First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy

NSCLC Clinical Trial

Official title:

First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03798535
• Other study ID #: D4194R00005
• Status: Active, not recruiting
• Start date: December 19, 2018
• Est. completion date: June 7, 2024

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a non-interventional/observational study including NSCLC unresectable Stage III patients treated with durvalumab. Patient selection and retrospective data collection will be from participating countries: Australia, Belgium, Israel, Netherlands, Norway France, Germany, Italy, Switzerland, Spain

Chart abstractions will occur at specified intervals up to five years after the patient had the first dose of durvalumab. A target of four (maximum five) chart extractions is anticipated for each participant. Dates may be adjusted based on local market ethics processes or patient enrolment.

• First chart extraction will be used to determine which patients meet the inclusion/exclusion criteria for the study and will retrospectively collect all data from diagnosis of stage III unresectable NSCLC and the durvalumab start date (index date).

• The second chart extraction will be triggered at time of estimated maturity of PFS data to provide an accurate measure of the PFS outcome.

• The third chart extraction will be triggered at time of estimated maturity of OS data to provide an accurate measure of the OS outcome• The fourth and fifth chart extractions will occur approximately 3-years and 5-years after enrolment

• The dates for the second through fifth chart abstractions may be adjusted, pending data availability. The estimated PFS and OS maturity will be calculated from the actual patient index dates (date of first dose of durvalumab) and any available data on PFS and OS observed in the first extraction together with the distribution of PFS and OS observed in the PACIFIC trial.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1156
• Est. completion date: June 7, 2024
• Est. primary completion date: June 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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.

Exclusion Criteria:

-Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP).

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Locations

Country	Name	City	State
Australia	Research Site	Ballarat
Australia	Research Site	Bankstown
Australia	Research Site	Bedford Park
Australia	Research Site	Bendigo
Australia	Research Site	Bentleigh East
Australia	Research Site	Bowral
Australia	Research Site	Box Hill
Australia	Research Site	Campbelltown
Australia	Research Site	Camperdown
Australia	Research Site	Canberra
Australia	Research Site	Clayton
Australia	Research Site	Coffs Harbour
Australia	Research Site	Douglas
Australia	Research Site	Elizabeth Vale
Australia	Research Site	Frankston
Australia	Research Site	Hamlyn Terrace
Australia	Research Site	Hervey Bay
Australia	Research Site	Hobart
Australia	Research Site	Joondalup
Australia	Research Site	Kingswood
Australia	Research Site	Liverpool
Australia	Research Site	Malvern
Australia	Research Site	Melbourne
Australia	Research Site	Melbourne
Australia	Research Site	Murdoch
Australia	Research Site	Orange
Australia	Research Site	Rockhampton
Australia	Research Site	St Leonards
Australia	Research Site	Subiaco
Australia	Research Site	Traralgon
Australia	Research Site	Tugun
Australia	Research Site	Warrnambool
Australia	Research Site	Wendouree
Australia	Research Site	Westmead
Australia	Research Site	Wollongong
Belgium	Research Site	Aalst
Belgium	Research Site	Bouge
Belgium	Research Site	Braine-l'Alleud
Belgium	Research Site	Brasschaat
Belgium	Research Site	Brussels
Belgium	Research Site	Brussels
Belgium	Research Site	Bruxelles
Belgium	Research Site	Dendermonde
Belgium	Research Site	Gent
Belgium	Research Site	Hasselt
Belgium	Research Site	Herstal
Belgium	Research Site	Heusden-Zolder
Belgium	Research Site	Ieper
Belgium	Research Site	Kuringen
Belgium	Research Site	Liege
Belgium	Research Site	Loverval
Belgium	Research Site	Mons
Belgium	Research Site	Ottignies
Belgium	Research Site	Roeselare
Belgium	Research Site	Ronse
Belgium	Research Site	Sint-Niklaas
Belgium	Research Site	Sint-Truiden
Belgium	Research Site	Yvoir
France	Research Site	Abbeville
France	Research Site	Aix en Provence
France	Research Site	Albi Cedex 09
France	Research Site	Antony
France	Research Site	Avignon Cedex 09
France	Research Site	Bayonne
France	Research Site	Bethune Cedex
France	Research Site	Beziers
France	Research Site	Bobigny cedex
France	Research Site	Bordeaux
France	Research Site	Bordeaux
France	Research Site	Boulogne Billancourt Cedex
France	Research Site	Brest Cedex
France	Research Site	Carcassonne Cedex
France	Research Site	Chauny
France	Research Site	Clermont-Ferrand
France	Research Site	Colmar
France	Research Site	Contamine sur Arve
France	Research Site	Creteil Cedex
France	Research Site	Dijon cedex
France	Research Site	Dijon cedex
France	Research Site	GAP Cedex
France	Research Site	Grenoble
France	Research Site	La Roche sur Yon Cedex 9
France	Research Site	La Rochelle Cedex
France	Research Site	Le Mans Cedex
France	Research Site	Levallois-Perret
France	Research Site	Libourne Cedex
France	Research Site	Lille
France	Research Site	Limoges
France	Research Site	Lorient
France	Research Site	Lyon Cedex 08
France	Research Site	Macon
France	Research Site	Marseille
France	Research Site	MARSEILLE Cedex 20
France	Research Site	Metz-Tessy
France	Research Site	Montpellier
France	Research Site	Montpellier
France	Research Site	Morlaix Cedex
France	Research Site	Muret
France	Research Site	Nancy
France	Research Site	Nimes
France	Research Site	Paris
France	Research Site	Paris
France	Research Site	Paris Cedex 10
France	Research Site	Paris Cedex 14
France	Research Site	Paris Cedex 5
France	Research Site	Pau cedex
France	Research Site	Perigueux
France	Research Site	Perpignan
France	Research Site	Pierre Benite Cedex
France	Research Site	Poitiers
France	Research Site	Rennes Cedex 9
France	Research Site	Rouen Cedex
France	Research Site	Saint Nazaire Cedex
France	Research Site	Saint Priest en Jarez
France	Research Site	Saint-Aubin-les-Elbeuf
France	Research Site	Saint-Quentin cedex
France	Research Site	Tarbes
France	Research Site	Toulon cedex 9
France	Research Site	Toulouse
France	Research Site	Tours cedex
France	Research Site	Valence
France	Research Site	Vantoux
France	Research Site	Villefranche-sur-Saone cedex
Germany	Research Site	Berlin
Germany	Research Site	Bochum
Germany	Research Site	Bremen
Germany	Research Site	Dresden
Germany	Research Site	Erlangen
Germany	Research Site	Essen
Germany	Research Site	Esslingen
Germany	Research Site	Furth
Germany	Research Site	Georgsmarienhuette
Germany	Research Site	Gutersloh
Germany	Research Site	Halle (Saale)
Germany	Research Site	Hamburg
Germany	Research Site	Hamburg
Germany	Research Site	Hamburg
Germany	Research Site	Immenhausen
Germany	Research Site	Kaiserslautern
Germany	Research Site	Karlsruhe
Germany	Research Site	Kempten
Germany	Research Site	Muenchen
Germany	Research Site	Munnerstadt
Germany	Research Site	Oldenburg
Germany	Research Site	Paderborn
Germany	Research Site	Recklinghausen
Germany	Research Site	Regensburg
Germany	Research Site	Regensburg
Germany	Research Site	Rostock
Germany	Research Site	Wurselen
Israel	Research Site	Ashkelon
Israel	Research Site	Beer Sheva
Israel	Research Site	Haifa
Israel	Research Site	Haifa
Israel	Research Site	Holon
Israel	Research Site	Jerusalem
Israel	Research Site	Kfar-Saba
Israel	Research Site	Nahariya
Israel	Research Site	Nazareth
Israel	Research Site	Petah Tikva
Israel	Research Site	Ramat Gan
Israel	Research Site	Tel Aviv
Israel	Research Site	Tel Aviv
Italy	Research Site	Alessandria
Italy	Research Site	Ancona
Italy	Research Site	Arezzo
Italy	Research Site	Aviano
Italy	Research Site	Bari
Italy	Research Site	Bolzano
Italy	Research Site	Brescia
Italy	Research Site	Brescia
Italy	Research Site	Catanzaro
Italy	Research Site	Feltre
Italy	Research Site	Firenze
Italy	Research Site	Genova
Italy	Research Site	Genova
Italy	Research Site	Imola
Italy	Research Site	l'Aquila (AQ)
Italy	Research Site	La Spezia
Italy	Research Site	Lecce
Italy	Research Site	Lido di Camaiore
Italy	Research Site	Meldola
Italy	Research Site	Messina
Italy	Research Site	Milano
Italy	Research Site	Milano
Italy	Research Site	Milano
Italy	Research Site	Mirano
Italy	Research Site	Modena
Italy	Research Site	Monza
Italy	Research Site	Napoli
Italy	Research Site	Padova
Italy	Research Site	Parma
Italy	Research Site	Pavia
Italy	Research Site	Perugia
Italy	Research Site	Pisa
Italy	Research Site	Pistoia
Italy	Research Site	Ravenna
Italy	Research Site	Reggio Emilia
Italy	Research Site	Rimini
Italy	Research Site	Rionero In Vulture (PZ)
Italy	Research Site	Roma
Italy	Research Site	Roma
Italy	Research Site	Rozzano
Italy	Research Site	Sora
Italy	Research Site	Terni
Italy	Research Site	Treviglio
Italy	Research Site	Trieste
Italy	Research Site	Udine
Italy	Research Site	Varese
Italy	Research Site	Verona
Netherlands	Research Site	Alkmaar
Netherlands	Research Site	Amersfoort
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Arnhem
Netherlands	Research Site	Breda
Netherlands	Research Site	Den Haag
Netherlands	Research Site	Ede
Netherlands	Research Site	Eindhoven
Netherlands	Research Site	Groningen
Netherlands	Research Site	Groningen
Netherlands	Research Site	Heerlen
Netherlands	Research Site	Hertogenbosch
Netherlands	Research Site	Hilversum
Netherlands	Research Site	Leiden
Netherlands	Research Site	Maastricht
Netherlands	Research Site	Nieuwegein
Netherlands	Research Site	Nijmegen
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Utrecht
Netherlands	Research Site	Zutphen
Norway	Research Site	Arendal
Norway	Research Site	Drammen
Norway	Research Site	Oslo
Norway	Research Site	Tromso
Switzerland	Research Site	Altdorf
Switzerland	Research Site	Bulach
Switzerland	Research Site	Chur
Switzerland	Research Site	Fribourg
Switzerland	Research Site	Geneva
Switzerland	Research Site	Lausanne
Switzerland	Research Site	Neuchatel
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Cardiff
United Kingdom	Research Site	Colchester
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Poole
United Kingdom	Research Site	Stoke on Trent

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Belgium,  France,  Germany,  Israel,  Italy,  Netherlands,  Norway,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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.	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.