Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
EGFRm, NSCLC, locally advanced, metastatic, lung cancer
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
Interventions
DRUG1L treatment
chemotherapy, EGFR TKI, immunotherapy, other
DRUG2L Treatment
Chemotherapy, EGFR TKI, immunotherapy, other
DRUG3L treatment
chemotherapy, EGFR TKI, immunotherapy, other
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 at diagnosis between 1 september 2015 and 31 December 2017 | 28 months | — |
| 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 | 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Belgium
Outcome results
None listed