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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03798535
Ethics application status
Date submitted
21/12/2018
Date registered
10/01/2019
Date last updated
12/08/2019

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

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) - 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
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) - OS following durvalumab regimen received from the index date to death or end of follow-up.
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
No limit
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 - Bowral
Recruitment hospital [6] 0 0
Research Site - Box Hill
Recruitment hospital [7] 0 0
Research Site - Campbelltown
Recruitment hospital [8] 0 0
Research Site - Camperdown
Recruitment hospital [9] 0 0
Research Site - Canberra
Recruitment hospital [10] 0 0
Research Site - Douglas
Recruitment hospital [11] 0 0
Research Site - Elizabeth Vale
Recruitment hospital [12] 0 0
Research Site - Epping
Recruitment hospital [13] 0 0
Research Site - Frankston
Recruitment hospital [14] 0 0
Research Site - Hamlyn Terrace
Recruitment hospital [15] 0 0
Research Site - Hobart
Recruitment hospital [16] 0 0
Research Site - Joondalup
Recruitment hospital [17] 0 0
Research Site - Liverpool
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Research Site - Malvern
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Research Site - Melbourne
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Research Site - Midland
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Research Site - Orange
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Research Site - Randwick
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Research Site - Rockhampton
Recruitment hospital [24] 0 0
Research Site - Southport
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Research Site - Spencer Park
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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 - Warrnambool
Recruitment hospital [30] 0 0
Research Site - Wendouree
Recruitment hospital [31] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
3350 - Ballarat
Recruitment postcode(s) [2] 0 0
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
2576 - Bowral
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
2560 - Campbelltown
Recruitment postcode(s) [8] 0 0
2050 - Camperdown
Recruitment postcode(s) [9] 0 0
2605 - Canberra
Recruitment postcode(s) [10] 0 0
QLD 4814 - Douglas
Recruitment postcode(s) [11] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [12] 0 0
3076 - Epping
Recruitment postcode(s) [13] 0 0
3199 - Frankston
Recruitment postcode(s) [14] 0 0
2259 - Hamlyn Terrace
Recruitment postcode(s) [15] 0 0
7000 - Hobart
Recruitment postcode(s) [16] 0 0
6027 - Joondalup
Recruitment postcode(s) [17] 0 0
2170 - Liverpool
Recruitment postcode(s) [18] 0 0
3144 - Malvern
Recruitment postcode(s) [19] 0 0
3000 - Melbourne
Recruitment postcode(s) [20] 0 0
3004 - Melbourne
Recruitment postcode(s) [21] 0 0
6056 - Midland
Recruitment postcode(s) [22] 0 0
2800 - Orange
Recruitment postcode(s) [23] 0 0
2031 - Randwick
Recruitment postcode(s) [24] 0 0
4700 - Rockhampton
Recruitment postcode(s) [25] 0 0
4215 - Southport
Recruitment postcode(s) [26] 0 0
6330 - Spencer Park
Recruitment postcode(s) [27] 0 0
2065 - St Leonards
Recruitment postcode(s) [28] 0 0
6008 - Subiaco
Recruitment postcode(s) [29] 0 0
3844 - Traralgon
Recruitment postcode(s) [30] 0 0
3280 - Warrnambool
Recruitment postcode(s) [31] 0 0
3355 - Wendouree
Recruitment postcode(s) [32] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Belgium
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Bouge
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Brasschaat
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Brussels
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Dendermonde
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Gent
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Hasselt
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Heusden-Zolder
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Ieper
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Kuringen
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Liège
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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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Belgium
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Sint-Niklaas
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Sint-Truiden
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Belgium
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Yvoir
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Abbeville
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Nancy
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Nice Cedex 2
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Nîmes
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Country [208] 0 0
United Kingdom
State/province [208] 0 0
Cardiff
Country [209] 0 0
United Kingdom
State/province [209] 0 0
Colchester
Country [210] 0 0
United Kingdom
State/province [210] 0 0
Exeter
Country [211] 0 0
United Kingdom
State/province [211] 0 0
Ipswich
Country [212] 0 0
United Kingdom
State/province [212] 0 0
Leeds
Country [213] 0 0
United Kingdom
State/province [213] 0 0
London
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Manchester
Country [215] 0 0
United Kingdom
State/province [215] 0 0
Newcastle upon Tyne
Country [216] 0 0
United Kingdom
State/province [216] 0 0
Nottingham
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Portsmouth

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03798535
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
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03798535