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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03798535




Registration number
NCT03798535
Ethics application status
Date submitted
21/12/2018
Date registered
10/01/2019

Titles & IDs
Public title
First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy
Scientific title
First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy
Secondary ID [1] 0 0
D4194R00005
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating progression free survival (PFS)
Timepoint [1] 0 0
PFS is assessed as PFS rates at 12 months and 18 months, and as PFS median for a period of time of 5 years. From Index date (first dose of durvalumab) to progression or death whichever came first, assessed up to 5 years.
Primary outcome [2] 0 0
To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating overall survival (OS)
Timepoint [2] 0 0
OS is assessed as OS rates at 2, 3 and 5 years, and as OS median for a period of time of 5 years. From Index date (first dose of durvalumab) to death or end of follow up, whichever came first, assessed during 5 years.

Eligibility
Key inclusion criteria
* Written informed consent or any locally required authorisation obtained from the patient prior to performing any protocol-related procedures
* Age = 18 years at time of study entry or adult according to each country regulations for age of majority
* Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent, unresectable (stage III) disease (according to American Joint Committee on Cancer [AJCC] lung cancer edition 7 or 8)
* Patients must have been enrolled in one of the durvalumab EAPs Patients must have been treated with at least one dose of durvalumab within the EAP prior to the study entry and between start of EAP in the country, from September 2017 or later up to end of EAP enrolment or MA + three months (estimated as maximum to 30 December 2018) (whichever occurs earlier).

Patients who die during the EAP are eligible to enter in the study when local laws allow for a consent waiver, if all other inclusion/exclusion criteria are met.
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP).

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/07/2024
Sample size
Target
Accrual to date
Final
1156
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Ballarat
Recruitment hospital [2] 0 0
Research Site - Bankstown
Recruitment hospital [3] 0 0
Research Site - Bedford Park
Recruitment hospital [4] 0 0
Research Site - Bendigo
Recruitment hospital [5] 0 0
Research Site - Bentleigh East
Recruitment hospital [6] 0 0
Research Site - Bowral
Recruitment hospital [7] 0 0
Research Site - Box Hill
Recruitment hospital [8] 0 0
Research Site - Campbelltown
Recruitment hospital [9] 0 0
Research Site - Camperdown
Recruitment hospital [10] 0 0
Research Site - Canberra
Recruitment hospital [11] 0 0
Research Site - Clayton
Recruitment hospital [12] 0 0
Research Site - Coffs Harbour
Recruitment hospital [13] 0 0
Research Site - Douglas
Recruitment hospital [14] 0 0
Research Site - Elizabeth Vale
Recruitment hospital [15] 0 0
Research Site - Frankston
Recruitment hospital [16] 0 0
Research Site - Hamlyn Terrace
Recruitment hospital [17] 0 0
Research Site - Hervey Bay
Recruitment hospital [18] 0 0
Research Site - Hobart
Recruitment hospital [19] 0 0
Research Site - Joondalup
Recruitment hospital [20] 0 0
Research Site - Kingswood
Recruitment hospital [21] 0 0
Research Site - Liverpool
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Research Site - Malvern
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Research Site - Melbourne
Recruitment hospital [24] 0 0
Research Site - Murdoch
Recruitment hospital [25] 0 0
Research Site - Orange
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Research Site - Rockhampton
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Research Site - St Leonards
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Research Site - Subiaco
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Research Site - Traralgon
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Research Site - Tugun
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Research Site - Warrnambool
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Research Site - Wendouree
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Research Site - Westmead
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Research Site - Wollongong
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3350 - Ballarat
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2200 - Bankstown
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3550 - Bendigo
Recruitment postcode(s) [5] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [6] 0 0
2576 - Bowral
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
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2560 - Campbelltown
Recruitment postcode(s) [9] 0 0
2050 - Camperdown
Recruitment postcode(s) [10] 0 0
2605 - Canberra
Recruitment postcode(s) [11] 0 0
3168 - Clayton
Recruitment postcode(s) [12] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [13] 0 0
4814 - Douglas
Recruitment postcode(s) [14] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [15] 0 0
3199 - Frankston
Recruitment postcode(s) [16] 0 0
2259 - Hamlyn Terrace
Recruitment postcode(s) [17] 0 0
4655 - Hervey Bay
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7000 - Hobart
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6027 - Joondalup
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2747 - Kingswood
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2170 - Liverpool
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3144 - Malvern
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3000 - Melbourne
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3004 - Melbourne
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6150 - Murdoch
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2800 - Orange
Recruitment postcode(s) [27] 0 0
4700 - Rockhampton
Recruitment postcode(s) [28] 0 0
2065 - St Leonards
Recruitment postcode(s) [29] 0 0
6008 - Subiaco
Recruitment postcode(s) [30] 0 0
3844 - Traralgon
Recruitment postcode(s) [31] 0 0
4224 - Tugun
Recruitment postcode(s) [32] 0 0
3280 - Warrnambool
Recruitment postcode(s) [33] 0 0
3355 - Wendouree
Recruitment postcode(s) [34] 0 0
2145 - Westmead
Recruitment postcode(s) [35] 0 0
2500 - Wollongong
Recruitment outside Australia
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Belgium
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Kuringen
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Liege
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Loverval
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Mons
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Ottignies
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Roeselare
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Ronse
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Yvoir
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Stoke on Trent

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
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Address 0 0
Country 0 0
Phone 0 0
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Email 0 0
Contact person for public queries
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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.
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?

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/NCT03798535