A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)
2 other identifiers
interventional
880
25 countries
297
Brief Summary
The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started Nov 2024
297 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2024
CompletedFirst Posted
Study publicly available on registry
November 18, 2024
CompletedStudy Start
First participant enrolled
November 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 8, 2029
May 1, 2026
April 1, 2026
4.2 years
October 4, 2024
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall survival (OS)
OS is defined as the time from randomization until the date of death due to any cause.
Up to approximately 5 years
Progression-free survival (PFS)
PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression).
Up to approximately 5 years
Secondary Outcomes (10)
Landmark overall survival (OS) rates
Up to approximately 5 years
Landmark progression-free survival (PFS) rates
Up to approximately 5 years
Time to second progression or death (PFS2)
Up to approximately 5 years
Overall response rate (ORR)
Up to approximately 5 years
Duration of response (DoR)
Up to approximately 5 years
- +5 more secondary outcomes
Study Arms (2)
Arm A
EXPERIMENTALRilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig
Arm B
ACTIVE COMPARATORPembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab
Interventions
Administered intravenously (IV) on Day 1 of each 21-day cycle
Administered intravenously (IV) on Day 1 of each 21-day cycle
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles
Eligibility Criteria
You may qualify if:
- Histologically or cytologically documented squamous NSCLC.
- 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.
You may not qualify if:
- Presence of small cell and neuroendocrine histology components.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (301)
Research Site
Tucson, Arizona, 85724, United States
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Springdale, Arkansas, 72762, United States
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Anaheim, California, 92801, United States
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Beverly Hills, California, 90211, United States
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Loma Linda, California, 92354, United States
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Los Alamitos, California, 90720, United States
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Redlands, California, 92373, United States
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San Francisco, California, 94121, United States
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Walnut Creek, California, 94598, United States
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West Haven, Connecticut, 06516, United States
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Newark, Delaware, 19713, United States
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Bay Pines, Florida, 33744, United States
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Fort Lauderdale, Florida, 33308, United States
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Gainesville, Florida, 32608, United States
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Gainesville, Florida, 32610, United States
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Jacksonville, Florida, 32224, United States
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Athens, Georgia, 30607, United States
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Atlanta, Georgia, 30341, United States
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Boise, Idaho, 83712, United States
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Chicago, Illinois, 60637, United States
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Decatur, Illinois, 62526, United States
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Hinsdale, Illinois, 60521, United States
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Quincy, Illinois, 62301, United States
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Rockford, Illinois, 61114, United States
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Waterloo, Iowa, 50702, United States
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Lexington, Kentucky, 40509, United States
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Lexington, Kentucky, 40536, United States
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Louisville, Kentucky, 40202, United States
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Louisville, Kentucky, 40207, United States
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Alexandria, Louisiana, 71301, United States
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Baton Rouge, Louisiana, 70808, United States
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Covington, Louisiana, 70433, United States
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Shreveport, Louisiana, 71103, United States
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Shreveport, Louisiana, 71105, United States
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South Portland, Maine, 04106, United States
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Baltimore, Maryland, 21202, United States
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Bethesda, Maryland, 20817, United States
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Detroit, Michigan, 48202, United States
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Grand Rapids, Michigan, 49503, United States
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Duluth, Minnesota, 55802, United States
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Rochester, Minnesota, 55905, United States
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Bridgeton, Missouri, 63044, United States
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Columbia, Missouri, 65212, United States
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Kansas City, Missouri, 64108, United States
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Lincoln, Nebraska, 68506, United States
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Camden, New Jersey, 08103, United States
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Buffalo, New York, 14221, United States
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East Syracuse, New York, 13057, United States
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Westbury, New York, 11590, United States
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Grand Forks, North Dakota, 58201, United States
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Canton, Ohio, 44718, United States
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Cincinnati, Ohio, 45267, United States
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Bend, Oregon, 97701, United States
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Medford, Oregon, 97504, United States
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Salem, Oregon, 97301, United States
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Hershey, Pennsylvania, 17033, United States
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York, Pennsylvania, 17403, United States
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Sioux Falls, South Dakota, 57105, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77090, United States
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Kingwood, Texas, 77339, United States
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Lubbock, Texas, 79410, United States
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Round Rock, Texas, 78665, United States
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Fairfax, Virginia, 22031, United States
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Fredericksburg, Virginia, 22408, United States
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Olympia, Washington, 98506, United States
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Seattle, Washington, 98101, United States
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Silverdale, Washington, 98383, United States
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Spokane, Washington, 99208, United States
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Tacoma, Washington, 98405, United States
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Wenatchee, Washington, 98801, United States
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Buenos Aires, C1431FWO, Argentina
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CABA, 1425, Argentina
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La Plata, 1900, Argentina
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Pilar, B1629ODT, Argentina
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Rosario, S2000DEJ, Argentina
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Darlinghurst, 2010, Australia
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Hyde Park, 4812, Australia
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Southport, 4215, Australia
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Wollongong, 2500, Australia
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Innsbruck, 6020, Austria
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Krems, 3500, Austria
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Rankweil, 6830, Austria
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Vienna, 1160, Austria
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Vienna, 1210, Austria
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Anderlecht, 1070, Belgium
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Brussels, 1160, Belgium
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Charleroi, 6060, Belgium
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Kortrijk, 8500, Belgium
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Ottignies, 1340, Belgium
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Sint-Niklaas, 9100, Belgium
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Barretos, 14784-400, Brazil
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Florianópolis, 88034-000, Brazil
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Ijuí, 98700-000, Brazil
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Londrina, 86015-520, Brazil
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Porto Alegre, 91350-200, Brazil
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Salvador, 40050 410, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 05652-900, Brazil
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Taubaté, 12030-200, Brazil
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Saint John, New Brunswick, E2L 4L2, Canada
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Sydney, Nova Scotia, B1P 1P3, Canada
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Hamilton, Ontario, L8V 1C3, Canada
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Sault Ste. Marie, Ontario, P6A 0A8, Canada
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Montreal, Quebec, H2X 0A9, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Beijing, 100021, China
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Beijing, 100029, China
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Beijing, 100142, China
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Beijing, 101149, China
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Beijing, CN-100730, China
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Changchun, 130012, China
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Changde, 415000, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chengdu, 610072, China
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Chongqing, 400030, China
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Dalian, 116001, China
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Guangzhou, 510062, China
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Guangzhou, 510100, China
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Hangzhou, 310003, China
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Hangzhou, 310016, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Hefei, 230001, China
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Hefei, 230601, China
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Jinan, 250117, China
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Kunming, 650118, China
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Linhai, 317000, China
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Linyi, 276001, China
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Nanchang, 330008, China
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Ningbo, 315010, China
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Shanghai, 200030, China
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Shanghai, 200032, China
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Shanghai, 200433, China
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Shenyang, 110004, China
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Shenzhen, 518020, China
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Taiyuan, 030000, China
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Tianjin, 300050, China
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Wenzhou, CN-325000, China
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Wuhan, 430030, China
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Xi'an, 710061, China
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Yangzhou, 225001, China
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Yueyang, 414000, China
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Zhengzhou, 450008, China
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Zhengzhou, 450052, China
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Avignon, 84902, France
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La Rochelle, 17019, France
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Lyon, 69008, France
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Nîmes, 30029, France
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Rennes, 35033, France
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Strasbourg, 67091, France
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Suresnes, 92150, France
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Toulon, 83800, France
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Bad Berka, 99437, Germany
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Berlin, 13125, Germany
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Berlin, 13585, Germany
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Bielefeld, 33611, Germany
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Cologne, 51109, Germany
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Esslingen am Neckar, 73730, Germany
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Frankfurt, 60488, Germany
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Gauting, 82131, Germany
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Giessen, 35392, Germany
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Großhansdorf, 22927, Germany
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Hamburg, 20251, Germany
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Hanover, 30459, Germany
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Hanover, 30625, Germany
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Heidelberg, 69126, Germany
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Hemer, 58675, Germany
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Homburg, 66424, Germany
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Kassel, 34125, Germany
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Kiel, 24105, Germany
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Krefeld, 47805, Germany
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Minden, 32429, Germany
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Moers, 47441, Germany
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München, 81925, Germany
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Regensburg, 93053, Germany
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Würzburg, 97067, Germany
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Budapest, 1083, Hungary
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Budapest, 1121, Hungary
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Budapest, 1122, Hungary
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Debrecen, 4032, Hungary
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Gyöngyös, 3200, Hungary
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Gyöngyös - Mátraháza, 3200, Hungary
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Győr, 9024, Hungary
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Pécs, 7624, Hungary
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Székesfehérvár, 8000, Hungary
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Törökbálint, 2045, Hungary
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Calicut, 673601, India
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Delhi, 110029, India
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Kolkata, 700054, India
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Madurai, 625107, India
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Mumbai, 400012, India
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Nashik, 422002, India
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New Delhi, 110075, India
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Puducherry, 605006, India
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Surat, 395017, India
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Varanasi, 221005, India
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Florence, 50134, Italy
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Monza, 20900, Italy
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Orbassano, 10043, Italy
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Padova, 35128, Italy
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Peschiera del Garda, 37019, Italy
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Roma, 00168, Italy
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Amagasaki-shi, 660-8550, Japan
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Bunkyō City, 113-8603, Japan
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Chūōku, 104-0045, Japan
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Fukuoka, 812-8582, Japan
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Fukuoka, 814-0180, Japan
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Hiroshima, 734-8551, Japan
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Kawagoe-shi, 350-8550, Japan
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Kawasaki-shi, 216-8511, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kitakyushu-shi, 807-8555, Japan
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Kobe, 650-0017, Japan
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Kōtoku, 135-8550, Japan
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Kumamoto, 860-8556, Japan
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Kumamoto, 861-4193, Japan
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Kyoto, 612-8555, Japan
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Matsusaka-shi, 515-8544, Japan
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Osaka, 541-8567, Japan
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Ota-shi, 373-8550, Japan
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Saitama-shi, 338-0001, Japan
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Sakai, 590-0197, Japan
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Sendai, 981-0914, Japan
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Shinjuku-ku, 160-0023, Japan
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Takaoka-shi, 933-8555, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 241-8515, Japan
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George Town, 10450, Malaysia
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Johor Bahru, 81100, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Alkmaar, 1815 JD, Netherlands
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Ede, 6716 RP, Netherlands
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Groningen, 9713 GZ, Netherlands
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Leidschendam, 2262 BA, Netherlands
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Veldhoven, 5504 DB, Netherlands
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Zwolle, 8025 AB, Netherlands
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Lima, 15036, Peru
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Lima, 15102, Peru
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Lima, 34, Peru
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Lima, L27, Peru
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Lima, LIMA 29, Peru
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Lima, Lima39, Peru
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Bialystok, 15-027, Poland
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Biała Podlaska, 21-500, Poland
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Bydgoszcz, 85-796, Poland
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Bystra, 43-360, Poland
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Lodz, 93-338, Poland
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Poznan, 60-569, Poland
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Warsaw, 04-141, Poland
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San Juan, 00909, Puerto Rico
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San Juan, 00918, Puerto Rico
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Cheongju-si, 28644, South Korea
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Incheon, 21565, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Suwon, 16247, South Korea
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Suwon, 16499, South Korea
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Barcelona, 8035, Spain
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Las Palmas de Gran Canaria, 35016, Spain
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Lleida, 25198, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Majadahonda, 28222, Spain
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Seville, 41013, Spain
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Kaohsiung City, 80756, Taiwan
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Kaohsiung City, 824, Taiwan
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New Taipei City, 220, Taiwan
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New Taipei City, 23561, Taiwan
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Taichung, 402, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 73657, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Dusit, 10300, Thailand
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Nakhon Ratchasima, 30000, Thailand
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Songkhla, 90110, Thailand
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Ankara, 6500, Turkey (Türkiye)
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Antalya, 07059, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Yenimahalle, 06170, Turkey (Türkiye)
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Aberdeen, AB25 2ZN, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Exeter, EX2 5DW, United Kingdom
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Greater London, SW3 6JJ, United Kingdom
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London, EC1A 7BE, United Kingdom
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London, SE1 9RT, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Newcastle upon Tyne, NE7 7AF, United Kingdom
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Preston, PR2 9HT, United Kingdom
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Can Tho, 900000, Vietnam
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Vinh, 460000, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind masking
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2024
First Posted
November 18, 2024
Study Start
November 18, 2024
Primary Completion (Estimated)
February 5, 2029
Study Completion (Estimated)
October 8, 2029
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the European Federation of Pharmaceutical Industries and Associations (EFPIA)/Pharmaceutical Research and Manufacturers of America (PhRMA) Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca (AZ) group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for Important Protocol Deviation (IPD), but this does not mean all requests will be approved.