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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
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Scientific title
First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy
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Secondary ID [1]
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0
D4194R00005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
NSCLC
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0
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Condition category
Condition code
Cancer
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0
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0
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Lung - Non small cell
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating progression free survival (PFS)
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Assessment method [1]
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PFS defined as time from the index date (date of the first dose of durvalumab) to the date of investigator-determined disease progression or death (if no progression) or the end of follow-up
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Timepoint [1]
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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.
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Primary outcome [2]
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To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating overall survival (OS)
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Assessment method [2]
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OS following durvalumab regimen received from the index date to death or end of follow-up.
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Timepoint [2]
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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.
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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.
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
-Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP).
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/12/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
7/06/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
1156
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Ballarat
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Research Site - Bankstown
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Recruitment postcode(s) [1]
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3350 - Ballarat
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2200 - Bankstown
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5042 - Bedford Park
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3550 - Bendigo
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3165 - Bentleigh East
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2576 - Bowral
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3128 - Box Hill
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2560 - Campbelltown
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2050 - Camperdown
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2605 - Canberra
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3168 - Clayton
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2450 - Coffs Harbour
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4814 - Douglas
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5112 - Elizabeth Vale
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3199 - Frankston
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2259 - Hamlyn Terrace
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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
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4700 - Rockhampton
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2065 - St Leonards
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6008 - Subiaco
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3844 - Traralgon
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4224 - Tugun
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3280 - Warrnambool
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3355 - Wendouree
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2145 - Westmead
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2500 - Wollongong
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Recruitment outside Australia
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Belgium
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Aalst
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Ashkelon
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Israel
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Israel
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Haifa
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Israel
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Holon
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Israel
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Jerusalem
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Israel
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Kfar-Saba
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Israel
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Nahariya
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Israel
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Nazareth
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Alessandria
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Arezzo
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Aviano
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Bari
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Catanzaro
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Feltre
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Genova
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Imola
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l'Aquila (AQ)
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Messina
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Mirano
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Modena
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Monza
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Padova
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Parma
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Pavia
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Roma
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Sora
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Terni
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Varese
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Verona
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Arnhem
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Breda
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Den Haag
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Ede
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Eindhoven
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Groningen
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Heerlen
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Zutphen
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Arendal
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Geneva
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Lausanne
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Neuchatel
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Birmingham
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Cardiff
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Colchester
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London
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Manchester
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Poole
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United Kingdom
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Stoke on Trent
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a non-interventional/observational cohort of NSCLC unresectable stage III patients treated with durvalumab. The study will be carried out as a retrospective review of established medical records for a subset of unresectable stage III patients treated with durvalumab.
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Trial website
https://clinicaltrials.gov/study/NCT03798535
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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.
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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.
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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.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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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