Clinical trial NCT03798535: First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy
Official title: First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NSCLC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-01-10
Enrollment: 1156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient selection criteria: Patient selection and retrospective data collection will be from participating countries: Australia, Belgium, Israel, Netherlands, Norway France, Germany, Italy, Switzerland, Spain. Data will be collected from those patients who have received at least one dose of durvalumab between September 2017 through 21 DEC 2018. Patients may participate in other clinical trials during this follow-up period.

Patients must have completed a platinum-based chemotherapy concurrently or sequentially with radiation therapy without evidence of disease progression. There is no fixed maximum duration for durvalumab treatment and it continues until the physician determines that it is in the patient's best interest to stop therapy.

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating progression free survival (PFS)
timeFrame: 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.
measure: To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating overall survival (OS)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Ballarat
country: Australia
facility: Research Site
city: Bankstown
country: Australia
facility: Research Site
city: Bedford Park
country: Australia
facility: Research Site
city: Bendigo
country: Australia
facility: Research Site
city: Bentleigh East
country: Australia
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city: Bowral
country: Australia
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city: Box Hill
country: Australia
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city: Campbelltown
country: Australia
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city: Camperdown
country: Australia
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city: Canberra
country: Australia
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city: Clayton
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city: Coffs Harbour
country: Australia
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city: Douglas
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city: Elizabeth Vale
country: Australia
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city: Frankston
country: Australia
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city: Hamlyn Terrace
country: Australia
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city: Hervey Bay
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city: Hobart
country: Australia
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city: Joondalup
country: Australia
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city: Kingswood
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city: Liverpool
country: Australia
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city: Malvern
country: Australia
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city: Melbourne
country: Australia
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city: Melbourne
country: Australia
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city: Murdoch
country: Australia
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city: Orange
country: Australia
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city: Rockhampton
country: Australia
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city: St Leonards
country: Australia
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city: Subiaco
country: Australia
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city: Traralgon
country: Australia
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city: Tugun
country: Australia
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city: Warrnambool
country: Australia
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city: Wendouree
country: Australia
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city: Westmead
country: Australia
facility: Research Site
city: Wollongong
country: Australia
facility: Research Site
city: Aalst
country: Belgium
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city: Bouge
country: Belgium
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city: Braine-l'Alleud
country: Belgium
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city: Brasschaat
country: Belgium
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city: Brussels
country: Belgium
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city: Brussels
country: Belgium
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city: Bruxelles
country: Belgium
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city: Dendermonde
country: Belgium
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city: Gent
country: Belgium
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city: Hasselt
country: Belgium
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city: Herstal
country: Belgium
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city: Heusden-Zolder
country: Belgium
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city: Ieper
country: Belgium
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city: Kuringen
country: Belgium
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city: Liege
country: Belgium
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city: Loverval
country: Belgium
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city: Mons
country: Belgium
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city: Ottignies
country: Belgium
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city: Roeselare
country: Belgium
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city: Ronse
country: Belgium
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city: Sint-Niklaas
country: Belgium
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city: Sint-Truiden
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city: Yvoir
country: Belgium
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city: Abbeville
country: France
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city: Aix en Provence
country: France
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city: Albi Cedex 09
country: France
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city: Antony
country: France
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city: Avignon Cedex 09
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country: France
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city: La Roche sur Yon Cedex 9
country: France
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city: Le Mans Cedex
country: France
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country: France
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city: Libourne Cedex
country: France
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city: Lille
country: France
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city: Limoges
country: France
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city: Lorient
country: France
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city: Lyon Cedex 08
country: France
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city: Macon
country: France
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city: MARSEILLE Cedex 20
country: France
facility: Research Site
city: Marseille
country: France
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city: Metz-Tessy
country: France
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city: Montpellier
country: France
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city: Montpellier
country: France
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city: Morlaix Cedex
country: France
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city: Muret
country: France
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city: Nancy
country: France
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city: Nimes
country: France
facility: Research Site
city: Paris Cedex 10
country: France
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city: Paris Cedex 14
country: France
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city: Paris Cedex 5
country: France
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city: Paris
country: France
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city: Paris
country: France
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city: Pau cedex
country: France
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city: Perigueux
country: France
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city: Perpignan
country: France
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city: Pierre Benite Cedex
country: France
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city: Poitiers
country: France
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city: Rennes Cedex 9
country: France
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city: Rouen Cedex
country: France
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city: Saint Nazaire Cedex
country: France
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city: Saint Priest en Jarez
country: France
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city: Saint-Aubin-les-Elbeuf
country: France
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city: Saint-Quentin cedex
country: France
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country: France
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country: France
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city: Villefranche-sur-Saone cedex
country: France
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city: Berlin
country: Germany
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city: Bochum
country: Germany
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city: Bremen
country: Germany
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city: Dresden
country: Germany
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city: Erlangen
country: Germany
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city: Essen
country: Germany
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city: Esslingen
country: Germany
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city: Furth
country: Germany
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city: Georgsmarienhuette
country: Germany
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city: Gutersloh
country: Germany
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city: Halle (Saale)
country: Germany
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city: Hamburg
country: Germany
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country: Germany
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country: Germany
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city: Immenhausen
country: Germany
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city: Kaiserslautern
country: Germany
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city: Karlsruhe
country: Germany
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city: Kempten
country: Germany
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city: Muenchen
country: Germany
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city: Munnerstadt
country: Germany
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city: Oldenburg
country: Germany
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city: Paderborn
country: Germany
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city: Recklinghausen
country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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city: Ashkelon
country: Israel
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country: Israel
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country: Israel
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country: Israel
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city: Holon
country: Israel
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city: Jerusalem
country: Israel
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city: Kfar-Saba
country: Israel
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city: Nahariya
country: Israel
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city: Nazareth
country: Israel
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city: Petah Tikva
country: Israel
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city: Ramat Gan
country: Israel
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country: Israel
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country: Israel
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city: Alessandria
country: Italy
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city: Ancona
country: Italy
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city: Arezzo
country: Italy
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city: Aviano
country: Italy
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city: Bari
country: Italy
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city: Bolzano
country: Italy
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city: Brescia
country: Italy
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city: Brescia
country: Italy
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city: Catanzaro
country: Italy
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city: Feltre
country: Italy
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city: Firenze
country: Italy
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city: Genova
country: Italy
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city: Genova
country: Italy
facility: Research Site
city: Imola
country: Italy
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city: l'Aquila (AQ)
country: Italy
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city: La Spezia
country: Italy
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city: Lecce
country: Italy
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city: Lido di Camaiore
country: Italy
facility: Research Site
city: Meldola
country: Italy
facility: Research Site
city: Messina
country: Italy
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city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
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city: Milano
country: Italy
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city: Mirano
country: Italy
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city: Modena
country: Italy
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city: Monza
country: Italy
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city: Napoli
country: Italy
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city: Padova
country: Italy
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city: Parma
country: Italy
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city: Pavia
country: Italy
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city: Perugia
country: Italy
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city: Pisa
country: Italy
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city: Pistoia
country: Italy
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city: Ravenna
country: Italy
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city: Reggio Emilia
country: Italy
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city: Rimini
country: Italy
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city: Rionero In Vulture (PZ)
country: Italy
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city: Roma
country: Italy
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city: Roma
country: Italy
facility: Research Site
city: Rozzano
country: Italy
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city: Sora
country: Italy
facility: Research Site
city: Terni
country: Italy
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city: Treviglio
country: Italy
facility: Research Site
city: Trieste
country: Italy
facility: Research Site
city: Udine
country: Italy
facility: Research Site
city: Varese
country: Italy
facility: Research Site
city: Verona
country: Italy
facility: Research Site
city: Alkmaar
country: Netherlands
facility: Research Site
city: Amersfoort
country: Netherlands
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Amsterdam
country: Netherlands
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city: Arnhem
country: Netherlands
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city: Breda
country: Netherlands
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city: Den Haag
country: Netherlands
facility: Research Site
city: Ede
country: Netherlands
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city: Eindhoven
country: Netherlands
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city: Groningen
country: Netherlands
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city: Groningen
country: Netherlands
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city: Heerlen
country: Netherlands
facility: Research Site
city: Hertogenbosch
country: Netherlands
facility: Research Site
city: Hilversum
country: Netherlands
facility: Research Site
city: Leiden
country: Netherlands
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city: Maastricht
country: Netherlands
facility: Research Site
city: Nieuwegein
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
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city: Rotterdam
country: Netherlands
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city: Utrecht
country: Netherlands
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city: Zutphen
country: Netherlands
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city: Arendal
country: Norway
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city: Drammen
country: Norway
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city: Oslo
country: Norway
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city: Tromso
country: Norway
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city: Altdorf
country: Switzerland
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city: Bulach
country: Switzerland
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city: Chur
country: Switzerland
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city: Fribourg
country: Switzerland
facility: Research Site
city: Geneva
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: Neuchatel
country: Switzerland
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Colchester
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Poole
country: United Kingdom
facility: Research Site
city: Stoke on Trent
country: United Kingdom
facility: Research Site
Study officials:
References: