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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
Date last updated
15/06/2025
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
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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)
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Secondary ID [1]
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2024-517780-24-00
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Secondary ID [2]
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D702GC00001
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Universal Trial Number (UTN)
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Trial acronym
ARTEMIDELung04
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small Cell Lung
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Condition category
Condition code
Cancer
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0
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Lung - Mesothelioma
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Cancer
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0
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0
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Lung - Non small cell
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Cancer
0
0
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from randomization until the date of death due to any cause.
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Timepoint [1]
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Up to approximately 5 years
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Primary outcome [2]
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Progression-Free Survival (PFS)
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Assessment method [2]
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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).
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Timepoint [2]
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Up to approximately 5 years
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Secondary outcome [1]
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Landmark Overall Survival (OS) rates
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Assessment method [1]
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OS is defined as the time from randomization until the date of death due to any cause.
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Timepoint [1]
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Up to approximately 5 years
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Secondary outcome [2]
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Landmark Progression-Free Survival (PFS) rates
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Assessment method [2]
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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).
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Timepoint [2]
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Up to approximately 5 years
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Secondary outcome [3]
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Objective Response Rate (ORR)
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Assessment method [3]
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ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, using RECIST 1.1.
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Timepoint [3]
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Up to approximately 5 years
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Secondary outcome [4]
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Duration of Response (DoR)
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Assessment method [4]
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DoR is defined as the time from the date of first documented response until the date of documented progression using RECIST 1.1 or death due to any cause (in the absence of progression).
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Timepoint [4]
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Up to approximately 5 years
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Secondary outcome [5]
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Time to second progression or death (PFS2)
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Assessment method [5]
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PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial investigator-assessed progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first.
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Timepoint [5]
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Up to approximately 5 years
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Secondary outcome [6]
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Pharmakokinetics (PK) of rilvegostomig
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Assessment method [6]
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Concentration of rilvegostomig in serum
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Timepoint [6]
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Up to approximately 5 years
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Secondary outcome [7]
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Immunogenicity of rilvegostomig
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Assessment method [7]
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Presence of antidrug antibodies (ADAs), titer, and neutralizing antibodies for rilvegostomig.
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Timepoint [7]
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Up to approximately 5 years
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Secondary outcome [8]
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Patient-reported physical functioning
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Assessment method [8]
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Proportion of participants with maintained or improved physical functioning as measured by Patient-Reported Outcomes Measurement Information System Physical Function - Short Form 8c - 7 day (PROMIS PF-SF 8c - 7 day) at each time point.
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Timepoint [8]
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Up to approximately 5 years
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Secondary outcome [9]
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Patient-reported global health status (GHS)/quality of life (QoL)
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Assessment method [9]
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Time to deterioration (TTD) of GHS/QoL as measured by the European Organization for Research and Treatment of Cancer Item Library 172 (EORTC IL172). TTD is defined as time from randomization to the date of first deterioration.
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Timepoint [9]
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Up to approximately 5 years
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Secondary outcome [10]
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Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)
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Assessment method [10]
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Time to deterioration (TTD) in pulmonary symptoms as measured by the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ). TTD is defined as time from randomization to the date of first deterioration.
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Timepoint [10]
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Up to approximately 5 years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/04/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
2/12/2030
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Actual
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Sample size
Target
830
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Hobart
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Recruitment hospital [2]
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Research Site - Woolloongabba
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Recruitment postcode(s) [1]
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7000 - Hobart
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment outside Australia
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Florida
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Japan
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State/province [112]
0
0
Osakasayama
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Country [113]
0
0
Japan
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State/province [113]
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0
Sakai-shi
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Country [114]
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0
Japan
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State/province [114]
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0
Sendai-shi
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Country [115]
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0
Japan
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State/province [115]
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0
Shinagawa-ku
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Country [116]
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Japan
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State/province [116]
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0
Toyoake-shi
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Country [117]
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Japan
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0
Toyonaka-shi
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Country [118]
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Korea, Republic of
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Jinju-si
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Malaysia
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Kuala Lumpur
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Malaysia
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Perai
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Malaysia
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Selangor
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Portugal
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State/province [122]
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Alcabideche
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Portugal
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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
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Bucuresti
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Romania
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Craiova
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Romania
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Iasi
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Country [129]
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Romania
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State/province [129]
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Pitesti
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Spain
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Badalona
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Spain
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Castellón
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Spain
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Granada
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Oviedo
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Turkey
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Bakirkoy
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Turkey
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Izmit
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Turkey
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Yüregir
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United Kingdom
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Blackpool
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Country [140]
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United Kingdom
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Hull
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Country [141]
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United Kingdom
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Stevenage
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06868277
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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AstraZeneca Clinical Study Information Center
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Address
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Phone
0
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1-877-240-9479
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Email
0
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[email protected]
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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
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