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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05984277
Registration number
NCT05984277
Ethics application status
Date submitted
2/08/2023
Date registered
9/08/2023
Titles & IDs
Public title
A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.
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Scientific title
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).
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Secondary ID [1]
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2023-000056-38
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Secondary ID [2]
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D798AC00001
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Universal Trial Number (UTN)
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Trial acronym
eVOLVE-Lung02
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Cancer
0
0
0
0
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Lung - Mesothelioma
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Cancer
0
0
0
0
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Lung - Non small cell
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Cancer
0
0
0
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 - Volrustomig
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Pemetrexed
Experimental: Arm 1 - Volrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
Active comparator: Arm 2 - Pembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
Treatment: Drugs: Volrustomig
Volrustomig
Treatment: Drugs: Pembrolizumab
Pembrolizumab
Treatment: Drugs: Carboplatin
Carboplatin
Treatment: Drugs: Paclitaxel
Paclitaxel
Treatment: Drugs: Pemetrexed
Pemetrexed
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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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Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 6 years
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Primary outcome [2]
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Overall Survival (OS), in PD-L1-negative participants.
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Assessment method [2]
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OS is defined as the time from randomization until the date of death due to any cause, in PD-L1-negative participants.
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Timepoint [2]
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Up to approximately 6 years
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Secondary outcome [1]
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PFS (using BICR assessments according to RECIST 1.1)
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Assessment method [1]
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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). The analysis will include all randomized participants.
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Timepoint [1]
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Up to approximately 6 years
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Secondary outcome [2]
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OS
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Assessment method [2]
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OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants.
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Timepoint [2]
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Up to approximately 6 years
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Secondary outcome [3]
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PFS (using Investigator assessments according to RECIST 1.1)
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Assessment method [3]
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PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by investigator, or death due to any cause (in the absence of progression).
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Timepoint [3]
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Up to approximately 6 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 CR or confirmed PR, as determined by BICR assessments using RECIST 1.1.
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Timepoint [4]
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Up to approximately 6 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 per BICR assessments using RECIST 1.1 or death due to any cause (in the absence of progression). These analyses will include participants who have a confirmed response.
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Timepoint [5]
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Up to approximately 6 years
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Secondary outcome [6]
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PFS2
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Assessment method [6]
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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) after the start of the first subsequent therapy, or death. The date of second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice.
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Timepoint [6]
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Up to approximately 6 years
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Secondary outcome [7]
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Concentration of volrustomig in serum and PK parameters
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Assessment method [7]
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To assess the PK of volrustomig
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Timepoint [7]
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Up to approximately 6 years
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Secondary outcome [8]
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Presence of ADAs against volrustomig in serum
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Assessment method [8]
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To investigate the immunogenicity of volrustomig.
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Timepoint [8]
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Up to approximately 6 years
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Secondary outcome [9]
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Time-To-Deterioration (TTD) in physical functioning
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Assessment method [9]
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To assess participant-reported physical functioning in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.
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Timepoint [9]
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Up to approximately 6 years
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Secondary outcome [10]
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TTD of lung cancer symptoms
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Assessment method [10]
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To assess participant-reported pulmonary symptoms of mNSCLC in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.
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Timepoint [10]
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Up to approximately 6 years
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Eligibility
Key inclusion criteria
Key
* 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.
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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
* 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 whole brain radiotherapy and study enrollment.
* History of another primary malignancy except for:
1. 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.
2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
3. 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.
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
24/10/2023
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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
16/05/2029
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Actual
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Sample size
Target
900
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Accrual to date
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Final
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Recruitment in Australia
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Recruitment hospital [1]
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Research Site - Clayton
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Research Site - Fitzroy
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Research Site - South Brisbane
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Research Site - Sydney
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3168 - Clayton
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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4101 - South Brisbane
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Recruitment postcode(s) [5]
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NSW 2145 - Sydney
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Country [113]
0
0
Japan
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State/province [113]
0
0
Bunkyo-ku
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Country [114]
0
0
Japan
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State/province [114]
0
0
Fukuoka-shi
Query!
Country [115]
0
0
Japan
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State/province [115]
0
0
Kashiwa
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Country [116]
0
0
Japan
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State/province [116]
0
0
Kawasaki-shi
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Country [117]
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0
Japan
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State/province [117]
0
0
Koto-ku
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Country [118]
0
0
Japan
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State/province [118]
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0
Nagoya-shi
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Country [119]
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0
Japan
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State/province [119]
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0
Osakasayama-shi
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Country [120]
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0
Japan
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State/province [120]
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0
Sendai-shi
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Country [121]
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0
Japan
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State/province [121]
0
0
Ube-shi
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Country [122]
0
0
Japan
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State/province [122]
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0
Yokohama-shi
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Country [123]
0
0
Korea, Republic of
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State/province [123]
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0
Cheongju-si
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Country [124]
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Korea, Republic of
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State/province [124]
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Incheon
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Country [125]
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0
Korea, Republic of
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State/province [125]
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Jinju-si
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Country [126]
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Korea, Republic of
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Seoul
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Country [127]
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Korea, Republic of
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Suwon-si
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Korea, Republic of
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Suwon
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0
0
Mexico
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State/province [129]
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Ciudad de México
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Country [130]
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Mexico
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State/province [130]
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Culiacan
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Country [131]
0
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Mexico
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Guadalajara
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Country [132]
0
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Mexico
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State/province [132]
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Mexico City
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Country [133]
0
0
Mexico
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State/province [133]
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0
Monterrey
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Country [134]
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0
Mexico
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State/province [134]
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0
Naucalpan
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Country [135]
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0
Netherlands
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0
Amsterdam
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0
Netherlands
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Groningen
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Netherlands
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Nieuwegein
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0
Netherlands
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0
0
Tilburg
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Country [139]
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0
Poland
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Lublin
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Country [140]
0
0
Poland
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State/province [140]
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Poznan
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Country [141]
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0
Poland
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State/province [141]
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0
Przemysl
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Country [142]
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0
Poland
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State/province [142]
0
0
Rzeszów
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Country [143]
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0
Poland
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State/province [143]
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Szklarska Poreba
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Country [144]
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Poland
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State/province [144]
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0
Tomaszów Mazowiecki
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Country [145]
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0
Poland
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State/province [145]
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Torun
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Country [146]
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0
Poland
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State/province [146]
0
0
Warszawa
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Country [147]
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0
Poland
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State/province [147]
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Lódz
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Country [148]
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0
Slovakia
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State/province [148]
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Banska Bystrica
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Country [149]
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0
Slovakia
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State/province [149]
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Bratislava
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Country [150]
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Slovakia
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State/province [150]
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Kosice
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Slovakia
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State/province [151]
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Trnava
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Country [152]
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0
South Africa
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State/province [152]
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0
Amanzimtoti
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Country [153]
0
0
South Africa
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State/province [153]
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0
Bloemfontein
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0
0
South Africa
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State/province [154]
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George
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Country [155]
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0
South Africa
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State/province [155]
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0
Johannesburg
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Country [156]
0
0
South Africa
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Parktown
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Country [157]
0
0
South Africa
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State/province [157]
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0
Pietermaritzburg
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Country [158]
0
0
South Africa
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State/province [158]
0
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Pretoria
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Country [159]
0
0
South Africa
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State/province [159]
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0
Rondebosch
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Country [160]
0
0
South Africa
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State/province [160]
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0
Soweto
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Country [161]
0
0
Spain
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State/province [161]
0
0
Alicante
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Country [162]
0
0
Spain
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State/province [162]
0
0
Barcelona
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Country [163]
0
0
Spain
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State/province [163]
0
0
Bilbao (Vizcaya)
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Country [164]
0
0
Spain
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State/province [164]
0
0
Madrid
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Country [165]
0
0
Spain
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State/province [165]
0
0
Málaga
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Country [166]
0
0
Spain
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State/province [166]
0
0
Palma
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Country [167]
0
0
Taiwan
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State/province [167]
0
0
Hsinchu
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Country [168]
0
0
Taiwan
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State/province [168]
0
0
Kaohsiung
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Country [169]
0
0
Taiwan
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State/province [169]
0
0
Tainan
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Country [170]
0
0
Taiwan
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State/province [170]
0
0
Taipei City
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Country [171]
0
0
Taiwan
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State/province [171]
0
0
Taipei
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Country [172]
0
0
Taiwan
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State/province [172]
0
0
Yunlin
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Country [173]
0
0
Thailand
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State/province [173]
0
0
Lampang
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Country [174]
0
0
Thailand
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State/province [174]
0
0
Muang
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Country [175]
0
0
Thailand
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State/province [175]
0
0
Songkhla
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Country [176]
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0
Turkey
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State/province [176]
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Ankara
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Country [177]
0
0
Turkey
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State/province [177]
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Antalya
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Country [178]
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Turkey
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State/province [178]
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0
Diyarbakir
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Country [179]
0
0
Turkey
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0
0
Istanbul
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Country [180]
0
0
Turkey
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0
Izmir
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Country [181]
0
0
Turkey
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State/province [181]
0
0
Pamukkale
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Country [182]
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0
Turkey
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State/province [182]
0
0
Çankaya
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Country [183]
0
0
United Kingdom
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State/province [183]
0
0
Birmingham
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Country [184]
0
0
United Kingdom
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State/province [184]
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0
Blackpool
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Country [185]
0
0
United Kingdom
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State/province [185]
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0
Bury St Edmunds
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Country [186]
0
0
United Kingdom
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State/province [186]
0
0
Colchester
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Country [187]
0
0
United Kingdom
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0
0
London
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Country [188]
0
0
United Kingdom
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State/province [188]
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0
Truro
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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
Query!
Summary
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%.
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Trial website
https://clinicaltrials.gov/study/NCT05984277
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
AstraZeneca Clinical Study Information Center
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-877-240-9479
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Fax
0
0
Query!
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 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.
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 EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer 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 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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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/NCT05984277