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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04513925
Registration number
NCT04513925
Ethics application status
Date submitted
13/08/2020
Date registered
14/08/2020
Date last updated
24/05/2024
Titles & IDs
Public title
A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)
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Scientific title
A Phase III, Open-Label, Randomized Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Patients With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent Platinum-Based Chemoradiation
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Secondary ID [1]
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2019-004773-29
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Secondary ID [2]
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GO41854
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Universal Trial Number (UTN)
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Trial acronym
SKYSCRAPER-03
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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 (NSCLC)
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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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 - Atezolizumab
Treatment: Drugs - Tiragolumab
Treatment: Drugs - Durvalumab
Experimental: Atezolizumab + Tiragolumab - Participants will receive atezolizumab administered intravenously (IV) on Day 1 of each 28-day cycle followed by tiragolumab administered IV on Day 1 of each 28-day cycle for a maximum of 13 cycles.
Active Comparator: Durvalumab - Participants will receive durvalumab administered IV during each 28-day cycle for a maximum of 13 cycles.
Treatment: Drugs: Atezolizumab
Atezolizumab 1680 mg every 4 weeks (Q4W) will be administered IV on Day 1 of each 28-day cycle.
Treatment: Drugs: Tiragolumab
Tiragolumab 840 mg Q4W will be administered IV on Day 1 of each 28-day cycle.
Treatment: Drugs: Durvalumab
Durvalumab will be administered based on weight at 10 mg/kg IV every 2 weeks (Q2W) on Days 1 and 15 of each 28-day cycle, or will be administered at a fixed dose of 1500 mg IV every 4 weeks (Q4W) (for participants whose weight >/= 30 kg) on Day 1 of each 28-day cycle.
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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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Independent Review Facility (IRF)-assessed Progression Free Survival (PFS) in the PD-L1-positive Analysis Set (PPAS)
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Assessment method [1]
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Timepoint [1]
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From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
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Primary outcome [2]
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IRF-assessed PFS in the Full Analysis Set (FAS)
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Assessment method [2]
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Timepoint [2]
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From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
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Secondary outcome [1]
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Overall Survival (OS) in the PPAS
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Assessment method [1]
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Timepoint [1]
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From randomization to death from any cause (up to approximately 114 months)
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Secondary outcome [2]
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Investigator-assessed PFS in the PPAS
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Assessment method [2]
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Timepoint [2]
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Time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first first (up to approximately 114 months)
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Secondary outcome [3]
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IRF-assessed Confirmed Objective Response Rate (ORR) in the PPAS
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Assessment method [3]
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Timepoint [3]
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From randomization up to approximately 114 months
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Secondary outcome [4]
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Investigator-assessed Confirmed ORR in the PPAS
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Assessment method [4]
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Timepoint [4]
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From randomization up to approximately 114 months
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Secondary outcome [5]
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IRF-assessed Duration of Response (DOR) in the PPAS
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Assessment method [5]
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Timepoint [5]
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From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
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Secondary outcome [6]
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Investigator-assessed DOR in the PPAS
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Assessment method [6]
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Timepoint [6]
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From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
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Secondary outcome [7]
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Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score in the PPAS
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Assessment method [7]
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TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS) and physical functioning from baseline that must be held for all subsequent assessment timepoints or followed by death attributable to cancer progression. EORTC QLQ-C30: a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting and pain), GHS and quality of life (QoL), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) with a recall period of the previous week. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with higher score indicating worse outcome. Symptom items (GHS and QoL) are scored on a 7-point scale: 1=Very poor to 7=Excellent. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. Higher score indicates better outcome.
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Timepoint [7]
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Up to approximately 114 months
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Secondary outcome [8]
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OS in the FAS
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Assessment method [8]
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Timepoint [8]
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From randomization to death from any cause (up to approximately 114 months)
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Secondary outcome [9]
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Investigator-assessed PFS in the FAS
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Assessment method [9]
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Timepoint [9]
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Time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first first (up to approximately 114 months)
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Secondary outcome [10]
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IRF-assessed Confirmed ORR in the FAS
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Assessment method [10]
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0
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Timepoint [10]
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From randomization up to approximately 114 months
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Secondary outcome [11]
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Investigator-assessed Confirmed ORR in the FAS
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Assessment method [11]
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Timepoint [11]
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From randomization up to approximately 114 months
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Secondary outcome [12]
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IRF-assessed DOR in the FAS
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Assessment method [12]
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Timepoint [12]
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From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
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Secondary outcome [13]
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Investigator-assessed DOR in the FAS
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Assessment method [13]
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Timepoint [13]
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From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
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Secondary outcome [14]
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TTCD Assessed Using EORTC QLQ-C30 Score in the FAS
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Assessment method [14]
0
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TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS) and physical functioning from baseline that must be held for all subsequent assessment timepoints or followed by death attributable to cancer progression. EORTC QLQ-C30: a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting and pain), GHS and quality of life (QoL), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) with a recall period of the previous week. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with higher score indicating worse outcome. Symptom items (GHS and QoL) are scored on a 7-point scale: 1=Very poor to 7=Excellent. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. Higher score indicates better outcome.
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Timepoint [14]
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Up to approximately 114 months
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Secondary outcome [15]
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IRF-assessed PFS Rates at 12 Months, 18 Months and 24 Months in the PPAS
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Assessment method [15]
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Timepoint [15]
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12, 18 and 24 months
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Secondary outcome [16]
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IRF-assessed PFS Rates at 12 Months, 18 Months and 24 Months in the FAS
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Assessment method [16]
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Timepoint [16]
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12, 18 and 24 months
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Secondary outcome [17]
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Investigator-assessed PFS Rates at 12 Months, 18 Months and 24 Months in the PPAS
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Assessment method [17]
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Timepoint [17]
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12, 18 and 24 months
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Secondary outcome [18]
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Investigator-assessed PFS Rates at 12 Months, 18 Months and 24 Months in the FAS
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Assessment method [18]
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Timepoint [18]
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12, 18 and 24 months
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Secondary outcome [19]
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OS Rates at 12 Months, 24 Months, 36 Months and 48 Months in the PPAS
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Assessment method [19]
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Timepoint [19]
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12, 24, 36 and 48 months
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Secondary outcome [20]
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OS Rates at 12 Months, 24 Months, 36 Months and 48 Months in the FAS
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Assessment method [20]
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0
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Timepoint [20]
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12, 24, 36 and 48 months
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Secondary outcome [21]
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Investigator-assessed Time to Death or Distant Metastasis (TTDM) in the PPAS
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Assessment method [21]
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Timepoint [21]
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From randomization until the first date of distant metastasis or death in the absence of distant metastasis (up to approximately 114 months)
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Secondary outcome [22]
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Investigator-assessed TTDM in the FAS
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Assessment method [22]
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Timepoint [22]
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From randomization until the first date of distant metastasis or death in the absence of distant metastasis (up to approximately 114 months)
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Secondary outcome [23]
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Percentage of Participants With Adverse Events
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Assessment method [23]
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Timepoint [23]
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Up to approximately 114 months
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Eligibility
Key inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically or cytologically documented NSCLC with locally advanced, unresectable
Stage III NSCLC of either squamous or non-squamous histology
- Whole-body Positron Emission Tomography-Computed Tomography (PET-CT) scan, performed
prior and within 42 days of the first dose of concurrent chemoradiotherapy (cCRT)
- At least two prior cycles of platinum-based chemotherapy administered concurrently
with radiotherapy (RT), which must be completed within 1 to 42 days prior to
randomization in the study (one cycle of cCRT is defined as 21 or 28 days)
- The radiotherapy (RT) component in the cCRT must have been at a total dose of
radiation of 60 (±10 percent [%]) gray (Gy) (54 Gy to 66 Gy) administered by intensity
modulated RT (preferred) or 3D-conforming technique
- No progression during or following concurrent platinum-based CRT
- A known PD-L1 result
- Life expectancy >/= 12 weeks
- Adequate hematologic and end-organ function
- Female participants must be willing to avoid pregnancy for 90 days after the final
dose of tiragolumab and 5 months after the final dose of atezolizumab, or for 3 months
after the final dose of durvalumab
- Male participants must remain abstinent or use a condom during the treatment period
and for 90 days after the final dose of tiragolumab
- Male participants must not donate sperm during the treatment period and for 90 days
after the final dose of tiragolumab
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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
- Any history of prior NSCLC and/or any history of prior treatment for NSCLC
(participants must be newly diagnosed with unresectable Stage III disease)
- NSCLC known to have a mutation in the epidermal growth factor receptor (EGFR) gene or
an anaplastic lymphoma kinase (ALK) fusion oncogene
- Any evidence of Stage IV disease
- Treatment with sequential CRT for locally advanced NSCLC
- Participants with locally advanced NSCLC who have progressed during or after the
definitive cCRT prior to randomization
- Any Grade >2 unresolved toxicity from previous CRT
- Grade >= 2 pneumonitis from prior CRT
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or idiopathic pneumonitis or evidence of active pneumonitis
- History of malignancy other than NSCLC within 5 years prior to screening with the
exception of malignancies with a negligible risk of metastasis or death
- Prior allogeneic stem cell or solid organ transplantation
- Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV
infection at screening
- Treatment with investigational therapy within 28 days prior to initiation of study
treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including
anti-cytotoxic T lymphocyte-associated protein 4, anti-T-cell immunoreceptor with Ig
and ITIM domains (anti-TIGIT), anti-PD-1 and anti-PD-L1
- Any prior Grade >/= 3 immune-mediated adverse event or any unresolved Grade > 1
immune-mediated adverse event while receiving any previous immunotherapy agent other
than immune checkpoint blockade agents
- Treatment with systemic immunosuppressive medication
- Women who are pregnant, or breastfeeding
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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
Active, not 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
24/08/2020
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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
30/12/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
829
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Recruitment hospital [1]
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Blacktown Hospital - Blacktown
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Recruitment hospital [2]
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Macarthur Cancer Therapy Centre - Campbelltown
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Recruitment hospital [3]
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St George Hospital; Cancer Care Centre - Kogarah
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Recruitment hospital [4]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [5]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [6]
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Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit - Bull Creek
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Recruitment hospital [7]
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Monash Health Translational Precinct; Clinical Trials Centre, Level 3 - Victoria
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2560 - Campbelltown
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment postcode(s) [5]
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5042 - Bedford Park
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Recruitment postcode(s) [6]
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6149 - Bull Creek
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Recruitment postcode(s) [7]
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3168 - Victoria
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Recruitment outside Australia
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United States of America
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State/province [1]
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Arizona
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United States of America
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Arkansas
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California
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Florida
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Georgia
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Illinois
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Maine
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Massachusetts
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Minnesota
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Missouri
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New Mexico
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New York
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Cordoba
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Rosario
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Austria
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Innsbruck
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Linz
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Charleroi
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Ontario
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Beijing
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Changchun
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China
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Changzhou
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China
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China
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Jinan
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China
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Nanjing
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China
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China
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Shantou
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China
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Wuhan
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China
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Xiamen
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China
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Xuzhou
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China
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Zhengzhou
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France
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Angers
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France
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Caen
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Marseille
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France
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France
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Vantoux
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France
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Villejuif cedex
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Germany
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Braunschweig
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Germany
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Göttingen
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Country [67]
0
0
Germany
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State/province [67]
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Heidelberg
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Country [68]
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Germany
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Köln
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Country [69]
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Germany
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State/province [69]
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München
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Country [70]
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Germany
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State/province [70]
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Regensburg
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Country [71]
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Greece
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State/province [71]
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Asvestochori
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Country [72]
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Greece
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Athens
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Country [73]
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Greece
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Heraklion
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Country [74]
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Greece
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Kifisia
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Country [75]
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Hong Kong
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Hong Kong
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Hong Kong
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State/province [76]
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Pokfulam
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Country [77]
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Hungary
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State/province [77]
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Pécs
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Country [78]
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Hungary
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Tatabánya
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Country [79]
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Hungary
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Torokbalint
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Country [80]
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Israel
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Beer Sheva
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Israel
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Haifa
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Country [82]
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Israel
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Jerusalem
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Country [83]
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Israel
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Petah Tikva
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Country [84]
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Italy
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Campania
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Country [85]
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Italy
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State/province [85]
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Emilia-Romagna
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Country [86]
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Italy
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State/province [86]
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Lazio
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Country [87]
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Italy
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State/province [87]
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Liguria
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Country [88]
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Italy
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State/province [88]
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Lombardia
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Country [89]
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Italy
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State/province [89]
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Toscana
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Country [90]
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Italy
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Veneto
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Country [91]
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Japan
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State/province [91]
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Aichi
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Country [92]
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Japan
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State/province [92]
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Chiba
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Country [93]
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Japan
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Hyogo
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Country [94]
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Japan
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State/province [94]
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Kanagawa
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Country [95]
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Japan
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Kyoto
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Country [96]
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Japan
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State/province [96]
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Miyagi
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Country [97]
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Japan
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State/province [97]
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Niigata
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Country [98]
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Japan
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State/province [98]
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Osaka
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Country [99]
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Japan
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Saitama
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Country [100]
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Japan
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Shizuoka
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Country [101]
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Japan
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Tokyo
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Japan
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State/province [102]
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Wakayama
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Country [103]
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Korea, Republic of
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State/province [103]
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Cheongju si
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Korea, Republic of
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State/province [104]
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Daegu
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Korea, Republic of
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State/province [105]
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Goyang-si
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Korea, Republic of
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State/province [106]
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Gyeonggi-do
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Korea, Republic of
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State/province [107]
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Gyeongsangnam-do
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Country [108]
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Korea, Republic of
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State/province [108]
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Incheon
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Country [109]
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Korea, Republic of
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State/province [109]
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Jeollanam-do
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Country [110]
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Korea, Republic of
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State/province [110]
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Seongnam-si
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Country [111]
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Korea, Republic of
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State/province [111]
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Seoul
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Country [112]
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Korea, Republic of
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State/province [112]
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Ulsan
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Netherlands
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State/province [113]
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Amersfoort
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Netherlands
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State/province [114]
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Breda
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Country [115]
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Netherlands
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State/province [115]
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Leidschendam
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Country [116]
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Netherlands
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Sittard-Geleen
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Country [117]
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New Zealand
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Auckland
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Country [118]
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Poland
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State/province [118]
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Gdansk
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Country [119]
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Poland
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State/province [119]
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Olsztyn
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Country [120]
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Poland
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State/province [120]
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Otwock
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Country [121]
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Poland
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State/province [121]
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Warszawa
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Country [122]
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Poland
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State/province [122]
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Wroc?aw
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Portugal
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State/province [123]
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Coimbra
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Country [124]
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Portugal
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State/province [124]
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Lisboa
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Country [125]
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Portugal
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State/province [125]
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Porto
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Country [126]
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Spain
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State/province [126]
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Barcelona
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Country [127]
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Spain
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Castellon
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Country [128]
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Spain
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State/province [128]
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Islas Baleares
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Country [129]
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Spain
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LA Coruña
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Country [130]
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Spain
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Madrid
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Country [131]
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Spain
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Malaga
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Country [132]
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Spain
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State/province [132]
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Sevilla
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Country [133]
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Taiwan
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State/province [133]
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Taichung
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Country [134]
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Taiwan
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State/province [134]
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Taipei
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Country [135]
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Thailand
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State/province [135]
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Bangkok
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Country [136]
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Thailand
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State/province [136]
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Songkhla
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Country [137]
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Turkey
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State/province [137]
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Adana
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Country [138]
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Turkey
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State/province [138]
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Ankara
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Country [139]
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Turkey
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State/province [139]
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0
Bornova, ?zm?r
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Country [140]
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Turkey
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State/province [140]
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Diyarbakir
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Country [141]
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Turkey
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State/province [141]
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Edirne
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Country [142]
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Turkey
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State/province [142]
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Istanbul
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Country [143]
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Turkey
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State/province [143]
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Malatya
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Country [144]
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0
United Kingdom
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State/province [144]
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Birmingham
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Country [145]
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0
United Kingdom
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Cambridge
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Country [146]
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United Kingdom
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Glasgow
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Country [147]
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United Kingdom
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State/province [147]
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Huddersfield
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Country [148]
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United Kingdom
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State/province [148]
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Leicester
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Country [149]
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United Kingdom
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State/province [149]
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Maidstone
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Country [150]
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United Kingdom
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State/province [150]
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Manchester
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Country [151]
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0
United Kingdom
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State/province [151]
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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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 this study is to evaluate the efficacy and safety of atezolizumab in
combination with tiragolumab compared with durvalumab in participants with locally advanced,
unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two
cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic
disease progression.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04513925
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Clinical Trials
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Address
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Hoffmann-La Roche
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04513925
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