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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02474355




Registration number
NCT02474355
Ethics application status
Date submitted
27/05/2015
Date registered
17/06/2015
Date last updated
11/11/2021

Titles & IDs
Public title
Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC
Scientific title
Open Label, Multinational, Multicenter, Real World Treatment Study of Single Agent AZD9291 for Patients With Advanced/Metastatic Epidermal Growth Factor Receptor (EGFR) T790M Mutation-Positive Non-Small Cell Lung Cancer (NSCLC) Who Have Received Prior Therapy With an EGFR Tyrosine Kinase Inhibitor (EGFR-TKI)
Secondary ID [1] 0 0
D5160C00022
Universal Trial Number (UTN)
Trial acronym
ASTRIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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: Surgery - T790M+ Testing
Treatment: Surgery - Baseline Visit Blood & Urine Testing
Treatment: Surgery - Baseline ECG
Treatment: Surgery - Visual Slit-Lamp Testing
Treatment: Drugs - AZD9291 Dosing

Experimental: AZD9291 - Single arm of AZD9291, starting dose of 80mg


Treatment: Surgery: T790M+ Testing
If a previous lab report is unavailable, the patient will need to have T790M+ testing.

Treatment: Surgery: Baseline Visit Blood & Urine Testing
Blood count and standard chemistry testing to ensure patient meets inclusion/exclusion criteria

Treatment: Surgery: Baseline ECG
ECG to ensure absence of any cardiac abnormality

Treatment: Surgery: Visual Slit-Lamp Testing
Slit-lamp testing performed to ensure patients do not have any eye abnormalities or symptoms

Treatment: Drugs: AZD9291 Dosing
Patients to be provided with AZD9291 every 6 weeks (+/- 7 days)
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From the date of first dose of Osimertinib until the date of death (due to any cause) or last participant contact [up to 43 months]
Primary outcome [2] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [2] 0 0
From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Secondary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
From the date of first dose of Osimertinib until disease progression or death in the absence of progression [up to 43 months]
Secondary outcome [2] 0 0
Time to Treatment Discontinuation (TTD)
Timepoint [2] 0 0
From the date of first dose of Osimertinib until disease progression or death in the absence of progression [up to 43 months]
Secondary outcome [3] 0 0
Response Rate (RR)
Timepoint [3] 0 0
From the date of first dose of Osimertinib until disease progression or death in the absence of progression [up to 43 months]

Eligibility
Key inclusion criteria
1. Provision of signed and dated written informed consent by the patient or legally
acceptable representative prior to any study-specific procedures

2. Adults (according to each country regulations for age of majority)

3. Locally advanced (stage IIIB) or metastatic (stage IV) EGFRm NSCLC, not amenable to
curative surgery or radiotherapy, with confirmation of the presence of the T790M
mutation

4. Prior therapy with an EGFR-TKI. Patients may have also received additional lines of
treatment

5. World Health Organization (WHO) performance status 0-2

6. Adequate bone marrow reserve and organ function as demonstrated by complete blood
count, biochemistry in blood and urine at baseline (please refer to IB for guidance)

7. ECG recording at baseline showing absence of any cardiac abnormality as per exclusion
criterion #6

8. Female patients of childbearing potential must be using adequate contraceptive
measures, must not be breast feeding, and must have a negative pregnancy test prior to
start of dosing. Otherwise, they must have evidence of nonchildbearing potential

9. Male patients must be willing to use barrier contraception, i.e., condoms
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous (within 6 months) or current treatment with AZD9291

2. Patients currently receiving (or unable to stop use at least 1 week prior to receiving
the first dose of AZD9291) any treatment known to be potent inhibitors or inducers of
cytochrome P450 (CYP) 3A4

3. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled
hypertension, active bleeding diatheses, active infection including hepatitis B,
hepatitis C, and human immunodeficiency virus, or significantly impaired bone marrow
reserve or organ function, including hepatic and renal impairment, which in the
investigator's opinion would significantly alter the risk/benefit balance.

4. Patient with symptomatic central nervous system (CNS) metastases who is neurologically
unstable or has required increasing doses of steroids to manage CNS symptoms within
the 2 weeks prior to start AZD9291 administration;

5. Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid
treatment, or any evidence of clinically active ILD

6. Any of the following cardiac criteria:

1. Mean resting corrected QT interval (QTcF) > 470 ms using Fredericia's formula :

2. Any clinically important abnormalities in rhythm, conduction or morphology of
resting ECG (e.g., complete left bundle branch block, third degree heart block,
second degree heart block)

3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic
events

7. Any unresolved toxicity from prior therapy CTCAE > grade 3 at the time of starting
treatment

8. History of hypersensitivity to excipients of AZD9291 or to drugs with a similar
chemical structure or class to AZD9291

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/04/2019
Sample size
Target
Accrual to date
Final
3017
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bedford Park
Recruitment hospital [2] 0 0
Research Site - East Melbourne
Recruitment hospital [3] 0 0
Research Site - Kurralta Park
Recruitment hospital [4] 0 0
Research Site - Randwick
Recruitment hospital [5] 0 0
Research Site - Waratah
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
2298 - Waratah
Recruitment outside Australia
Country [1] 0 0
Argentina
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Buenos Aires
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Argentina
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Caba
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Austria
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Innsbruck
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Linz
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Salzburg
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Wien
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Charleroi
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Edegem
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Leuven
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Ijui
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Salvador
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Alberta
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British Columbia
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Ontario
Country [22] 0 0
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Quebec
Country [23] 0 0
Canada
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Regina, Saskatchewan
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Beijing
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Yancheng
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Uppsala
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Antrim
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Poole
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Wolverhampton

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
The aim of this study is to assess the efficacy and safety of single agent AZD9291 in a real
world setting in adult patients with advanced or metastatic, epidermal growth factor receptor
(EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), who have received prior
EGFR-tyrosine kinase inhibitor (TKI) therapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02474355
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
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Phone 0 0
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Email 0 0
Contact person for scientific queries