EGFR Gene Mutation, EGF-R Positive Non-Small Cell Lung Cancer, Non Small Cell Lung Cancer
Conditions
Brief summary
This is an observational, non-interventional, single-country, multi center, retrospective cohort study, based on real world data collection, of patients with locally advanced or metastatic Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC) who had been treated with Afatinib at any line.
Detailed description
This is an observational, non-interventional, single-country, multicenter, retrospective cohort study, based on real world data collection, of patients with locally advanced or metastatic EGFR mutation-positive NSCLC who had been treated with Afatinib s at any line. The study is carried out by hospital-based oncologists/pneumonologists specializing in lung cancer under real-world conditions of daily clinical practice. Investigators were selected through a documented and structured feasibility process which accounted for physicians' qualifications, previous participation and experience in similar clinical studies, recruitment potential, and retention capability. In addition, in order to represent variations in current real-world patterns of care, research sites were recruited from various geographic regions in Greece, also taking into consideration the regional setting and type of healthcare site/institution (publicly/privately owned, specialized oncology/pulmonology clinic, university clinic).
Interventions
Treatment with Afatinib, any line, in metastatic, EGFR mutated patients with NSCLC
Sponsors
Study design
Eligibility
Inclusion criteria
* \>18 years old * Patients diagnosed with Non-small cell lung cancer * metastatic disease * Afatinib treated in any line * EGFR mutated
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | From Day 1 of treatment with Afatinib until disease progression, death from any cause or last follow-up, whichever occurs first, up to 12 months | Progression Free Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From Day 1 of treatment with Afatinib until death from any cause or last follow-up, up to 24 months | Overall survival |
| Second progression-free survival (PFS2) | From the initiation of next treatment following discontinuation of Afatinib to the date of progression, death or last contact, up to 6 months | Second progression-free survival (PFS2) |
| Assessment of the safety profile of Afatinib | In every cycle, every 28 days | assessment of the safety profile of Afatinib |