Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02511106
Registration number
NCT02511106
Ethics application status
Date submitted
28/07/2015
Date registered
29/07/2015
Date last updated
27/07/2023
Titles & IDs
Public title
AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.
Query!
Scientific title
A Phase III, Double-blind, Randomized, Placebo-controlled Multi-centre, Study to Assess the Efficacy and Safety of AZD9291 Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy (ADAURA).
Query!
Secondary ID [1]
0
0
2015-000662-65
Query!
Secondary ID [2]
0
0
D5164C00001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ADAURA
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Stage IB-IIIA Non-small Cell Lung Carcinoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Non melanoma skin cancer
Query!
Cancer
0
0
0
0
Query!
Kidney
Query!
Cancer
0
0
0
0
Query!
Lung - Mesothelioma
Query!
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Cancer
0
0
0
0
Query!
Lung - Small cell
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - AZD9291 80 mg/40 mg
Treatment: Drugs - Placebo AZD9291 80 mg/40 mg
Treatment: Drugs - Open-label AZD9291 80 mg/40 mg
Experimental: AZD9291 - AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.
Placebo Comparator: Placebo AZD9291 - Matching placebo for AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.
Treatment: Drugs: AZD9291 80 mg/40 mg
The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily.
Treatment: Drugs: Placebo AZD9291 80 mg/40 mg
The initial dose of Placebo AZD9291 80 mg once daily can be reduced to 40 mg once daily.
Treatment: Drugs: Open-label AZD9291 80 mg/40 mg
Eligible patients will be offered open-label osimertinib upon recurrence and in the absence of intervening systemic anti-cancer therapy.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).
Query!
Assessment method [1]
0
0
Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence)
Query!
Timepoint [1]
0
0
From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years.
Query!
Secondary outcome [1]
0
0
Disease Free Survival (DFS) Rate at 2, 3 and 5 Years
Query!
Assessment method [1]
0
0
Defined as the percentage of patients alive and disease free at 2, 3 and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS at the time of the primary analysis
Query!
Timepoint [1]
0
0
From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years. Assessed at 2 years and 3 years.
Query!
Secondary outcome [2]
0
0
Overall Survival (OS)
Query!
Assessment method [2]
0
0
Defined as the time from the date of randomization until date of death due to any cause.
Query!
Timepoint [2]
0
0
From date of randomization until date of death due to any cause, up to approximately 4 years.
Query!
Secondary outcome [3]
0
0
Overall Survival (OS)
Query!
Assessment method [3]
0
0
Defined as the time from the date of randomization until date of death due to any cause
Query!
Timepoint [3]
0
0
From date of randomization until date of death due to any cause, up to approximately 4 years.
Query!
Secondary outcome [4]
0
0
Overall Survival Rate at 2, 3 and 5 Years
Query!
Assessment method [4]
0
0
Defined as the percentage of patients alive at 2, 3 and 5 years, respectively, estimated from a Kaplan Meier plot of OS at the time of the primary analysis
Query!
Timepoint [4]
0
0
From date of randomization until date of death due to any cause, up to approximately 4 years. Assessed at 2 years and 3 years.
Query!
Secondary outcome [5]
0
0
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Query!
Assessment method [5]
0
0
Change from baseline will be calculated for each domain and summary scale at each scheduled post-baseline assessment. The SF-36 includes eight domains: Physical Functioning (PF); Role Limitations-Physical (RP), Vitality (VT), General Health Perceptions (GH), Bodily Pain (BP), Social Function (SF), Role Limitations-Emotional (RE), and Mental Health (MH) and two summary scores: The Physical Component Summary (PCS) and Mental Component Summary (MCS). Final scores for each scale range from 0-100 with higher scores indicating better health.
Query!
Timepoint [5]
0
0
Measured by SF-36 Questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to approximately 3 years.
Query!
Secondary outcome [6]
0
0
Plasma Concentrations of AZD9291
Query!
Assessment method [6]
0
0
The pharmacokinetics exposure parameters derived from plasma concentrations of AZD9291
Query!
Timepoint [6]
0
0
Collected at pre-dose, 0.5-1.5hours and 2-4hours post-dose up to 96 weeks (approximately 24 months)
Query!
Secondary outcome [7]
0
0
Plasma Concentrations of AZ5104 Metabolites
Query!
Assessment method [7]
0
0
The pharmacokinetics exposure parameters derived from plasma concentrations of AZ5104 metabolites
Query!
Timepoint [7]
0
0
From date of dosing to week 96 (approximately 24 months)
Query!
Secondary outcome [8]
0
0
Plasma Concentrations of AZ7550 Metabolites
Query!
Assessment method [8]
0
0
The pharmacokinetics exposure parameters derived from plasma concentrations of AZ7550 metabolites
Query!
Timepoint [8]
0
0
From date of dosing to week 96 (approximately 24 months)
Query!
Eligibility
Key inclusion criteria
1. Male or female, aged at least 18 years.
2. Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on
predominantly non-squamous histology
3. MRI or CT scan of the brain must be done prior to surgery as it is considered standard
of care.
4. Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of
pathologic criteria.
5. Confirmation by the central laboratory that the tumour harbours one of the 2 common
EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R),
either alone or in combination with other EGFR mutations including T790M.
6. Complete surgical resection of the primary NSCLC is mandatory. All gross disease must
have been removed at the end of surgery. All surgical margins of resection must be
negative for tumour.
7. Complete recovery from surgery and standard post-operative therapy (if applicable) at
the time of randomization.
8. World Health Organization Performance Status of 0 to 1.
9. Female patients should be using adequate contraceptive measures, should not be breast
feeding, and must have a negative pregnancy test prior to first dose of study drug; or
female patients must have an evidence of non-child-bearing potential.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
130
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Treatment with any of the following:
- Pre-operative or post-operative or planned radiation therapy for the current lung
cancer
- Pre-operative (neo-adjuvant) platinum based or other chemotherapy
- Any prior anticancer therapy
- Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time
- Major surgery (including primary tumour surgery, excluding placement of vascular
access) 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
- Treatment with an investigational drug within five half-lives of the compound or
any of its related material.
2. Patients who have had only segmentectomies or wedge resections
3. History of other malignancies, except: adequately treated non-melanoma skin cancer,
curatively treated in-situ cancer, or other solid tumours curatively treated with no
evidence of disease for > 5 years following the end of treatment.
4. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of
starting study treatment with the exception of alopecia and Grade 2, prior
platinum-therapy related neuropathy.
5. 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).
6. 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.
7. 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 QTc value.
- Any clinically important abnormalities in rhythm, conduction, or morphology of
resting ECG.
- 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.
8. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required
steroid treatment, or any evidence of clinically active ILD.
9. Inadequate bone marrow reserve or organ function.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
21/10/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/12/2030
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
682
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Research Site - Bedford Park
Query!
Recruitment hospital [2]
0
0
Research Site - Camperdown
Query!
Recruitment hospital [3]
0
0
Research Site - Darlinghurst
Query!
Recruitment hospital [4]
0
0
Research Site - Heidelberg
Query!
Recruitment hospital [5]
0
0
Research Site - Kogarah
Query!
Recruitment hospital [6]
0
0
Research Site - Kurralta Park
Query!
Recruitment hospital [7]
0
0
Research Site - Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [2]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [3]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [4]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [5]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [6]
0
0
5037 - Kurralta Park
Query!
Recruitment postcode(s) [7]
0
0
4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Hawaii
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Maryland
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New Jersey
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New York
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Rhode Island
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Tennessee
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Virginia
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Brussels
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Brussel
Query!
Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
Gent
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Kortrijk
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
Barretos
Query!
Country [20]
0
0
Brazil
Query!
State/province [20]
0
0
Cachoeira De Itapemirim
Query!
Country [21]
0
0
Brazil
Query!
State/province [21]
0
0
Curitiba
Query!
Country [22]
0
0
Brazil
Query!
State/province [22]
0
0
Florianópolis
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
Fortaleza
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
Lajeado
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
Porto Alegre
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Rio de Janeiro
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Salvador
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
São José do Rio Preto
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
São Paulo
Query!
Country [30]
0
0
Canada
Query!
State/province [30]
0
0
Ontario
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Beijing
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Changchun
Query!
Country [33]
0
0
China
Query!
State/province [33]
0
0
Dalian
Query!
Country [34]
0
0
China
Query!
State/province [34]
0
0
Guangzhou
Query!
Country [35]
0
0
China
Query!
State/province [35]
0
0
Hangzhou
Query!
Country [36]
0
0
China
Query!
State/province [36]
0
0
Kunming
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Nanjing
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Nanning
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Shanghai
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Shenyang
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Suzhou
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Tianjin
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Urumqi
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Xi'an
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
Xiamen
Query!
Country [46]
0
0
China
Query!
State/province [46]
0
0
Yangzhou
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Zhengzhou
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Ürümqi
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Bron
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Lille
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Limoges Cedex
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Lyon
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Paris
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Aachen
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Berlin
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Coswig
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
Gauting
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Gerlingen
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Großhansdorf
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Halle
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Hamburg
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Homburg
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Immenhausen
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Kassel
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Köln
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Lübeck
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Würzburg
Query!
Country [68]
0
0
Hong Kong
Query!
State/province [68]
0
0
Hong Kong
Query!
Country [69]
0
0
Hong Kong
Query!
State/province [69]
0
0
King's Park
Query!
Country [70]
0
0
Hungary
Query!
State/province [70]
0
0
Budapest
Query!
Country [71]
0
0
Hungary
Query!
State/province [71]
0
0
Deszk
Query!
Country [72]
0
0
Hungary
Query!
State/province [72]
0
0
Székesfehérvár
Query!
Country [73]
0
0
Hungary
Query!
State/province [73]
0
0
Törökbálint
Query!
Country [74]
0
0
Israel
Query!
State/province [74]
0
0
Beer-Sheva
Query!
Country [75]
0
0
Israel
Query!
State/province [75]
0
0
Haifa
Query!
Country [76]
0
0
Israel
Query!
State/province [76]
0
0
Jerusalem
Query!
Country [77]
0
0
Israel
Query!
State/province [77]
0
0
Kfar-Saba
Query!
Country [78]
0
0
Israel
Query!
State/province [78]
0
0
Petah Tikva
Query!
Country [79]
0
0
Israel
Query!
State/province [79]
0
0
Ramat Gan
Query!
Country [80]
0
0
Israel
Query!
State/province [80]
0
0
Tel Aviv
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Bari
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
Bergamo
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Bologna
Query!
Country [84]
0
0
Italy
Query!
State/province [84]
0
0
Cremona
Query!
Country [85]
0
0
Italy
Query!
State/province [85]
0
0
Firenze
Query!
Country [86]
0
0
Italy
Query!
State/province [86]
0
0
Lucca
Query!
Country [87]
0
0
Italy
Query!
State/province [87]
0
0
Meldola
Query!
Country [88]
0
0
Italy
Query!
State/province [88]
0
0
Milano
Query!
Country [89]
0
0
Italy
Query!
State/province [89]
0
0
Novara
Query!
Country [90]
0
0
Italy
Query!
State/province [90]
0
0
Orbassano
Query!
Country [91]
0
0
Italy
Query!
State/province [91]
0
0
Padova
Query!
Country [92]
0
0
Italy
Query!
State/province [92]
0
0
Parma
Query!
Country [93]
0
0
Italy
Query!
State/province [93]
0
0
Roma
Query!
Country [94]
0
0
Japan
Query!
State/province [94]
0
0
Bunkyo-ku
Query!
Country [95]
0
0
Japan
Query!
State/province [95]
0
0
Fukuoka
Query!
Country [96]
0
0
Japan
Query!
State/province [96]
0
0
Hirakata-shi
Query!
Country [97]
0
0
Japan
Query!
State/province [97]
0
0
Hiroshima-shi
Query!
Country [98]
0
0
Japan
Query!
State/province [98]
0
0
Kanazawa
Query!
Country [99]
0
0
Japan
Query!
State/province [99]
0
0
Kashiwa
Query!
Country [100]
0
0
Japan
Query!
State/province [100]
0
0
Kitakyushu-shi
Query!
Country [101]
0
0
Japan
Query!
State/province [101]
0
0
Kobe-shi
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Kurume-shi
Query!
Country [103]
0
0
Japan
Query!
State/province [103]
0
0
Matsuyama-shi
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Nagoya-shi
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Niigata-shi
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Osakasayama-shi
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Sagamihara-shi
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Sakai-shi
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Sasebo-shi
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Sendai-shi
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Shinjuku-ku
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Sunto-gun
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Ube-shi
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Yokohama-shi
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Yonago-shi
Query!
Country [116]
0
0
Korea, Republic of
Query!
State/province [116]
0
0
Cheongju-si
Query!
Country [117]
0
0
Korea, Republic of
Query!
State/province [117]
0
0
Seoul
Query!
Country [118]
0
0
Korea, Republic of
Query!
State/province [118]
0
0
Suwon
Query!
Country [119]
0
0
Netherlands
Query!
State/province [119]
0
0
Amsterdam
Query!
Country [120]
0
0
Netherlands
Query!
State/province [120]
0
0
Arnhem
Query!
Country [121]
0
0
Netherlands
Query!
State/province [121]
0
0
Hoofddorp
Query!
Country [122]
0
0
Netherlands
Query!
State/province [122]
0
0
Zwolle
Query!
Country [123]
0
0
Poland
Query!
State/province [123]
0
0
Kraków
Query!
Country [124]
0
0
Poland
Query!
State/province [124]
0
0
Otwock
Query!
Country [125]
0
0
Poland
Query!
State/province [125]
0
0
Poznan
Query!
Country [126]
0
0
Poland
Query!
State/province [126]
0
0
Racibórz
Query!
Country [127]
0
0
Poland
Query!
State/province [127]
0
0
Warszawa
Query!
Country [128]
0
0
Poland
Query!
State/province [128]
0
0
Wieliszew
Query!
Country [129]
0
0
Poland
Query!
State/province [129]
0
0
Lódz
Query!
Country [130]
0
0
Romania
Query!
State/province [130]
0
0
Bucharest
Query!
Country [131]
0
0
Romania
Query!
State/province [131]
0
0
Bucuresti
Query!
Country [132]
0
0
Romania
Query!
State/province [132]
0
0
Cluj Napoca
Query!
Country [133]
0
0
Romania
Query!
State/province [133]
0
0
Craiova
Query!
Country [134]
0
0
Romania
Query!
State/province [134]
0
0
Focsani
Query!
Country [135]
0
0
Romania
Query!
State/province [135]
0
0
Iasi
Query!
Country [136]
0
0
Romania
Query!
State/province [136]
0
0
Timisoara
Query!
Country [137]
0
0
Russian Federation
Query!
State/province [137]
0
0
Arkhangelsk
Query!
Country [138]
0
0
Russian Federation
Query!
State/province [138]
0
0
Kazan
Query!
Country [139]
0
0
Russian Federation
Query!
State/province [139]
0
0
Moscow
Query!
Country [140]
0
0
Russian Federation
Query!
State/province [140]
0
0
Obninsk
Query!
Country [141]
0
0
Russian Federation
Query!
State/province [141]
0
0
Omsk
Query!
Country [142]
0
0
Russian Federation
Query!
State/province [142]
0
0
Pyatigorsk
Query!
Country [143]
0
0
Russian Federation
Query!
State/province [143]
0
0
Rostov-on-Don
Query!
Country [144]
0
0
Russian Federation
Query!
State/province [144]
0
0
Ryazan
Query!
Country [145]
0
0
Russian Federation
Query!
State/province [145]
0
0
Saint Petersburg
Query!
Country [146]
0
0
Russian Federation
Query!
State/province [146]
0
0
Saint-Petersburg
Query!
Country [147]
0
0
Russian Federation
Query!
State/province [147]
0
0
Sankt-Peterburg
Query!
Country [148]
0
0
Russian Federation
Query!
State/province [148]
0
0
St. Petersburg
Query!
Country [149]
0
0
Spain
Query!
State/province [149]
0
0
A Coruña
Query!
Country [150]
0
0
Spain
Query!
State/province [150]
0
0
Barcelona
Query!
Country [151]
0
0
Spain
Query!
State/province [151]
0
0
Elche
Query!
Country [152]
0
0
Spain
Query!
State/province [152]
0
0
Las Palmas de Gran Canaria
Query!
Country [153]
0
0
Spain
Query!
State/province [153]
0
0
Madrid
Query!
Country [154]
0
0
Spain
Query!
State/province [154]
0
0
Majadahonda
Query!
Country [155]
0
0
Spain
Query!
State/province [155]
0
0
Málaga
Query!
Country [156]
0
0
Spain
Query!
State/province [156]
0
0
San Sebastian
Query!
Country [157]
0
0
Spain
Query!
State/province [157]
0
0
Valencia
Query!
Country [158]
0
0
Spain
Query!
State/province [158]
0
0
Zaragoza
Query!
Country [159]
0
0
Sweden
Query!
State/province [159]
0
0
Linköping
Query!
Country [160]
0
0
Taiwan
Query!
State/province [160]
0
0
Changhua
Query!
Country [161]
0
0
Taiwan
Query!
State/province [161]
0
0
Putzu City
Query!
Country [162]
0
0
Taiwan
Query!
State/province [162]
0
0
Taichung City
Query!
Country [163]
0
0
Taiwan
Query!
State/province [163]
0
0
Taichung
Query!
Country [164]
0
0
Taiwan
Query!
State/province [164]
0
0
Tainan City
Query!
Country [165]
0
0
Taiwan
Query!
State/province [165]
0
0
Tainan
Query!
Country [166]
0
0
Taiwan
Query!
State/province [166]
0
0
Taipei
Query!
Country [167]
0
0
Taiwan
Query!
State/province [167]
0
0
Tao-Yuan
Query!
Country [168]
0
0
Thailand
Query!
State/province [168]
0
0
Bangkok
Query!
Country [169]
0
0
Thailand
Query!
State/province [169]
0
0
Chiang Rai
Query!
Country [170]
0
0
Thailand
Query!
State/province [170]
0
0
Khon Kaen
Query!
Country [171]
0
0
Thailand
Query!
State/province [171]
0
0
Mueang
Query!
Country [172]
0
0
Thailand
Query!
State/province [172]
0
0
Phitsanulok
Query!
Country [173]
0
0
Thailand
Query!
State/province [173]
0
0
Songkla
Query!
Country [174]
0
0
Turkey
Query!
State/province [174]
0
0
Ankara
Query!
Country [175]
0
0
Turkey
Query!
State/province [175]
0
0
Bursa
Query!
Country [176]
0
0
Turkey
Query!
State/province [176]
0
0
Istanbul
Query!
Country [177]
0
0
Turkey
Query!
State/province [177]
0
0
Izmir
Query!
Country [178]
0
0
Ukraine
Query!
State/province [178]
0
0
Dnipro
Query!
Country [179]
0
0
Ukraine
Query!
State/province [179]
0
0
Lviv
Query!
Country [180]
0
0
Ukraine
Query!
State/province [180]
0
0
Sumy
Query!
Country [181]
0
0
Ukraine
Query!
State/province [181]
0
0
Uzhhorod
Query!
Country [182]
0
0
Ukraine
Query!
State/province [182]
0
0
Vinnytsia
Query!
Country [183]
0
0
Ukraine
Query!
State/province [183]
0
0
Zaporizhzhia
Query!
Country [184]
0
0
Vietnam
Query!
State/province [184]
0
0
Hanoi
Query!
Country [185]
0
0
Vietnam
Query!
State/province [185]
0
0
Ho Chi Minh
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
AstraZeneca
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal
Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma,
following complete tumour resection with or without adjuvant chemotherapy
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02511106
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02511106
Download to PDF