germany
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Kiel, , Germany
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Krefeld, , Germany
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Minden, , Germany
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Moers, , Germany
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München, , Germany
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Regensburg, , Germany
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Würzburg, , 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, , Hungary
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Gyöngyös - Mátraháza, , Hungary
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Győr, , Hungary
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Pécs, , Hungary
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Székesfehérvár, , Hungary
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Törökbálint, , Hungary
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Calicut, , India
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Delhi, , India
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Kolkata, , India
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Madurai, , India
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Mumbai, , India
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Nashik, , India
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New Delhi, , India
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Varanasi, , India
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Florence, , Italy
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Monza, , Italy
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Peschiera del Garda, , Italy
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Rome, , Italy
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Amagasaki-shi, , Japan
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Bunkyō City, , Japan
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Chūōku, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Hiroshima, , Japan
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Kawagoe-shi, , Japan
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Kawasaki-shi, , Japan
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Kitaadachi-gun, , Japan
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Kitakyushu-shi, , Japan
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Kobe, , Japan
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Kōtoku, , Japan
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Kumamoto, , Japan
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Kumamoto, , Japan
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Matsusaka-shi, , Japan
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Osaka, , Japan
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Ota-shi, , Japan
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Saitama-shi, , Japan
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Sendai, , Japan
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Shinjuku-ku, , Japan
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Sunto-gun, , Japan
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Takaoka-shi, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Kuala Lumpur, , Malaysia
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Kuching, , Malaysia
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Petaling Jaya, , Malaysia
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Alkmaar, , Netherlands
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Ede, , Netherlands
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Groningen, , Netherlands
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Leidschendam, , Netherlands
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Veldhoven, , Netherlands
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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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Bialystok, , Poland
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Biała Podlaska, , Poland
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Bydgoszcz, , Poland
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Bystra, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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San Juan, , Puerto Rico
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San Juan, , Puerto Rico
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Gyeonggi-do, , 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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Songpa-gu, , South Korea
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Barcelona, , Spain
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Castellon, , Spain
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Las Palmas de Gran Canaria, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Majadahonda, , Spain
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Seville, , Spain
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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New Taipei City, , Taiwan
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Dusit, , Thailand
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Nakhon Ratchasima, , Thailand
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Songkhla, , Thailand
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Edirne, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Seyhan, , Turkey (Türkiye)
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Aberdeen, , United Kingdom
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Cambridge, , United Kingdom
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Edinburgh, , United Kingdom
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Exeter, , United Kingdom
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Greater London, , 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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Newcastle upon Tyne, , United Kingdom
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Torquay, , United Kingdom
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Can Tho, , Vietnam
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Hanoi, , 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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2024-515008-38-00
Identifier Type: OTHER
Identifier Source: secondary_id
D702FC00001
Identifier Type: -
Identifier Source: org_study_id