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

N/ACompletedNCT03761901

AstraZeneca141 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

141

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

1L treatmentDRUG

chemotherapy, EGFR TKI, immunotherapy, other

2L TreatmentDRUG

Chemotherapy, EGFR TKI, immunotherapy, other

3L treatmentDRUG

chemotherapy, EGFR TKI, immunotherapy, other

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

Research Site

Antwerp, Belgium

Research Site

Bouge, Belgium

Research Site

Brussels, Belgium

Outcomes

Primary Outcomes

demographic characteristics of patients diagnosed between 1 September 2015 and 31 December 2017

Time frame: 28 months

NSCLC characteristics at diagnosis between 1 september 2015 and 31 December 2017

Time frame: 28 months

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.

Time frame: 36 months

Type of treatment received during 1L, 2L or 3L treatment during the observation window

Time frame: 36 months

Time on treatment during 1L, 2L or 3L treatment during the observation window

Time frame: 36 months

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

Time frame: 36 months

Reason for discontinuation after 1L, 2L or 3L treatment during observation window

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

Time frame: 36 months

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.

Time frame: 36 months

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.

Time frame: 36 months

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.

Time frame: 36 months