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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06868277




Registration number
NCT06868277
Ethics application status
Date submitted
7/03/2025
Date registered
10/03/2025

Titles & IDs
Public title
A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer
Scientific title
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)
Secondary ID [1] 0 0
2024-517780-24-00
Secondary ID [2] 0 0
D702GC00001
Universal Trial Number (UTN)
Trial acronym
ARTEMIDELung04
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Rilvegostomig
Treatment: Other - Pembrolizumab

Experimental: Arm A - Drug: rilvegostomig

Active comparator: Arm B - Drug: Pembrolizumab


Treatment: Other: Rilvegostomig
Administered intravenously (IV) on Day 1 of each 21-day cycle

Treatment: Other: Pembrolizumab
Administered intravenously (IV) on Day 1 of each 21-day cycle
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 5 years
Primary outcome [2] 0 0
Progression-Free Survival (PFS)
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Landmark Overall Survival (OS) rates
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
Landmark Progression-Free Survival (PFS) rates
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [4] 0 0
Duration of Response (DoR)
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
Time to second progression or death (PFS2)
Timepoint [5] 0 0
Up to approximately 5 years
Secondary outcome [6] 0 0
Pharmakokinetics (PK) of rilvegostomig
Timepoint [6] 0 0
Up to approximately 5 years
Secondary outcome [7] 0 0
Immunogenicity of rilvegostomig
Timepoint [7] 0 0
Up to approximately 5 years
Secondary outcome [8] 0 0
Patient-reported physical functioning
Timepoint [8] 0 0
Up to approximately 5 years
Secondary outcome [9] 0 0
Patient-reported global health status (GHS)/quality of life (QoL)
Timepoint [9] 0 0
Up to approximately 5 years
Secondary outcome [10] 0 0
Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)
Timepoint [10] 0 0
Up to approximately 5 years

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/04/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/12/2030
Actual
Sample size
Target
830
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Hobart
Recruitment postcode(s) [1] 0 0
7000 - Hobart
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
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United States of America
State/province [2] 0 0
Illinois
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United States of America
State/province [3] 0 0
Iowa
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United States of America
State/province [4] 0 0
Kansas
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United States of America
State/province [5] 0 0
Maryland
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Pennsylvania
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Argentina
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Cordoba
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Belgium
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Edegem
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Belgium
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Liège
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Belgium
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Mechelen
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Belgium
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Roeselaere
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Brazil
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Blumenau
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Brazil
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Fortaleza
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Brazil
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Ijui
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Brazil
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Itajai
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Brazil
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Passo Fundo
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Brazil
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Porto Alegre
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Brazil
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Porto Velho
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Bulgaria
State/province [21] 0 0
Burgas
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Panagyurishte
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Sofia
Country [24] 0 0
China
State/province [24] 0 0
Baoding
Country [25] 0 0
China
State/province [25] 0 0
Beijing
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China
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Changchun
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China
State/province [27] 0 0
Changsha
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China
State/province [28] 0 0
Chongqing
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China
State/province [29] 0 0
Fuzhou
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China
State/province [30] 0 0
Guangzhou
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China
State/province [31] 0 0
Jiamusi
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China
State/province [32] 0 0
Jinan
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China
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Lanzhou
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China
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Linyi
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China
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Nanchang
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China
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Nanjing
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China
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Ningbo
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China
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Shanghai
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China
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Shenyang
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China
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Suzhou
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China
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Wuhan
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China
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Xuzhou
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China
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Yantai
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Colombia
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Valledupar
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France
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Avignon
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France
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Caen
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France
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Dijon
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France
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La Tronche
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France
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Paris
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France
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Pau Cedex
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France
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Toulouse
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Georgia
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Tbilisi
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Germany
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Amberg
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Germany
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Bad Saarow
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Essen
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Germany
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Frankfurt am Main
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Germany
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Heilbronn
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Germany
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Immenhausen
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Germany
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Koblenz
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Germany
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Leipzig
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Germany
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München
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Germany
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Oldenburg
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Germany
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Rotenburg
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Germany
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Schweinfurt
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Germany
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Velbert
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Germany
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Würselen
Country [69] 0 0
Germany
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Würzburg
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Greece
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Athens
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Greece
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Peiraias
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Greece
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Thessaloniki
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Israel
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Afula
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Israel
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Beer-Sheva
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Israel
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Hadera
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Italy
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Candiolo
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Italy
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Lucca
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Italy
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Pisa
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Italy
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Udine
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Verona
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Akashi
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Fukuoka-shi
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Fukuoka-Shi
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Hamamatsu-shi
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Iwakuni-shi
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Izumi-shi
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Kobe
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Koto-ku
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Kurume-shi
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Kyoto-shi
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Matsuyama-shi
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Nankoku-shi
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Niigata-shi
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Osaka-shi
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Osakasayama
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Sakai-shi
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Sendai-shi
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Shinagawa-ku
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Japan
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Toyoake-shi
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Japan
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Toyonaka-shi
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Malaysia
State/province [104] 0 0
Kuala Lumpur
Country [105] 0 0
Malaysia
State/province [105] 0 0
Perai
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Malaysia
State/province [106] 0 0
Selangor
Country [107] 0 0
Portugal
State/province [107] 0 0
Alcabideche
Country [108] 0 0
Portugal
State/province [108] 0 0
Lisboa
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Portugal
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Lisbon
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Portugal
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Porto
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Romania
State/province [111] 0 0
Bucuresti
Country [112] 0 0
Romania
State/province [112] 0 0
Craiova
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Romania
State/province [113] 0 0
Iasi
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Romania
State/province [114] 0 0
Pitesti
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Spain
State/province [115] 0 0
Badalona
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Spain
State/province [116] 0 0
Castellón
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Spain
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Granada
Country [118] 0 0
Spain
State/province [118] 0 0
Madrid
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Spain
State/province [119] 0 0
Málaga
Country [120] 0 0
Spain
State/province [120] 0 0
Oviedo
Country [121] 0 0
Turkey
State/province [121] 0 0
Izmit
Country [122] 0 0
Turkey
State/province [122] 0 0
Yüregir
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Blackpool

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06868277