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

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: 1L treatment; Drug: 2L Treatment; Drug: 3L treatment

• Registration Number: NCT03761901
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-21
• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-30
• Study First Posted: 2018-12-03
• Primary Completion: 2019-06-19
• Study Completion: 2019-06-19
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with EGFR mutation positive NSCLC	2L Treatment	-
Patients with EGFR mutation positive NSCLC	1L treatment	-
Patients with EGFR mutation positive NSCLC	3L treatment	-

Primary Outcome Measures

Name	Time	Method
demographic characteristics of patients diagnosed between 1 September 2015 and 31 December 2017	28 months
NSCLC characteristics at diagnosis between 1 september 2015 and 31 December 2017	28 months
Type of treatment received during 1L, 2L or 3L treatment during the observation window	36 months	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.
Time on treatment during 1L, 2L or 3L treatment during the observation window	36 months	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.
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	36 months	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.
NSCLC disease characteristics at start of 2L or 3L treatment during observation window	36 months	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.
EGFR testing characteristics at diagnosis between 1 september 2015 and 31 December 2017	28 months
Reason for discontinuation after 1L, 2L or 3L treatment during observation window	36 months	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.
EGFR testing characteristics after progression on previous treatment	36 months	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.

Secondary Outcome Measures

Name	Time	Method
Time to start of subsequent treatment after 1L and 2L treatment during the observation window	36 months	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.
OS during observation window	36 months	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.
PFS for 1L, 2L or 3L treatment during the observation window	36 months	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.
Time-to-treatment discontinuation for 1L, 2L and 3L treatment during the observation window	36 months	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.

Trial Locations

Locations (1)

Research Site; 🇧🇪 Yvoir, Belgium