Clinical trial NCT03761901: Study to Describe Treatment Patterns and Outcomes in EGFRm NSCLC Patients in Belgium
Official title: REtrospective, obserVational Study to Describe the Treatment Patterns and Outcomes of Epidermal Growth Factor Receptor Mutant (EGFRm) Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Patients in Belgium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: EGFRm
NSCLC
locally advanced
metastatic
lung cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-12-03
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with advanced or metastatic EGFRm NSCLC between 1 september 2015 and 31 December 2017

Brief summary: This is a retrospective, observational, multicentre study to evaluate treatment patterns and outcomes of patients diagnosed with locally advanced or metastatic EGFRm NSCLC in Belgium


Eligibility criteria: Inclusion Criteria:

* Male or female, aged at least 18 years
* Pathologically confirmed NSCLC
* Tumour harbours a mutation of EGFR
* Diagnosis (radiologically or pathologically confirmed) of locally advanced or metastatic NSCLC, not amenable to curative surgery or chemoradiotherapy between 01 September 2015 and 31 December 2017

Exclusion Criteria:

* No follow-up data available after diagnosis of locally advanced or metastatic EGFRm NSCLC
* Patients who objected to participation to the study

Primary outcomes:
measure: demographic characteristics of patients diagnosed between 1 September 2015 and 31 December 2017
timeFrame: 28 months
measure: NSCLC characteristics at diagnosis between 1 september 2015 and 31 December 2017
timeFrame: 28 months
measure: NSCLC disease characteristics at start of 2L or 3L treatment during observation window
timeFrame: 36 months
measure: Type of treatment received during 1L, 2L or 3L treatment during the observation window
timeFrame: 36 months
measure: Time on treatment during 1L, 2L or 3L treatment during the observation window
timeFrame: 36 months
measure: Proportion of patients receiving a definitive, systemic therapy for NSCLC or no definitive, systemic therapy for NSCLC/best supportive care treatment after progression on their previous therapy
timeFrame: 36 months
measure: Reason for discontinuation after 1L, 2L or 3L treatment during observation window
timeFrame: 36 months
measure: EGFR testing characteristics at diagnosis between 1 september 2015 and 31 December 2017
timeFrame: 28 months
measure: EGFR testing characteristics after progression on previous treatment
timeFrame: 36 months
Secondary outcomes:
measure: PFS for 1L, 2L or 3L treatment during the observation window
timeFrame: 36 months
measure: Time-to-treatment discontinuation for 1L, 2L and 3L treatment during the observation window
timeFrame: 36 months
measure: Time to start of subsequent treatment after 1L and 2L treatment during the observation window
timeFrame: 36 months
measure: OS during observation window
timeFrame: 36 months
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Research Site
city: Bouge
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Charleroi
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Mechelen
country: Belgium
facility: Research Site
city: Mons
country: Belgium
facility: Research Site
city: Roeselare
country: Belgium
facility: Research Site
city: Sint-Niklaas
country: Belgium
facility: Research Site
city: Sint-Truiden
country: Belgium
facility: Research Site
city: Turnhout
country: Belgium
facility: Research Site
city: Yvoir
country: Belgium
facility: Research Site
Study officials:
References:
citation: Cuppens K, Lodewyckx L, Demedts I, Decoster L, Colinet B, Deschepper K, Janssens A, Galdermans D, Pieters T; REVEAL Study Group. Real-World Treatment Patterns, Epidermal Growth Factor Receptor (EGFR) Testing and Outcomes in EGFR-Mutated Advanced Non-small Cell Lung Cancer Patients in Belgium: Results from the REVEAL Study. Drugs Real World Outcomes. 2021 Jun;8(2):141-152. doi: 10.1007/s40801-021-00243-w. Epub 2021 Mar 12.