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The Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients With Advanced EGFR Mutation-positive Non-small Cell Lung Cancer Treated With Afatinib

An Observational Study to Assess the Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients With Advanced EGFR Mutation-positive Non-small Cell Lung Cancer Treated With Afatinib in Real-world Clinical Set-tings in Greece

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04640870
Enrollment
59
Registered
2020-11-23
Start date
2015-03-15
Completion date
2020-05-31
Last updated
2020-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR Gene Mutation, EGF-R Positive Non-Small Cell Lung Cancer, Non Small Cell Lung Cancer

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

DRUGAfatinib

Treatment with Afatinib, any line, in metastatic, EGFR mutated patients with NSCLC

Sponsors

Hellenic Cooperative Oncology Group
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Progression Free SurvivalFrom Day 1 of treatment with Afatinib until disease progression, death from any cause or last follow-up, whichever occurs first, up to 12 monthsProgression Free Survival

Secondary

MeasureTime frameDescription
Overall survivalFrom Day 1 of treatment with Afatinib until death from any cause or last follow-up, up to 24 monthsOverall 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 monthsSecond progression-free survival (PFS2)
Assessment of the safety profile of AfatinibIn every cycle, every 28 daysassessment of the safety profile of Afatinib

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026