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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02511106




Registration number
NCT02511106
Ethics application status
Date submitted
28/07/2015
Date registered
29/07/2015

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.
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).
Secondary ID [1] 0 0
2023-506524-82-00
Secondary ID [2] 0 0
D5164C00001
Universal Trial Number (UTN)
Trial acronym
ADAURA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage IB-IIIA Non-small Cell Lung Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
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
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).
Timepoint [1] 0 0
Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months)
Secondary outcome [1] 0 0
Disease Free Survival (DFS) Rate at 2, 3 and 5 Years
Timepoint [1] 0 0
Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months). DFS rate at 2 years (%), 3 years (%) and 5 years (%) are presented.
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 7 years after the first patient is randomized (maximum follow up of 86 months)
Secondary outcome [3] 0 0
Overall Survival Rate at 2, 3 and 5 Years
Timepoint [3] 0 0
Up to approximately 7 years after the first patient is randomized (maximum follow up of 86 months). OS rate at 2 years (%), 3 years (%) and 5 years (%) are presented.
Secondary outcome [4] 0 0
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Timepoint [4] 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 3 years.
Secondary outcome [5] 0 0
Plasma Concentrations of AZD9291
Timepoint [5] 0 0
Collected at pre-dose, 0.5-1.5hours and 2-4hours post-dose up to 96 weeks (approximately 24 months)
Secondary outcome [6] 0 0
Plasma Concentrations of AZ5104 Metabolites
Timepoint [6] 0 0
From date of dosing to week 96 (approximately 24 months)
Secondary outcome [7] 0 0
Plasma Concentrations of AZ7550 Metabolites
Timepoint [7] 0 0
From date of dosing to week 96 (approximately 24 months)

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.
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
21/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2029
Actual
Sample size
Target
Accrual to date
Final
682
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bedford Park
Recruitment hospital [2] 0 0
Research Site - Camperdown
Recruitment hospital [3] 0 0
Research Site - Darlinghurst
Recruitment hospital [4] 0 0
Research Site - Heidelberg
Recruitment hospital [5] 0 0
Research Site - Kogarah
Recruitment hospital [6] 0 0
Research Site - Kurralta Park
Recruitment hospital [7] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
2217 - Kogarah
Recruitment postcode(s) [6] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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United States of America
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Hawaii
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United States of America
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Illinois
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Maryland
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New York
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Rhode Island
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Valencia
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Sweden
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Tao-Yuan
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Thailand
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Bangkok
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Chiang Rai
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Mueang
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Songkla
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Turkey
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Ankara
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Bursa
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Turkey
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Istanbul
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Turkey
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Izmir
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Ukraine
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Dnipro
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Lviv
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Sumy
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Zaporizhzhia
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Vietnam
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Hanoi
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Vietnam
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Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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 deidentified 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

TypeCitations or Other Details
Journal Herbst RS, Wu YL, Tsuboi M. Osimertinib in EGFR-Mu... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT02511106