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

NCT ID: NCT04640870

Last Updated: 2020-12-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 59 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-15
• Study Completion Date: 2020-05-31

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).

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Afatinib

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hellenic Cooperative Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ioannis Mountzios, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Dunant Hospital Center

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Related Links

https://gco.iarc.fr/

Global Cancer Observatory: Cancer Today; International Agency for Research on Cancer. Estimated Number of New Cases in 2018.

https://www.wcrf.org/dietandcancer/cancer-trends/lung-cancer-statistics

World Cancer Research Fund International. Lung cancer statistics

Other Identifiers

ΗΕ2/15

Identifier Type: -

Identifier Source: org_study_id