A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer
ARTEMIDELung04
A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients With PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04)
2 other identifiers
interventional
830
26 countries
290
Brief Summary
The purpose of ARTEMIDE-Lung04 is to assess the efficacy and safety of rilvegostomig compared with pembrolizumab monotherapy as 1L treatment in participants with mNSCLC and whose tumors express 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
Started Apr 2025
Longer than P75 for phase_3
290 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
March 7, 2025
CompletedFirst Posted
Study publicly available on registry
March 10, 2025
CompletedStudy Start
First participant enrolled
April 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 2, 2030
April 24, 2026
April 1, 2026
4.8 years
March 7, 2025
April 23, 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 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
Objective Response Rate (ORR)
Up to approximately 5 years
Duration of Response (DoR)
Up to approximately 5 years
Time to second progression or death (PFS2)
Up to approximately 5 years
- +5 more secondary outcomes
Study Arms (2)
Arm A
EXPERIMENTALDrug: rilvegostomig
Arm B
ACTIVE COMPARATORDrug: Pembrolizumab
Interventions
Administered intravenously (IV) on Day 1 of each 21-day cycle
Administered intravenously (IV) on Day 1 of each 21-day cycle
Eligibility Criteria
You may qualify if:
- Histologically or cytologically documented NSCLC (non small lung cancer), including all histological subtypes.
- 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
You may not qualify if:
- As judged by the investigator, any severe or uncontrolled systemic diseases, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (294)
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La Mesa, California, 91942, United States
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Los Alamitos, California, 90720, 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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Clearwater, Florida, 33756, United States
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St. Petersburg, Florida, 33705, United States
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Marietta, Georgia, 30060, United States
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Chicago, Illinois, 60612, United States
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Decatur, Illinois, 62526, United States
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Des Moines, Iowa, 50309, United States
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Waterloo, Iowa, 50702, United States
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Leawood, Kansas, 66209, United States
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Lexington, Kentucky, 40536, United States
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Owensboro, Kentucky, 42303, United States
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Bethesda, Maryland, 20817, United States
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Frederick, Maryland, 21702, United States
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Silver Spring, Maryland, 20910, United States
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Towson, Maryland, 21204, United States
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Bridgeton, Missouri, 63044, United States
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Lincoln, Nebraska, 68506, United States
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Paramus, New Jersey, 07652, United States
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Buffalo, New York, 14215, United States
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East Syracuse, New York, 13057, United States
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Fresh Meadows, New York, 11366, United States
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Rochester, New York, 14642, United States
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Westbury, New York, 11590, United States
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Canton, Ohio, 44718, United States
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Fountain Hill, Pennsylvania, 18015, United States
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Kittanning, Pennsylvania, 16201, United States
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Philadelphia, Pennsylvania, 19104, United States
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Round Rock, Texas, 78665, United States
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Aberdeen, Washington, 98520, United States
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Renton, Washington, 98055, United States
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Charleston, West Virginia, 25304, United States
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Morgantown, West Virginia, 26506, United States
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CABA, 1425, Argentina
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Córdoba, 5000, Argentina
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Pilar, B1629AHJ, Argentina
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Rosario, 2000, Argentina
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Rosario, S2000CVB, Argentina
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Viedma, R8500ACE, Argentina
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Hobart, 7000, Australia
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Woolloongabba, 4102, Australia
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Edegem, 2650, Belgium
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Jette, 1090, Belgium
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Libramont-Chevigny, 6800, Belgium
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Liège, 4000, Belgium
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Mechelen, 2800, Belgium
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Roeselaere, 8800, Belgium
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Blumenau, 89010-340, Brazil
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Fortaleza, 60336-550, Brazil
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Ijuí, 98700-000, Brazil
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Itajaí, 88301-220, Brazil
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Londrina, 86015-520, Brazil
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Passo Fundo, 99010-260, Brazil
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Porto Alegre, 90035-903, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Velho, 76834-899, Brazil
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Salvador, 41253-190, Brazil
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Salvador, 41950-640, Brazil
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Santo André, 09060-650, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 04501-000, Brazil
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Teresina, 64049-200, Brazil
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Burgas, 8000, Bulgaria
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Panagyurishte, 4500, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1618, Bulgaria
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Sofia, 1756, Bulgaria
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Varna, 9010, Bulgaria
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Edmonton, Alberta, T6G 1Z2, Canada
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Kelowna, British Columbia, V1Y 5L3, Canada
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Cambridge, Ontario, N1R 3G2, Canada
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Newmarket, Ontario, L3Y 2P9, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Québec, Quebec, G1V 4G5, Canada
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Saint-Jérôme, Quebec, J7Z 5T3, Canada
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Conception, 4070196, Chile
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Santiago, 7500653, Chile
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Santiago, 7500713, Chile
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Santiago, 8420383, Chile
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Baoding, 071000, China
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Beijing, 100021, China
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Beijing, 100142, China
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Beijing, 101149, China
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Bengbu, 233004, China
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Changchun, 130000, China
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Changchun, 130033, China
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Changsha, 410008, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chongqing, 400030, China
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Chongqing, 400042, China
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Fuzhou, 350001, China
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Fuzhou, 350014, China
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Guangzhou, 510080, China
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Haerbin, 150081, China
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Hangzhou, 310022, China
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Hefei, 133500, China
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Hefei, 230022, China
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Jiamusi, 154007, China
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Jinan, 250117, China
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Lanzhou, 730050, China
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Linyi, 276001, China
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Liuchow, 545007, China
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Nanchang, 330006, China
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Nanchang, 330029, China
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Nanjing, 210006, China
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Nanjing, 210008, China
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Nanning, 530021, China
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Ningbo, 315010, China
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Qingdao, 266071, China
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Shanghai, 200092, China
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Shenyang, 110042, China
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Suzhou, 215004, China
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Taiyuan, 030000, China
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Wuhan, 430030, China
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Wuhan, 430060, China
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Xuzhou, 221002, China
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Yantai, 264000, China
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Zhengzhou, 450008, China
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Cali, 760032, Colombia
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Floridablanca, 680001, Colombia
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Medellín, 050034, Colombia
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Valledupar, 200001, Colombia
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San José, 1000, Costa Rica
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San José, 10108, Costa Rica
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San José Capital, 1000, Costa Rica
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Santa Ana, 10903, Costa Rica
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Angers, 49100, France
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Avignon, 84000, France
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Boulogne-Billancourt, 92100, France
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Caen, 14000, France
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Chambéry, 73011, France
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Dijon, 21000, France
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La Tronche, 38700, France
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Limoges, 87042, France
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Nantes, 44093, France
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Paris, 75020, France
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Pau, 64046, France
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St-Malo, 35403, France
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Toulouse, 31300, France
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Tbilisi, 0112, Georgia
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Tbilisi, 0159, Georgia
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Tbilisi, 160, Georgia
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Tbilisi, 177, Georgia
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Amberg, 92224, Germany
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Augsburg, by, 86156, Germany
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Bad Saarow, 15526, Germany
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Berlin, 12351, Germany
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Berlin, 13359, Germany
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Bonn, 53127, Germany
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Braunschweig, 38114, Germany
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Essen, 45147, Germany
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Flensburg, 24939, Germany
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Frankfurt am Main, 60431, Germany
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Hamburg, 21075, Germany
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Heidelberg, 69126, Germany
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Heilbronn, 74078, Germany
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Immenhausen, 34376, Germany
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Koblenz, 56073, Germany
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Leipzig, 04103, Germany
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München, 80336, Germany
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Offenbach, 63069, Germany
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Oldenburg, 26121, Germany
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Remscheid, 42859, Germany
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Rotenburg (Wümme), 27356, Germany
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Schweinfurt, 97421, Germany
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Trier, 54292, Germany
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Velbert, 42551, Germany
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Wuppertal, 42283, Germany
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Würselen, 52146, Germany
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Würzburg, 97080, Germany
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Athens, 115 27, Greece
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Athens, 11527, Greece
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Athens, 12462, Greece
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Piraeus, 185 37, Greece
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Piraeus, 185 47, Greece
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Thessaloniki, 55236, Greece
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Thessaloniki, 55236, Greece
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Thessaloniki, 56429, Greece
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Thessaloniki, 57001, Greece
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Dublin, D07 R2WY, Ireland
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Dublin, D08 NHY1, Ireland
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Dublin, D09 V2N0, Ireland
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Dublin, D24 NR0A, Ireland
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Dublin, DO4YN63, Ireland
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Galway, H91 YR71, Ireland
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Afula, 1834111, Israel
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Beersheba, 8410101, Israel
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Hadera, 38100, Israel
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Haifa, 34362, Israel
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Haifa, 91096, Israel
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Jerusalem, 91031, Israel
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Jerusalem, 91120, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 64239, Israel
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Tel Aviv, 69710, Israel
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Candiolo, 10060, Italy
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Lecco, 23900, Italy
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Lucca, 55100, Italy
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Meldola, 47014, Italy
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Milan, 20133, Italy
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Naples, 80131, Italy
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Peschiera del Garda, 37019, Italy
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Pisa, 56126, Italy
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Roma, 00144, Italy
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Torrette Di Ancona, 60126, Italy
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Udine, 33100, Italy
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Verona, 37126, Italy
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Akashi, 673-8558, Japan
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Bunkyō City, 113-8603, Japan
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Bunkyō City, 113-8677, Japan
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Fukuoka, 811-1395, Japan
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Fukuoka, 812-8582, Japan
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Hamamatsu, 431-3192, Japan
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Iwakuni-shi, 740-8510, Japan
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Izumi-shi, 594-0073, Japan
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Kashihara-shi, 634-8522, Japan
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Kobe, 650-0046, Japan
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Kōtoku, 135-8550, Japan
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Kurume-shi, 830-0011, Japan
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Kyoto, 602-8566, Japan
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Matsuyama, 791-0280, Japan
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Nankoku-shi, 783-8505, Japan
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Niigata, 951-8566, Japan
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Osaka, 534-0021, Japan
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Sakaishi, 591-8555, Japan
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Sayama, 589-8511, Japan
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Sendai, 980-0873, Japan
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Shinagawa-ku, 142-8666, Japan
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Takarazuka-shi, 665-0827, Japan
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Toon-Shi, 791-0295, Japan
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Toyoake-shi, 470-1192, Japan
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Toyonaka-shi, 560-8552, Japan
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George Town, 10350, Malaysia
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Kota Bharu, 15586, Malaysia
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Kuala Lumpur, 50586, Malaysia
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Kuala Selangor, 62250, Malaysia
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Perai, 13700, Malaysia
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Alcabideche, 2755-009, Portugal
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Braga, 4710-243, Portugal
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Coimbra, 3000-075, Portugal
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Lisbon, 1400-038, Portugal
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Lisbon, 1500-650, Portugal
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Lisbon, 1769-001, Portugal
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Loures, 2674-514, Portugal
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Matosinhos Municipality, 4454-509, Portugal
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Porto, 4100-180, Portugal
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Porto, 4200-072, Portugal
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Porto, 4200-319, Portugal
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Bucharest, 010626, Romania
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Bucharest, 013812, Romania
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Bucharest, 022328, Romania
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Bucharest, 30167, Romania
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Craiova, 200385, Romania
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Craiova, 200542, Romania
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Iași, 700106, Romania
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Otopeni, 075100, Romania
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Piteşti, 110283, Romania
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Sibiu, 550253, Romania
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Timișoara, 300239, Romania
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Jinju, 52727, South Korea
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Seoul, 135-710, South Korea
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Seoul, 5505, South Korea
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Badajoz, 06080, Spain
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Badalona, 8916, Spain
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Barcelona, 08028, Spain
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Castellon, 12002, Spain
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Granada, 18016, Spain
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Jaén, 23007, Spain
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Lugo, 27003, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Madrid, 28050, Spain
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Málaga, 29010, Spain
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Oviedo, 33006, Spain
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Palma de Mallorca, 07198, Spain
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Valencia, 46015, Spain
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Vigo (Pontevedra), 36312, Spain
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Zaragoza, 50009, Spain
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Lausanne, 1011, Switzerland
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Ankara, 06010, Turkey (Türkiye)
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Bakırköy, 34147, Turkey (Türkiye)
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Çankaya, 06680, Turkey (Türkiye)
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İzmit, 41380, Turkey (Türkiye)
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Küçükçekmece, 34295, Turkey (Türkiye)
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Yüreğir, 01240, Turkey (Türkiye)
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Blackpool, FY3 8NR, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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Guildford, GU2 7XX, United Kingdom
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Hull, HU16 5JQ, United Kingdom
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Oxford, OX4 6LB, United Kingdom
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Stevenage, SG1 4AB, United Kingdom
MeSH Terms
Conditions
Interventions
Condition 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
March 7, 2025
First Posted
March 10, 2025
Study Start
April 10, 2025
Primary Completion (Estimated)
January 17, 2030
Study Completion (Estimated)
December 2, 2030
Last Updated
April 24, 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 EFPIA Pharma 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 participant-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. 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 IPD, but this does not mean all requests will be shared.