Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03798535




Registration number
NCT03798535
Ethics application status
Date submitted
21/12/2018
Date registered
10/01/2019
Date last updated
29/04/2024

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
Active, not recruiting
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
7/06/2024
Actual
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
Recruitment hospital [22] 0 0
Research Site - Malvern
Recruitment hospital [23] 0 0
Research Site - Melbourne
Recruitment hospital [24] 0 0
Research Site - Murdoch
Recruitment hospital [25] 0 0
Research Site - Orange
Recruitment hospital [26] 0 0
Research Site - Rockhampton
Recruitment hospital [27] 0 0
Research Site - St Leonards
Recruitment hospital [28] 0 0
Research Site - Subiaco
Recruitment hospital [29] 0 0
Research Site - Traralgon
Recruitment hospital [30] 0 0
Research Site - Tugun
Recruitment hospital [31] 0 0
Research Site - Warrnambool
Recruitment hospital [32] 0 0
Research Site - Wendouree
Recruitment hospital [33] 0 0
Research Site - Westmead
Recruitment hospital [34] 0 0
Research Site - Wollongong
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
3165 - Bentleigh East
Recruitment postcode(s) [6] 0 0
2576 - Bowral
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
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
Recruitment postcode(s) [18] 0 0
7000 - Hobart
Recruitment postcode(s) [19] 0 0
6027 - Joondalup
Recruitment postcode(s) [20] 0 0
2747 - Kingswood
Recruitment postcode(s) [21] 0 0
2170 - Liverpool
Recruitment postcode(s) [22] 0 0
3144 - Malvern
Recruitment postcode(s) [23] 0 0
3000 - Melbourne
Recruitment postcode(s) [24] 0 0
3004 - Melbourne
Recruitment postcode(s) [25] 0 0
6150 - Murdoch
Recruitment postcode(s) [26] 0 0
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
Country [1] 0 0
Belgium
State/province [1] 0 0
Aalst
Country [2] 0 0
Belgium
State/province [2] 0 0
Bouge
Country [3] 0 0
Belgium
State/province [3] 0 0
Braine-l'Alleud
Country [4] 0 0
Belgium
State/province [4] 0 0
Brasschaat
Country [5] 0 0
Belgium
State/province [5] 0 0
Brussels
Country [6] 0 0
Belgium
State/province [6] 0 0
Bruxelles
Country [7] 0 0
Belgium
State/province [7] 0 0
Dendermonde
Country [8] 0 0
Belgium
State/province [8] 0 0
Gent
Country [9] 0 0
Belgium
State/province [9] 0 0
Hasselt
Country [10] 0 0
Belgium
State/province [10] 0 0
Herstal
Country [11] 0 0
Belgium
State/province [11] 0 0
Heusden-Zolder
Country [12] 0 0
Belgium
State/province [12] 0 0
Ieper
Country [13] 0 0
Belgium
State/province [13] 0 0
Kuringen
Country [14] 0 0
Belgium
State/province [14] 0 0
Liege
Country [15] 0 0
Belgium
State/province [15] 0 0
Loverval
Country [16] 0 0
Belgium
State/province [16] 0 0
Mons
Country [17] 0 0
Belgium
State/province [17] 0 0
Ottignies
Country [18] 0 0
Belgium
State/province [18] 0 0
Roeselare
Country [19] 0 0
Belgium
State/province [19] 0 0
Ronse
Country [20] 0 0
Belgium
State/province [20] 0 0
Sint-Niklaas
Country [21] 0 0
Belgium
State/province [21] 0 0
Sint-Truiden
Country [22] 0 0
Belgium
State/province [22] 0 0
Yvoir
Country [23] 0 0
France
State/province [23] 0 0
Abbeville
Country [24] 0 0
France
State/province [24] 0 0
Aix en Provence
Country [25] 0 0
France
State/province [25] 0 0
Albi Cedex 09
Country [26] 0 0
France
State/province [26] 0 0
Antony
Country [27] 0 0
France
State/province [27] 0 0
Avignon Cedex 09
Country [28] 0 0
France
State/province [28] 0 0
Bayonne
Country [29] 0 0
France
State/province [29] 0 0
Bethune Cedex
Country [30] 0 0
France
State/province [30] 0 0
Beziers
Country [31] 0 0
France
State/province [31] 0 0
Bobigny cedex
Country [32] 0 0
France
State/province [32] 0 0
Bordeaux
Country [33] 0 0
France
State/province [33] 0 0
Boulogne Billancourt Cedex
Country [34] 0 0
France
State/province [34] 0 0
Brest Cedex
Country [35] 0 0
France
State/province [35] 0 0
Carcassonne Cedex
Country [36] 0 0
France
State/province [36] 0 0
Chauny
Country [37] 0 0
France
State/province [37] 0 0
Clermont-Ferrand
Country [38] 0 0
France
State/province [38] 0 0
Colmar
Country [39] 0 0
France
State/province [39] 0 0
Contamine sur Arve
Country [40] 0 0
France
State/province [40] 0 0
Creteil Cedex
Country [41] 0 0
France
State/province [41] 0 0
Dijon cedex
Country [42] 0 0
France
State/province [42] 0 0
GAP Cedex
Country [43] 0 0
France
State/province [43] 0 0
Grenoble
Country [44] 0 0
France
State/province [44] 0 0
La Roche sur Yon Cedex 9
Country [45] 0 0
France
State/province [45] 0 0
La Rochelle Cedex
Country [46] 0 0
France
State/province [46] 0 0
Le Mans Cedex
Country [47] 0 0
France
State/province [47] 0 0
Levallois-Perret
Country [48] 0 0
France
State/province [48] 0 0
Libourne Cedex
Country [49] 0 0
France
State/province [49] 0 0
Lille
Country [50] 0 0
France
State/province [50] 0 0
Limoges
Country [51] 0 0
France
State/province [51] 0 0
Lorient
Country [52] 0 0
France
State/province [52] 0 0
Lyon Cedex 08
Country [53] 0 0
France
State/province [53] 0 0
Macon
Country [54] 0 0
France
State/province [54] 0 0
MARSEILLE Cedex 20
Country [55] 0 0
France
State/province [55] 0 0
Marseille
Country [56] 0 0
France
State/province [56] 0 0
Metz-Tessy
Country [57] 0 0
France
State/province [57] 0 0
Montpellier
Country [58] 0 0
France
State/province [58] 0 0
Morlaix Cedex
Country [59] 0 0
France
State/province [59] 0 0
Muret
Country [60] 0 0
France
State/province [60] 0 0
Nancy
Country [61] 0 0
France
State/province [61] 0 0
Nimes
Country [62] 0 0
France
State/province [62] 0 0
Paris Cedex 10
Country [63] 0 0
France
State/province [63] 0 0
Paris Cedex 14
Country [64] 0 0
France
State/province [64] 0 0
Paris Cedex 5
Country [65] 0 0
France
State/province [65] 0 0
Paris
Country [66] 0 0
France
State/province [66] 0 0
Pau cedex
Country [67] 0 0
France
State/province [67] 0 0
Perigueux
Country [68] 0 0
France
State/province [68] 0 0
Perpignan
Country [69] 0 0
France
State/province [69] 0 0
Pierre Benite Cedex
Country [70] 0 0
France
State/province [70] 0 0
Poitiers
Country [71] 0 0
France
State/province [71] 0 0
Rennes Cedex 9
Country [72] 0 0
France
State/province [72] 0 0
Rouen Cedex
Country [73] 0 0
France
State/province [73] 0 0
Saint Nazaire Cedex
Country [74] 0 0
France
State/province [74] 0 0
Saint Priest en Jarez
Country [75] 0 0
France
State/province [75] 0 0
Saint-Aubin-les-Elbeuf
Country [76] 0 0
France
State/province [76] 0 0
Saint-Quentin cedex
Country [77] 0 0
France
State/province [77] 0 0
Tarbes
Country [78] 0 0
France
State/province [78] 0 0
Toulon cedex 9
Country [79] 0 0
France
State/province [79] 0 0
Toulouse
Country [80] 0 0
France
State/province [80] 0 0
Tours cedex
Country [81] 0 0
France
State/province [81] 0 0
Valence
Country [82] 0 0
France
State/province [82] 0 0
Vantoux
Country [83] 0 0
France
State/province [83] 0 0
Villefranche-sur-Saone cedex
Country [84] 0 0
Germany
State/province [84] 0 0
Berlin
Country [85] 0 0
Germany
State/province [85] 0 0
Bochum
Country [86] 0 0
Germany
State/province [86] 0 0
Bremen
Country [87] 0 0
Germany
State/province [87] 0 0
Dresden
Country [88] 0 0
Germany
State/province [88] 0 0
Erlangen
Country [89] 0 0
Germany
State/province [89] 0 0
Essen
Country [90] 0 0
Germany
State/province [90] 0 0
Esslingen
Country [91] 0 0
Germany
State/province [91] 0 0
Furth
Country [92] 0 0
Germany
State/province [92] 0 0
Georgsmarienhuette
Country [93] 0 0
Germany
State/province [93] 0 0
Gutersloh
Country [94] 0 0
Germany
State/province [94] 0 0
Halle (Saale)
Country [95] 0 0
Germany
State/province [95] 0 0
Hamburg
Country [96] 0 0
Germany
State/province [96] 0 0
Immenhausen
Country [97] 0 0
Germany
State/province [97] 0 0
Kaiserslautern
Country [98] 0 0
Germany
State/province [98] 0 0
Karlsruhe
Country [99] 0 0
Germany
State/province [99] 0 0
Kempten
Country [100] 0 0
Germany
State/province [100] 0 0
Muenchen
Country [101] 0 0
Germany
State/province [101] 0 0
Munnerstadt
Country [102] 0 0
Germany
State/province [102] 0 0
Oldenburg
Country [103] 0 0
Germany
State/province [103] 0 0
Paderborn
Country [104] 0 0
Germany
State/province [104] 0 0
Recklinghausen
Country [105] 0 0
Germany
State/province [105] 0 0
Regensburg
Country [106] 0 0
Germany
State/province [106] 0 0
Rostock
Country [107] 0 0
Germany
State/province [107] 0 0
Wurselen
Country [108] 0 0
Israel
State/province [108] 0 0
Ashkelon
Country [109] 0 0
Israel
State/province [109] 0 0
Beer Sheva
Country [110] 0 0
Israel
State/province [110] 0 0
Haifa
Country [111] 0 0
Israel
State/province [111] 0 0
Holon
Country [112] 0 0
Israel
State/province [112] 0 0
Jerusalem
Country [113] 0 0
Israel
State/province [113] 0 0
Kfar-Saba
Country [114] 0 0
Israel
State/province [114] 0 0
Nahariya
Country [115] 0 0
Israel
State/province [115] 0 0
Nazareth
Country [116] 0 0
Israel
State/province [116] 0 0
Petah Tikva
Country [117] 0 0
Israel
State/province [117] 0 0
Ramat Gan
Country [118] 0 0
Israel
State/province [118] 0 0
Tel Aviv
Country [119] 0 0
Italy
State/province [119] 0 0
Alessandria
Country [120] 0 0
Italy
State/province [120] 0 0
Ancona
Country [121] 0 0
Italy
State/province [121] 0 0
Arezzo
Country [122] 0 0
Italy
State/province [122] 0 0
Aviano
Country [123] 0 0
Italy
State/province [123] 0 0
Bari
Country [124] 0 0
Italy
State/province [124] 0 0
Bolzano
Country [125] 0 0
Italy
State/province [125] 0 0
Brescia
Country [126] 0 0
Italy
State/province [126] 0 0
Catanzaro
Country [127] 0 0
Italy
State/province [127] 0 0
Feltre
Country [128] 0 0
Italy
State/province [128] 0 0
Firenze
Country [129] 0 0
Italy
State/province [129] 0 0
Genova
Country [130] 0 0
Italy
State/province [130] 0 0
Imola
Country [131] 0 0
Italy
State/province [131] 0 0
l'Aquila (AQ)
Country [132] 0 0
Italy
State/province [132] 0 0
La Spezia
Country [133] 0 0
Italy
State/province [133] 0 0
Lecce
Country [134] 0 0
Italy
State/province [134] 0 0
Lido di Camaiore
Country [135] 0 0
Italy
State/province [135] 0 0
Meldola
Country [136] 0 0
Italy
State/province [136] 0 0
Messina
Country [137] 0 0
Italy
State/province [137] 0 0
Milano
Country [138] 0 0
Italy
State/province [138] 0 0
Mirano
Country [139] 0 0
Italy
State/province [139] 0 0
Modena
Country [140] 0 0
Italy
State/province [140] 0 0
Monza
Country [141] 0 0
Italy
State/province [141] 0 0
Napoli
Country [142] 0 0
Italy
State/province [142] 0 0
Padova
Country [143] 0 0
Italy
State/province [143] 0 0
Parma
Country [144] 0 0
Italy
State/province [144] 0 0
Pavia
Country [145] 0 0
Italy
State/province [145] 0 0
Perugia
Country [146] 0 0
Italy
State/province [146] 0 0
Pisa
Country [147] 0 0
Italy
State/province [147] 0 0
Pistoia
Country [148] 0 0
Italy
State/province [148] 0 0
Ravenna
Country [149] 0 0
Italy
State/province [149] 0 0
Reggio Emilia
Country [150] 0 0
Italy
State/province [150] 0 0
Rimini
Country [151] 0 0
Italy
State/province [151] 0 0
Rionero In Vulture (PZ)
Country [152] 0 0
Italy
State/province [152] 0 0
Roma
Country [153] 0 0
Italy
State/province [153] 0 0
Rozzano
Country [154] 0 0
Italy
State/province [154] 0 0
Sora
Country [155] 0 0
Italy
State/province [155] 0 0
Terni
Country [156] 0 0
Italy
State/province [156] 0 0
Treviglio
Country [157] 0 0
Italy
State/province [157] 0 0
Trieste
Country [158] 0 0
Italy
State/province [158] 0 0
Udine
Country [159] 0 0
Italy
State/province [159] 0 0
Varese
Country [160] 0 0
Italy
State/province [160] 0 0
Verona
Country [161] 0 0
Netherlands
State/province [161] 0 0
Alkmaar
Country [162] 0 0
Netherlands
State/province [162] 0 0
Amersfoort
Country [163] 0 0
Netherlands
State/province [163] 0 0
Amsterdam
Country [164] 0 0
Netherlands
State/province [164] 0 0
Arnhem
Country [165] 0 0
Netherlands
State/province [165] 0 0
Breda
Country [166] 0 0
Netherlands
State/province [166] 0 0
Den Haag
Country [167] 0 0
Netherlands
State/province [167] 0 0
Ede
Country [168] 0 0
Netherlands
State/province [168] 0 0
Eindhoven
Country [169] 0 0
Netherlands
State/province [169] 0 0
Groningen
Country [170] 0 0
Netherlands
State/province [170] 0 0
Heerlen
Country [171] 0 0
Netherlands
State/province [171] 0 0
Hertogenbosch
Country [172] 0 0
Netherlands
State/province [172] 0 0
Hilversum
Country [173] 0 0
Netherlands
State/province [173] 0 0
Leiden
Country [174] 0 0
Netherlands
State/province [174] 0 0
Maastricht
Country [175] 0 0
Netherlands
State/province [175] 0 0
Nieuwegein
Country [176] 0 0
Netherlands
State/province [176] 0 0
Nijmegen
Country [177] 0 0
Netherlands
State/province [177] 0 0
Rotterdam
Country [178] 0 0
Netherlands
State/province [178] 0 0
Utrecht
Country [179] 0 0
Netherlands
State/province [179] 0 0
Zutphen
Country [180] 0 0
Norway
State/province [180] 0 0
Arendal
Country [181] 0 0
Norway
State/province [181] 0 0
Drammen
Country [182] 0 0
Norway
State/province [182] 0 0
Oslo
Country [183] 0 0
Norway
State/province [183] 0 0
Tromso
Country [184] 0 0
Switzerland
State/province [184] 0 0
Altdorf
Country [185] 0 0
Switzerland
State/province [185] 0 0
Bulach
Country [186] 0 0
Switzerland
State/province [186] 0 0
Chur
Country [187] 0 0
Switzerland
State/province [187] 0 0
Fribourg
Country [188] 0 0
Switzerland
State/province [188] 0 0
Geneva
Country [189] 0 0
Switzerland
State/province [189] 0 0
Lausanne
Country [190] 0 0
Switzerland
State/province [190] 0 0
Neuchatel
Country [191] 0 0
United Kingdom
State/province [191] 0 0
Birmingham
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Cardiff
Country [193] 0 0
United Kingdom
State/province [193] 0 0
Colchester
Country [194] 0 0
United Kingdom
State/province [194] 0 0
London
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Manchester
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Nottingham
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Poole
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Stoke on Trent

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/ct2/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03798535