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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: 1L treatment
* Drug: 2L Treatment
* Drug: 3L treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with EGFR mutation positive NSCLC<br> | Drug: 1L treatment<br>* chemotherapy, EGFR TKI, immunotherapy, other<br>Drug: 2L Treatment<br>* Chemotherapy, EGFR TKI, immunotherapy, other<br>Drug: 3L treatment<br>* chemotherapy, EGFR TKI, immunotherapy, other<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| EGFR testing characteristics at diagnosis between 1 september 2015 and 31 December 2017 |  | 28 months | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EGFRm, NSCLC, locally advanced, metastatic, lung cancer