BRAFV600E-Mutant Advanced Non-Small Cell Lung Cancer (NSCLC)
Conditions
Interventions
Group 1: Adult patients with advanced non-small cell lung cancer (NSCLC) harboring a BRAFV600E mutation treated with encorafenib in combination with binimetinib in the first-line setting according to
Sponsors
Pierre Fabre Pharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult patients with advanced non-small cell lung cancer with a BRAFV600E mutation treated in 1L with encorafenib in combination with binimetinib according to SmPC 2. Patient treatment start: For documentation wave 1 and 2: 08/2024* to 03/2026 For documentation wave 3: 08/2024* to 09/2026 *EMA-approval and availability in Germany 3. Signed written informed consent for patients alive at study inclusion. For deceased patients, data may be included without informed consent.
Exclusion criteria
Exclusion criteria: 1. Enrolment in a clinical trial for an experimental therapy on or at any time after the diagnosis of advanced NSCLC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To describe real-world patterns of treatment with encorafenib in combination with binimetinib in patients with BRAFV600E-mutant advanced NSCLC, including treatment persistence, reasons for discontinuation, and dosing patterns 2. To describe demographic and clinical characteristics, including comorbidities and BRAF mutation testing | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To describe the safety profile, including the incidence of adverse events (AEs) leading to dose modification and/or permanent or temporary discontinuation, as well as serious AEs (SAEs) and/or all recorded AEs, of encorafenib in combination with binimetinib in patients with BRAFV600E-mutant advanced NSCLC on individual patient level. 2. Optional: Real-world effectiveness of encorafenib in combination with binimetinib, including • objective response (rwOR) • duration of response (rwDoR) • time to progression (rwTTP) • time to discontinuation (rwTTD) • time to next treatment (rwTTNT) • time to death | — |
Countries
Germany
Outcome results
None listed