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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06692738
Registration number
NCT06692738
Ethics application status
Date submitted
4/10/2024
Date registered
18/11/2024
Date last updated
13/06/2025
Titles & IDs
Public title
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
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Scientific title
A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)
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Secondary ID [1]
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2024-514281-39-00
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Secondary ID [2]
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D702BC00001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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0
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Lung - Non small cell
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Cancer
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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: Drugs - Rilvegostomig
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Nab-paclitaxel
Experimental: Arm A - Rilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig
Active comparator: Arm B - Pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab
Treatment: Drugs: Rilvegostomig
Administered intravenously (IV) on Day 1 of each 21-day cycle
Treatment: Drugs: Pembrolizumab
Administered intravenously (IV) on Day 1 of each 21-day cycle
Treatment: Drugs: Carboplatin
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Treatment: Drugs: Paclitaxel
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Treatment: Drugs: Nab-paclitaxel
Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles
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Intervention code [1]
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Treatment: Drugs
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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 Response Evaluation Criteria in Solid Tumors, Version 1.1 (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 Response Evaluation Criteria in Solid Tumors, Version 1.1 (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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Time to second progression or death (PFS2)
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Assessment method [3]
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PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first. The date of the second progression will be recorded by the investigator in the electronic Case Report Form (eCRF) and defined according to local standard clinical practice.
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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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Overall response rate (ORR)
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Assessment method [4]
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ORR is defined as the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR), by using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
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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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Duration of response (DoR)
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Assessment method [5]
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DoR is defined as the time from the date of first documented response until the date of documented progression using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression).
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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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Pharmacokinetic (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. Deterioration is defined as a worsening change from baseline that reaches a clinically meaningful change threshold.
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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 squamous NSCLC.
* Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
* Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any actionable driver oncogenes for which there are locally approved targeted 1L therapies.
* Provision of acceptable tumor sample to confirm tumor PD-L1 expression TC = 1%.
* At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as = 10 mm in the longest diameter (except lymph nodes, which must have short axis = 15 mm) with CT or MRI and is suitable for accurate repeated measurements.
* Adequate organ and bone marrow function.
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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
* Presence of small cell and neuroendocrine histology components.
* Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.
* Any prior systemic therapy received for advanced or mNSCLC.
* Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
* Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease = 2 years before the first dose of study intervention and of low potential risk for recurrence.
* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
* Active primary immunodeficiency/active infectious disease(s).
* Active tuberculosis infection.
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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
18/11/2024
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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
8/10/2029
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Actual
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Sample size
Target
880
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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 - Darlinghurst
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Recruitment hospital [2]
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Research Site - Hyde Park
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Recruitment hospital [3]
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Research Site - Southport
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Recruitment hospital [4]
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Research Site - Wollongong
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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4812 - Hyde Park
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Recruitment postcode(s) [3]
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4215 - Southport
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Recruitment postcode(s) [4]
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2500 - Wollongong
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Recruitment outside Australia
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Connecticut
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Delaware
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Londrina
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Beijing
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Changchun
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Changde
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Changsha
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Chongqing
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Dalian
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Guangzhou
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Hangzhou
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Harbin
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Yangzhou
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Zhengzhou
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Avignon
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Nimes
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Rennes
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Toulon Cedex 9
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Germany
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Bad Berka
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Berlin
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Esslingen
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Frankfurt
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Gauting
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Giessen
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Großhansdorf
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Hemer
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Germany
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Moers
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Germany
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München
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Germany
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Regensburg
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Germany
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Würzburg
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Gyöngyös
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Hungary
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Gyor
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Hungary
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Pécs
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Hungary
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Székesfehérvár
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Hungary
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Törökbálint
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India
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Calicut
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India
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Delhi
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India
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Kolkata
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India
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Madurai
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India
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Mumbai
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India
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Nashik
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India
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New Delhi
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India
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Pondicherry
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India
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Surat
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India
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Varanasi
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Italy
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Firenze
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Italy
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Monza
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Italy
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Orbassano
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Italy
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Padova
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Italy
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Peschiera Del Garda
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Italy
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Roma
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Japan
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Amagasaki-shi
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Japan
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Bunkyo-ku
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Japan
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Chuo-ku
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Japan
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Fukuoka-shi
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Japan
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Hiroshima-shi
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Japan
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Kawagoe-shi
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Japan
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Kitaadachi-gun
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Japan
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Kobe-shi
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Japan
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Koto-ku
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Japan
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Shinjuku-ku
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Japan
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Yokohama-shi
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Korea, Republic of
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Cheongju-si
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Incheon
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Seoul
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Malaysia
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Kuala Lumpur
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Alkmaar
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Ede
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Groningen
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Leidschendam
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Veldhoven
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Zwolle
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Peru
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Lima
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Biala Podlaska
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Bystra
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Barcelona
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Lérida
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Spain
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Madrid
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Spain
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Taichung
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Taoyuan
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Bangkok
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Dusit
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Thailand
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Nakhon Ratchasima
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Thailand
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Songkla
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Turkey
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Antalya
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Turkey
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Istanbul
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Turkey
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Yenimahalle
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United Kingdom
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Aberdeen
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Cambridge
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Edinburgh
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Exeter
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United Kingdom
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Greater London
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London
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Manchester
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Preston
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Can Tho
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Hanoi
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Ho Chi Minh
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Vietnam
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Vinh
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).
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Trial website
https://clinicaltrials.gov/study/NCT06692738
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
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Address
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Fax
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Email
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Contact person for public queries
Name
0
0
AstraZeneca Clinical Study Information Center
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Address
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0
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Country
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Phone
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0
1-877-240-9479
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Fax
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca (AZ) group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for Important Protocol Deviation (IPD), but this does not mean all requests will be approved.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the European Federation of Pharmaceutical Industries and Associations (EFPIA)/Pharmaceutical Research and Manufacturers of America (PhRMA) Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Query!
Available to whom?
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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/
Query!
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/NCT06692738
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