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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02296125




Registration number
NCT02296125
Ethics application status
Date submitted
22/10/2014
Date registered
20/11/2014

Titles & IDs
Public title
AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Scientific title
A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer.
Secondary ID [1] 0 0
U1111-1160-2242
Secondary ID [2] 0 0
D5160C00007
Universal Trial Number (UTN)
Trial acronym
FLAURA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non Small Cell Lung Cancer 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 - AZD9291 80 mg/40 mg + placebo
Treatment: Drugs - Placebo Erlotinib 150/100mg
Treatment: Drugs - Placebo Gefitinib 250 mg
Treatment: Drugs - Erlotinib 150/100 mg
Treatment: Drugs - Gefitinib 250 mg
Treatment: Drugs - Placebo AZD9291 80 mg/ 40 mg

Experimental: AZD9291+ placebo - AZD9291 (80 mg or 40 mg orally, once daily) plus placebo Erlotinib (150mg or 100mg orally, once daily) or placebo Gefitinib (250 mg orally, once daily), in accordance with the randomization schedule.

Active comparator: Standard of Care + placebo AZD9291 - Erlotinib (150 mg or 100 mg orally, once daily) or placebo Gefitinib (250 mg orally, once daily) plus placebo AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomisation schedule.

Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were randomized to Standard of Care arm may have the option to receive open-label AZD9291 (crossover to active AZD9291).


Treatment: Drugs: AZD9291 80 mg/40 mg + placebo
The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment.

Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

Treatment: Drugs: Placebo Erlotinib 150/100mg
The initial dose of Placebo Erlotinib 150 mg once daily can be reduced to Placebo 100 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

Treatment: Drugs: Placebo Gefitinib 250 mg
The initial dose of Placebo Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

Treatment: Drugs: Erlotinib 150/100 mg
The initial dose of Erlotinib 150mg once daily can be reduced to 10 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment.

Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were randomized to Standard of Care arm may have the option to receive open-label AZD9291 (crossover to active AZD9291).

Treatment: Drugs: Gefitinib 250 mg
The initial dose of Gefitinib 250mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment.

Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were randomized to Standard of Care arm may have the option to receive open-label AZD9291 (crossover to active AZD9291).

Treatment: Drugs: Placebo AZD9291 80 mg/ 40 mg
The initial dose of Placebo AZD9291 80 mg once daily can be reduced to Placebo AZD9291 40 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Median Progression Free Survival (PFS) (Months)
Timepoint [1] 0 0
At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression
Primary outcome [2] 0 0
Percentage of Participants in Progression Free Survival at 6, 12, and 18 Months
Timepoint [2] 0 0
At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression
Secondary outcome [2] 0 0
Duration of Response (DoR)
Timepoint [2] 0 0
At baseline and every 6 weeks for the first 18 months and then every 12 weeks until objective disease progression
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Timepoint [3] 0 0
At baseline and every 6 weeks for the first 18 months and then every 12 weeks until objective disease progression
Secondary outcome [4] 0 0
Depth of Response
Timepoint [4] 0 0
At baseline and every 6 weeks for the first 18 months and then every 12 weeks until objective disease progression
Secondary outcome [5] 0 0
Overall Survival (OS)- Number of Participants With an Event
Timepoint [5] 0 0
From first dose to end of study or date of death from any cause, whichever comes first, assessed every 6 weeks (approximately 29 months)
Secondary outcome [6] 0 0
Plasma Concentrations of AZD9291
Timepoint [6] 0 0
Blood samples collected from each participant at pre-dose, 0.5 to 2 hours, and 3 to 5 hours post-dose on Day 1 Cycle 1, and every other cycle thereafter up to and including Cycle 13 (approximately 9 months)
Secondary outcome [7] 0 0
Plasma Concentrations of Metabolites AZ5104
Timepoint [7] 0 0
Blood samples collected from each participant at pre-dose, 0.5 to 2 hours, and 3 to 5 hours post-dose on Day 1 Cycle 1, and every other cycle thereafter up to and including Cycle 13 (approximately 9 months)
Secondary outcome [8] 0 0
Plasma Concentrations of Metabolite AZ7550
Timepoint [8] 0 0
Blood samples collected from each participant at pre-dose, 0.5 to 2 hours, and 3 to 5 hours post-dose on Day 1 Cycle 1, and every other cycle thereafter up to and including Cycle 13 (approximately 9 months)
Secondary outcome [9] 0 0
Participants Reported Outcome by Cancer Therapy Satisfaction Questionnaire 16 Items (CTSQ-16 Questionnaire)
Timepoint [9] 0 0
Questionnaire completed in cycle 2 and 3, prior to Week 6 scan (approximately 2 months)
Secondary outcome [10] 0 0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) Questionnaires Lung Cancer 13 (QLQ-LC13)
Timepoint [10] 0 0
Questionnaires completed at baseline, first 9 months, and at week 1, 2, 3, 4, 5, 6, 12, 18, 24, 30 and 36
Secondary outcome [11] 0 0
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30)
Timepoint [11] 0 0
Questionnaires completed at baseline, first 9 months, and at week 6, 12, 18, 24, 30, and 36.

Eligibility
Key inclusion criteria
1. Male or female, aged at least 18 years.
2. Pathologically confirmed adenocarcinoma of the lung.
3. Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
4. The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).
5. Mandatory provision of an unstained, archived tumour tissue sample in a quantity sufficient to allow for central analysis of EGFR mutation status.
6. Patients must be treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with gefitinib or erlotinib as selected by the participating centre. Prior adjuvant and neo-adjuvant therapy is permitted(chemotherapy, radiotherapy, investigational agents).
7. Provision of informed consent prior to any study specific procedures, sampling, and analysis.
8. World Health Organization Performance Status of 0 to 1 with no clinically significant deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Treatment with any of the following:

* Prior treatment with any systemic anti-cancer therapy for locally advanced/metastatic NSCLC.
* Prior treatment with an EGFR-TKI.
* Major surgery within 4 weeks of the first dose of study drug.
* Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
* Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4.
* Alternative anti-cancer treatment
* Treatment with an investigational drug within five half-lives of the compound or any of its related material.
2. Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of study drug.
3. Spinal cord compression, symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, have a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids.
4. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
5. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291.
6. Any of the following cardiac criteria:

* Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTcF value.
* Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
* Any patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
7. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
8. Involvement in the planning and/or conduct of the study

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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
3/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
Accrual to date
Final
674
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Chermside
Recruitment hospital [3] 0 0
Research Site - Clayton
Recruitment hospital [4] 0 0
Research Site - Heidelberg
Recruitment hospital [5] 0 0
Research Site - Kogarah
Recruitment hospital [6] 0 0
Research Site - Nedlands
Recruitment hospital [7] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
2217 - Kogarah
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
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
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
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Massachusetts
Country [7] 0 0
United States of America
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Minnesota
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United States of America
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New Hampshire
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United States of America
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North Carolina
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United States of America
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Vermont
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Belgium
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Leuven
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Belgium
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Liège
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Belgium
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Roeselare
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Brazil
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Porto Alegre
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Bulgaria
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Sofia
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Canada
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Alberta
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Canada
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Ontario
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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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Chongqing
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Fuzhou
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China
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Guangzhou
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China
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Hangzhou
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China
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Nanjing
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China
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Nanning
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Shanghai
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China
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Shenyang
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China
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Suzhou
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China
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Wuhan
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China
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Xi'an
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China
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Yangzhou
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China
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Ürümqi
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Czechia
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Ostrava
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France
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Caen
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France
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Creteil
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France
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Lyon Cedex 08
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France
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Nantes
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France
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Toulon Naval
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Villejuif
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Germany
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Bad Berka
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Berlin
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Gauting
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Halle
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Heidelberg
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Karlsruhe
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Lübeck
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Germany
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München
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Villingen-Schwenningen
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Hungary
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Farkasgyepü
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Hungary
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Gyöngyös - Mátraháza
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Miskolc
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Haifa
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Israel
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Kfar-Saba
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Israel
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Petach Tikva
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Israel
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Tel Hashomer
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Italy
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Cremona
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Italy
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Lecce
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Italy
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Lecco
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Italy
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Orbassano
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Italy
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Parma
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Italy
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Roma
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Italy
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Sondrio
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Italy
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Terni
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Japan
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Chuo-ku
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Fukuoka-shi
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Japan
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Hirakata-shi
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Kanazawa-shi
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Kashiwa
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Kobe-shi
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Matsuyama-shi
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Osaka-shi
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Osakasayama-shi
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Sagamihara-shi
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Sakai-shi
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Sendai-shi
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Japan
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Sunto-gun
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Yokohama-shi
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Korea, Republic of
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Cheongju-si
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuantan
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Malaysia
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Kuching
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Philippines
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Cebu
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Philippines
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Manila
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Philippines
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Quezon City
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Poland
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Brzozoów
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Poland
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Otwock
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Poland
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Poznan
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Poland
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Szczecin
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Poland
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Warszawa
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Portugal
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Amadora
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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Vila Nova de Gaia
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Craiova
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Russian Federation
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Saint Petersburg
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Spain
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Barcelona
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Spain
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Coruña
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Lugo
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Lérida
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Madrid
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Málaga
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Spain
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Sevilla
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Spain
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Zaragoza
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Sweden
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Linköping
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Switzerland
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Luzern
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Switzerland
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Winterthur
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Switzerland
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Zürich
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Taiwan
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Kaohsiung
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Taiwan
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Taichung City
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Taiwan
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Tainan City
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Taiwan
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Tainan
Country [121] 0 0
Taiwan
State/province [121] 0 0
Taoyuan City
Country [122] 0 0
Thailand
State/province [122] 0 0
Bangkok
Country [123] 0 0
Thailand
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Hat Yai
Country [124] 0 0
Thailand
State/province [124] 0 0
Muang
Country [125] 0 0
Turkey
State/province [125] 0 0
Ankara
Country [126] 0 0
Turkey
State/province [126] 0 0
Istanbul
Country [127] 0 0
Turkey
State/province [127] 0 0
Izmir
Country [128] 0 0
Ukraine
State/province [128] 0 0
Dnipro
Country [129] 0 0
Ukraine
State/province [129] 0 0
Kryvyi Rih
Country [130] 0 0
Ukraine
State/province [130] 0 0
Lviv
Country [131] 0 0
Ukraine
State/province [131] 0 0
Sumy
Country [132] 0 0
United Kingdom
State/province [132] 0 0
London
Country [133] 0 0
United Kingdom
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Maidstone
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United Kingdom
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Withington
Country [135] 0 0
Vietnam
State/province [135] 0 0
Hanoi
Country [136] 0 0
Vietnam
State/province [136] 0 0
Ho Chi Minh City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Parexel
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
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 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)
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.
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 . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02296125