A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.
eVOLVE-Lung02
A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer (mNSCLC).
2 other identifiers
interventional
1,200
24 countries
251
Brief Summary
The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety of volrustomig in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 \< 50%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2023
Longer than P75 for phase_3
251 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
August 2, 2023
CompletedFirst Posted
Study publicly available on registry
August 9, 2023
CompletedStudy Start
First participant enrolled
October 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 23, 2029
March 17, 2026
March 1, 2026
4.5 years
August 2, 2023
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1)
PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression), in PD-L1-negative participants.
Up to approximately 6 years
Overall Survival (OS), in PD-L1-negative participants.
OS is defined as the time from randomization until the date of death due to any cause, in PD-L1-negative participants.
Up to approximately 6 years
Secondary Outcomes (10)
PFS (using BICR assessments according to RECIST 1.1)
Up to approximately 6 years
OS
Up to approximately 6 years
PFS (using Investigator assessments according to RECIST 1.1)
Up to approximately 6 years
Overall Response Rate (ORR)
Up to approximately 6 years
Duration of Response (DoR)
Up to approximately 6 years
- +5 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALVolrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
Arm 2
ACTIVE COMPARATORPembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically documented squamous or non-squamous NSCLC.
- Stage IV NSCLC (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology 2016), not amenable to curative surgery or radiation.
- Absence of sensitizing EGFR mutations and ALK and ROS1 rearrangements.
- Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted first-line therapies.
You may not qualify if:
- Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare subtypes are excluded.
- Spinal cord compression.
- Symptomatic brain metastases. Brain metastases may be treated or untreated, but participants must be asymptomatic and off steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and study enrollment.
- 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.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- As judged by the investigator, any condition that would interfere with evaluation of the study intervention or interpretation of participant safety or study results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (256)
Research Site
Prescott, Arizona, 86301, United States
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Hot Springs, Arkansas, 71913, United States
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Springdale, Arkansas, 72762, United States
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Long Beach, California, 90806, United States
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Lone Tree, Colorado, 80124, United States
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Fort Myers, Florida, 33901, United States
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Gainesville, Florida, 32610, United States
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Orlando, Florida, 32827, United States
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St. Petersburg, Florida, 33705, United States
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West Palm Beach, Florida, 33401, United States
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Fort Wayne, Indiana, 46804, United States
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Indianapolis, Indiana, 46202, United States
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Des Moines, Iowa, 50309, United States
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Lexington, Kentucky, 40503, United States
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Louisville, Kentucky, 40206, United States
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Annapolis, Maryland, 21401, United States
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Baltimore, Maryland, 21201, United States
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Silver Spring, Maryland, 20904, United States
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Towson, Maryland, 21204, United States
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Boston, Massachusetts, 02215, United States
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Detroit, Michigan, 48202, United States
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Grand Island, Nebraska, 68803, United States
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Lincoln, Nebraska, 68506, United States
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Omaha, Nebraska, 68130, United States
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Albuquerque, New Mexico, 87102, 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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Columbus, Ohio, 43210, United States
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Columbus, Ohio, 43219, United States
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Dayton, Ohio, 45428, United States
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Portland, Oregon, 97239, United States
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Horsham, Pennsylvania, 19044, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Memphis, Tennessee, 38104, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37212, United States
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Houston, Texas, 77090, United States
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Irving, Texas, 75063, United States
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Lancaster, Texas, 75216, United States
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Fairfax, Virginia, 22031, United States
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Tacoma, Washington, 98405, United States
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CABA, 1425, Argentina
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CABA, C1061, Argentina
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CABA, C1425, Argentina
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Córdoba, 5000, Argentina
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Córdoba, X5800HHW, Argentina
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La Plata, 1900, Argentina
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La Plata, B1900AVG, Argentina
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Rosario, 2000, Argentina
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Clayton, 3168, Australia
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Fitzroy, 3065, Australia
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Heidelberg, 3084, Australia
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South Brisbane, 4101, Australia
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Sydney, NSW 2145, Australia
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Linz, 4021, Austria
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Wels, 4600, Austria
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Aalst, 9300, Belgium
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Antwerp, 2020, Belgium
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Ghent, 9000, Belgium
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Barretos, 14784-400, Brazil
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Curitiba, 80730-150, Brazil
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Florianópolis, 88034-000, Brazil
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Fortaleza, 60336-045, Brazil
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Natal, 59075-740, Brazil
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Porto Alegre, 90619-900, Brazil
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Porto Alegre, 91350200, Brazil
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Rio de Janeiro, 22281-100, Brazil
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Santa Cruz do Sul, 96810-110, Brazil
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São Paulo, 01221-020, Brazil
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Calgary, Alberta, T2N 5G2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Winnipeg, Manitoba, R3E 0V9, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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Barrie, Ontario, L4M 6M2, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Lévis, Quebec, G6V 3Z1, Canada
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Trois-Rivières, Quebec, G8Z 3R0, Canada
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Chicoutimi, G7H 5H6, Canada
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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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Changchun, 130021, China
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Changsha, 410013, China
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Chengdu, 610000, China
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Chengdu, 611135, China
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Chongqing, 400030, China
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Fuzhou, 350011, China
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Guangzhou, 510080, China
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Hangzhou, 310020, China
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Hangzhou, 310022, China
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Hefei, 230601, China
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Lanzhou, 730000, China
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Linhai, 317000, China
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Linyi, 276001, China
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Nanchang, 330006, China
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Nanchang, 330008, China
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Nanjing, 210009, China
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Nanning, 530021, 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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Shenzhen, 518116, China
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Taiyuan, 030000, China
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Tianjin, 300060, China
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Wuhan, 430022, China
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Wuhan, 430030, China
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Wuhan, 430079, China
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Xi'an, 710000, China
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Yangzhou, 225001, China
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Zhengzhou, 450008, China
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Olomouc, 77900, Czechia
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Ostrava - Vitkovice, 703 84, Czechia
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Prague, 128 08, Czechia
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Angers, 49055, France
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Avignon, 84902, France
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Bayonne, 64100, France
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Bordeaux, 33076, France
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Caen, 14033, France
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Lille, 59037, France
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Limoges, 87042, France
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Marseille, 13273, France
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Paris, 75248, France
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Quimper, 29000, France
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Reims, 51092, France
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St-Malo, 35403, France
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Strasbourg, 67098, France
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Suresnes, 92150, France
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Toulon Naval, 83800, France
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Berlin-Zehlendorf, 14165, Germany
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Bonn, 53113, Germany
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Braunschweig, 38114, Germany
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Dresden, 01307, Germany
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Freiburg im Breisgau, 79106, Germany
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Gauting, 82131, Germany
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Georgsmarienhütte, 49124, Germany
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Gütersloh, 33332, Germany
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Halle, 06120, Germany
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Hamburg, 22087, Germany
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Heidelberg, 69126, Germany
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Immenhausen, 34376, Germany
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Koblenz, 56068, Germany
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Ludwigsburg, 71640, Germany
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Nuremberg, 90419, Germany
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Tübingen, 72076, Germany
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Velbert, 42551, 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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Szekszárd, 7100, Hungary
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Törökbálint, 2045, Hungary
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Bengaluru, 560085, India
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Hyderabad, 500032, India
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Kolkata, 700016, India
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Mysuru, 570017, India
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Nagpur, 440001, India
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Nashik, 422011, India
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Varanasi, 221005, India
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Bari, 70124, Italy
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Bergamo, 24125, Italy
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Milan, 20162, Italy
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Padua, 35128, Italy
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Parma, 43126, Italy
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Pavia, 27100, Italy
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Ravenna, 48100, Italy
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Roma, 00128, Italy
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Bunkyō City, 113-8677, Japan
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Fukuoka, 812-8582, Japan
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Kashiwa, 277-8577, Japan
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Kawasaki-shi, 216-8511, Japan
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Kōtoku, 135-8550, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 464-8681, Japan
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Okayama, 700-8558, Japan
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Osaka, 541-8567, Japan
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Sagamihara-shi, 252-0375, Japan
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Sakai, 590-0197, Japan
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Sapporo, 001-0013, Japan
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Sendai, 980-0873, Japan
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Ube-shi, 755-0241, Japan
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Yokohama, 241-8515, Japan
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Amsterdam, 1081 HV, Netherlands
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Groningen, 9728 NT, Netherlands
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Nieuwegein, 3435 CM, Netherlands
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Tilburg, 5042AD, Netherlands
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Lublin, 20-090, Poland
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Poznan, 60-569, Poland
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Przemyśl, 37-700, Poland
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Radom, 26-600, Poland
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Warsaw, 01-138, Poland
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Warsaw, 02-781, Poland
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Banská Bystrica, 97517, Slovakia
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Bratislava, 82606, Slovakia
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Bratislava, 833 01, Slovakia
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Košice, 041 91, Slovakia
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Trnava, 917 75, Slovakia
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eManzimtoti, 4126, South Africa
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George, 6529, South Africa
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Johannesburg, 2193, South Africa
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Johannesburg, 2196, South Africa
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Pietermaritzburg, 3245, South Africa
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Pretoria, 0002, South Africa
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Rondebosch, 7700, South Africa
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Soweto, 2013, South Africa
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Cheongju-si, 28644, South Korea
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Daegu, 42601, South Korea
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Incheon, 21565, South Korea
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Jinju, 52727, South Korea
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Seoul, 03080, South Korea
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Seoul, 06351, South Korea
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Seoul, 07061, South Korea
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Suwon, 16247, South Korea
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Suwon, 16499, South Korea
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Alicante, 03010, Spain
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Barcelona, 08003, Spain
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Barcelona, 08025, Spain
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Bilbao (Vizcaya), 48013, Spain
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Madrid, 28040, Spain
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Málaga, 29011, Spain
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Palma, 07198, Spain
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Kaohsiung City, 80756, Taiwan
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Kaohsiung City, 833, Taiwan
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New Taipei City, 220, Taiwan
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Tainan, 70403, Taiwan
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Tainan, 73657, Taiwan
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Taipei, 100, Taiwan
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Taipei, 112, Taiwan
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Taipei, 11490, Taiwan
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Taoyuan District, 33305, Taiwan
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Yunlin, 640, Taiwan
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Bangkok, 10700, Thailand
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Dusit, 10300, Thailand
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Lampang, 52000, Thailand
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Muang, 50200, 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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Çankaya, 06680, Turkey (Türkiye)
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Diyarbakır, 21280, Turkey (Türkiye)
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Fatih-Istanbul, 34098, Turkey (Türkiye)
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Istanbul, 34722, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Pamukkale, 20070, Turkey (Türkiye)
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Birmingham, B9 5SS, United Kingdom
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Blackpool, FY3 8NR, United Kingdom
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Bury St Edmunds, IP332QZ, United Kingdom
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Colchester, CO4 5JL, United Kingdom
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London, EC1A 7BE, United Kingdom
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London, SW10 9NH, United Kingdom
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London, SW170QT, United Kingdom
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Truro, TR1 3LJ, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- None (Open Label)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2023
First Posted
August 9, 2023
Study Start
October 24, 2023
Primary Completion (Estimated)
April 24, 2028
Study Completion (Estimated)
March 23, 2029
Last Updated
March 17, 2026
Record last verified: 2026-03
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 rerefer 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 de-identified individual patient-level data in an approved sponsored tool. SignedData Sharing Agreement (non-negotiable contract for data accessors) must be inplace before accessing requested information. Additionally, all users will need toaccept the terms and conditions of the SAS MSE to gain access. For additionaldetails, please review the Disclosure Statements athttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.