A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
NCT ID: NCT06692738
Last Updated: 2025-12-24
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
880 participants
INTERVENTIONAL
2024-11-18
2029-10-08
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 carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab
TREATMENT
QUADRUPLE
Study Groups
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Arm A
Rilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig
Rilvegostomig
Administered intravenously (IV) on Day 1 of each 21-day cycle
Carboplatin
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Paclitaxel
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Nab-paclitaxel
Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles
Arm B
Pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab
Pembrolizumab
Administered intravenously (IV) on Day 1 of each 21-day cycle
Carboplatin
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Paclitaxel
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Nab-paclitaxel
Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles
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
Carboplatin
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Paclitaxel
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Nab-paclitaxel
Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles
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 documented tumor genomic mutation results from tests conducted as part of standard local practice in any 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.
* Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
* Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
* 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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Tucson, Arizona, United States
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Springdale, Arkansas, 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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Los Alamitos, California, United States
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Redlands, California, United States
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San Francisco, California, United States
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Walnut Creek, California, 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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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Athens, Georgia, 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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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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Covington, 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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Bethesda, Maryland, United States
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Detroit, Michigan, 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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Bridgeton, Missouri, United States
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Columbia, Missouri, United States
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Kansas City, 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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East Syracuse, New York, United States
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Westbury, New York, United States
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Grand Forks, North Dakota, United States
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Cincinnati, Ohio, United States
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Bend, Oregon, United States
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Medford, Oregon, United States
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Salem, Oregon, United States
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Hershey, Pennsylvania, United States
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York, Pennsylvania, 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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Kingwood, Texas, United States
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Lubbock, Texas, United States
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Round Rock, Texas, United States
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Fairfax, Virginia, United States
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Fredericksburg, Virginia, United States
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Olympia, 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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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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Innsbruck, , Austria
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Krems, , Austria
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Rankweil, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Anderlecht, , Belgium
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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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Barretos, , Brazil
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Florianópolis, , Brazil
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Ijuí, , Brazil
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Londrina, , 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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Taubaté, , 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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Sault Ste. Marie, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, 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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Changchun, , China
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Changde, , 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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Dalian, , 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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Hefei, , China
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Jinan, , China
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Kunming, , China
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Linhai, , China
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Linyi, , 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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Shanghai, , 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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Xi'an, , China
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Yangzhou, , China
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Yueyang, , 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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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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Heidelberg, , 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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Puducherry, , India
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Surat, , India
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Varanasi, , India
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Florence, , Italy
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Monza, , Italy
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Orbassano, , Italy
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Padua, , Italy
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Peschiera del Garda, , Italy
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Roma, , 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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Sakai, , Japan
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Sendai, , Japan
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Shinjuku-ku, , Japan
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Takaoka-shi, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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George Town, , Malaysia
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Johor Bahru, , Malaysia
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Kuala Lumpur, , 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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Zwolle, , 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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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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Cheongju-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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Seoul, , South Korea
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Suwon, , South Korea
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Suwon, , South Korea
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Barcelona, , Spain
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Las Palmas de Gran Canaria, , Spain
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Lleida, , 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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Antalya, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Yenimahalle, , 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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Preston, , 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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2024-514281-39-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D702BC00001
Identifier Type: -
Identifier Source: org_study_id