Study to Describe Treatment Patterns and Outcomes in EGFRm NSCLC Patients in Belgium

Carcinoma, Non-Small-Cell Lung Clinical Trial

— REVEAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761901
• Other study ID #: D5161R00007
• Status: Completed
• Start date: September 21, 2018
• Est. completion date: June 19, 2019

Study information

• Verified date: May 2020
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: June 19, 2019
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• 1L treatment
chemotherapy, EGFR TKI, immunotherapy, other
• 2L Treatment
Chemotherapy, EGFR TKI, immunotherapy, other
• 3L treatment
chemotherapy, EGFR TKI, immunotherapy, other

Locations

Country	Name	City	State
Belgium	Research Site	Antwerpen
Belgium	Research Site	Bouge
Belgium	Research Site	Brussels
Belgium	Research Site	Bruxelles
Belgium	Research Site	Charleroi
Belgium	Research Site	Edegem
Belgium	Research Site	Gent
Belgium	Research Site	Hasselt
Belgium	Research Site	Mechelen
Belgium	Research Site	Mons
Belgium	Research Site	Roeselare
Belgium	Research Site	Sint-Niklaas
Belgium	Research Site	Sint-Truiden
Belgium	Research Site	Turnhout
Belgium	Research Site	Yvoir

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	demographic characteristics of patients diagnosed between 1 September 2015 and 31 December 2017		28 months
Primary	NSCLC characteristics at diagnosis between 1 september 2015 and 31 December 2017		28 months
Primary	NSCLC disease characteristics at start of 2L or 3L treatment during observation window	observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.	36 months
Primary	Type of treatment received during 1L, 2L or 3L treatment during the observation window	observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.	36 months
Primary	Time on treatment during 1L, 2L or 3L treatment during the observation window	observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.	36 months
Primary	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	observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.	36 months
Primary	Reason for discontinuation after 1L, 2L or 3L treatment during observation window	observation window: between date of diagnosis until the data cut-off, 1 september 2018, end of clinical activity or death, whichever comes first. Descriptive statistics will be used to analyse these endpoints.	36 months
Primary	EGFR testing characteristics at diagnosis between 1 september 2015 and 31 December 2017		28 months
Primary	EGFR testing characteristics after progression on previous treatment	observation window: between date of diagnosis until the data cut-off, 01 September 2018 until end of clinical activity or death, whichever comes first. Descriptive statistics will be used to analyse these endpoints.	36 months
Secondary	PFS for 1L, 2L or 3L treatment during the observation window	observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Kaplan-Meier analysis will be used.	36 months
Secondary	Time-to-treatment discontinuation for 1L, 2L and 3L treatment during the observation window	observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Kaplan-Meier analysis will be used.	36 months
Secondary	Time to start of subsequent treatment after 1L and 2L treatment during the observation window	observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Kaplan-Meier analysis will be used.	36 months
Secondary	OS during observation window	OS will be measured overall for all EGFRm NSCLC patients and depending on receipt of Osimertinib treatment and line of Osimertinib treatment.; observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first.; Kaplan-Meier analysis will be used.	36 months

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