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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04619797




Registration number
NCT04619797
Ethics application status
Date submitted
30/10/2020
Date registered
6/11/2020

Titles & IDs
Public title
A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer
Scientific title
A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Patients With Previously Untreated Advanced Non-Squamous Non-Small-Cell Lung Cancer
Secondary ID [1] 0 0
2020-002851-39
Secondary ID [2] 0 0
BO42592
Universal Trial Number (UTN)
Trial acronym
SKYSCRAPER-06
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tiragolumab
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Tiragolumab Matching Placebo
Treatment: Drugs - Pembrolizumab

Experimental: Tiragolumab+Atezolizumab+Pemetrexed+Carboplatin or Cisplatin - Induction treatment with tiragolumab in combination with atezolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with tiragolumab in combination with atezolizumab and pemetrexed on Day 1 of each 21-day cycle.

Placebo comparator: Placebo+Pembrolizumab+Pemetrexed+Carboplatin or Cisplatin - Induction treatment with placebo in combination with pembrolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with placebo in combination with pembrolizumab and pemetrexed on Day 1 of each 21-day cycle.


Treatment: Drugs: Tiragolumab
Tiragolumab at a fixed dose of 600 milligrams (mg), administered by intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

Treatment: Drugs: Atezolizumab
Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.

Treatment: Drugs: Pemetrexed
Pemetrexed 500 milligrams per square meter (mg/m\^2), administered by IV infusion, Q3W on Day 1 of each 21-day cycle.

Treatment: Drugs: Carboplatin
Carboplatin at dose of area under the concentration-time curve (AUC) of 5, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.

Treatment: Drugs: Cisplatin
Cisplatin 75 mg/m\^2, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.

Treatment: Drugs: Tiragolumab Matching Placebo
Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.

Treatment: Drugs: Pembrolizumab
Pembrolizumab at a fixed dose of 200 mg, administered by IV infusion, Q3W, on Day 1 of each 21-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Investigator-Assessed Confirmed Objective Response Rate (ORR) (Phase 2)
Timepoint [1] 0 0
Up to approximately 5 years
Primary outcome [2] 0 0
Investigator-Assessed Progression-Free Survival (PFS) (Phase 2 and Phase 3)
Timepoint [2] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 5 years [Phase 2], up to approximately 7 years [Phase 3])
Primary outcome [3] 0 0
Overall Survival (Phase 3)
Timepoint [3] 0 0
From randomization to death from any cause (up to approximately 7 years)
Secondary outcome [1] 0 0
Overall Survival (Phase 2)
Timepoint [1] 0 0
From randomization to death from any cause (up to approximately 5 years)
Secondary outcome [2] 0 0
PFS as Determined by an Independent Review Facility (IRF) (Phase 3)
Timepoint [2] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 7 years)
Secondary outcome [3] 0 0
Investigator-assessed PFS in Participants With PD-L1 Expression at TC =50% and TC =1% Cut-off, as Determined by Central Testing With Ventana PD-L1 (SP263) Assay (Phase 3)
Timepoint [3] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 7 years)
Secondary outcome [4] 0 0
OS in Participants With PD-L1 Expression at TC =50% and TC =1% Cut-off, as Determined by Central Testing With Ventana PD-L1 (SP263) Assay (Phase 3)
Timepoint [4] 0 0
From randomization to death from any cause (up to approximately 7 years)
Secondary outcome [5] 0 0
Investigator-Assessed PFS at 6 Months and 12 Months (Phase 3)
Timepoint [5] 0 0
6 months, 12 months
Secondary outcome [6] 0 0
OS Rate at 12 Months and 24 Months (Phase 3)
Timepoint [6] 0 0
12 months, 24 months
Secondary outcome [7] 0 0
Investigator-Assessed Confirmed ORR (Phase 3)
Timepoint [7] 0 0
Up to approximately 7 years
Secondary outcome [8] 0 0
Investigator-Assessed Duration of Response (DOR) (Phase 2 and Phase 3)
Timepoint [8] 0 0
From first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 5 years [Phase 2]; up to approximately 7 years [Phase 3])
Secondary outcome [9] 0 0
Time to Confirmed Deterioration (TTCD) in Participant-Reported Physical Functioning and Global Health Status (GHS)/Quality of Life (QoL) as Measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (Phase 2 and Phase 3)
Timepoint [9] 0 0
Up to approximately 5 years (Phase 2); up to approximately 7 years (Phase 3)
Secondary outcome [10] 0 0
TTCD in Participant-Reported Lung Cancer Symptoms for Cough, Dyspnea, and Chest Pain, as Measured by EORTC QLQ-LC13 (Phase 2 and Phase 3)
Timepoint [10] 0 0
Up to approximately 5 years (Phase 2); up to approximately 7 years (Phase 3)
Secondary outcome [11] 0 0
Percentage of Participants With Adverse Events (AEs) (Phase 2 and Phase 3)
Timepoint [11] 0 0
Up to approximately 5 years (Phase 2); up to approximately 7 years (Phase 3)
Secondary outcome [12] 0 0
Participants' Response to Side Effects of Treatment as Assessed by EORTC IL46 (Phase 2 and Phase 3)
Timepoint [12] 0 0
Up to approximately 5 years (Phase 2); up to approximately 7 years (Phase 3)
Secondary outcome [13] 0 0
Serum Concentration of Tiragolumab (Phase 2 and Phase 3)
Timepoint [13] 0 0
Cycle 1 (each cycle=21 days), Day 1: predose, 0.5 hour (h) postdose; Cycles 2, 3, 4, 8, 12, 16, Day 1: predose and at treatment discontinuation (TD) visit (up to approximately 5 years [Phase 2]; up to approximately 7 years [Phase 3])
Secondary outcome [14] 0 0
Serum Concentration of Atezolizumab (Phase 2 and Phase 3)
Timepoint [14] 0 0
Cycle 1 (each cycle=21 days), Day 1: predose, 0.5 hour (h) postdose; Cycles 2, 3, 4, 8, 12, 16, Day 1: predose and at TD visit (up to approximately 5 years [Phase 2]; up to approximately 7 years [Phase 3])
Secondary outcome [15] 0 0
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab (Phase 2 and Phase 3)
Timepoint [15] 0 0
Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12, 16 and at TD visit (up to approximately 5 years [Phase 2]; up to approximately 7 years [Phase 3])
Secondary outcome [16] 0 0
Percentage of Participants With ADAs to Atezolizumab (Phase 2 and Phase 3)
Timepoint [16] 0 0
Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12, 16 and at TD visit (up to approximately 5 years [Phase 2]; up to approximately 7 years [Phase 3])

Eligibility
Key inclusion criteria
Key

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
* No prior systemic treatment for metastatic non-squamous NSCLC
* Known tumor programmed death-ligand 1 (PD-L1) status
* Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
* Life expectancy >= 12 weeks
* Adequate hematologic and end-organ function
* Negative human immunodeficiency virus (HIV) test at screening
* Serology test negative for active hepatitis B virus or active hepatitis C virus at screening.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Mutations in epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) fusion oncogene
* Pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* 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 randomization, with the exception of malignancies with a negligible risk of metastasis or death
* Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
* 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-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
* Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
* Known allergy or hypersensitivity or other contraindication to any component of the chemotherapy regimen the participant may receive during the study
* Women who are pregnant, or breastfeeding
* Known targetable c-ROS oncogene 1 (ROS1) or BRAFV600E genomic aberration.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/05/2027
Actual
Sample size
Target
Accrual to date
Final
542
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
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Indiana
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United States of America
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Kansas
Country [6] 0 0
United States of America
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Kentucky
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United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Belgium
State/province [10] 0 0
Aalst
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
Country [12] 0 0
Belgium
State/province [12] 0 0
Mont-godinne
Country [13] 0 0
Belgium
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Sint Niklaas
Country [14] 0 0
Brazil
State/province [14] 0 0
CE
Country [15] 0 0
Brazil
State/province [15] 0 0
RS
Country [16] 0 0
Brazil
State/province [16] 0 0
SP
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
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Canada
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Quebec
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China
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Beijing
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China
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Changchun
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China
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Changsha City
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China
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Changzhou
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China
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Chengde City
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China
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Chengdu City
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China
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Dongguan
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China
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Hefei
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China
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Jinan City
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China
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Linyi City
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China
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Pingxiang City
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China
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Qingdao City
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China
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Weifang City
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China
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Wuhan
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China
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Xi'an City
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China
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Xinxiang City
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China
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Zhengzhou
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Denmark
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København Ø
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Denmark
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Odense C
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Denmark
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Roskilde
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France
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Bordeaux
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France
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Marseille cedex 20
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France
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Rennes
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France
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Strasbourg
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France
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Toulouse cedex 9
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Germany
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Berlin
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Germany
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Chemnitz
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Germany
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Karlsruhe
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Germany
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Mainz
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Germany
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Marburg
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Hong Kong
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Hong Kong
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Hong Kong
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Shatin
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Italy
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Emilia-Romagna
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Italy
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Friuli-Venezia Giulia
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Toscana
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Japan
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Fukuoka
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Japan
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Hiroshima
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Japan
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Hyogo
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Japan
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Kyoto
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Japan
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Miyagi
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tokyo
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Japan
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Wakayama
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Korea, Republic of
State/province [66] 0 0
Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Gyeongsangnam-do
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Korea, Republic of
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Seoul
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Mexico
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Mexico CITY (federal District)
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Mexico
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Queretaro
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Mexico
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SAN LUIS Potosi
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Mexico
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Ciudad de México
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New Zealand
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Auckland
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New Zealand
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Hamilton
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New Zealand
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Palmerston North
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New Zealand
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Tauranga
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Poland
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?ód?
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Poland
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Olsztyn
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Spain
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Barcelona
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Spain
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Islas Baleares
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Spain
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LA Coruña
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Spain
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LAS Palmas
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Spain
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Lugo
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Switzerland
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Aarau
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Switzerland
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Chur
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Switzerland
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Zürich
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Taiwan
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Chang Hua
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Taiwan
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Taichung
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Taiwan
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Taipei City
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Thailand
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Bangkok
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Thailand
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ChiangMai
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Thailand
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Songkhla
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Diyarbakir
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Turkey
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Edirne
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Turkey
State/province [103] 0 0
Istanbul
Country [104] 0 0
Turkey
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Kadiköy
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Cornwall
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United Kingdom
State/province [106] 0 0
Hull
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United Kingdom
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London
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Nottingham
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT04619797