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

Completed

• Conditions: Non Small Cell Lung Cancer; EGF-R Positive Non-Small Cell Lung Cancer; EGFR Gene Mutation

• Registration Number: NCT04640870
• Lead Sponsor: Hellenic Cooperative Oncology Group

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).

Study Timeline

• Study Start: 2015-03-15
• Primary Completion: 2020-03
• Study Completion: 2020-05
• Status Verified: 2020-11
• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-23
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2020-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• >18 years old
• Patients diagnosed with Non-small cell lung cancer
• metastatic disease
• Afatinib treated in any line
• EGFR mutated

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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