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

NCT04640870 | Completed

• 1 other identifier: ΗΕ2/15
• Study Type: observational
• Target: 59
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  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

Secondary Outcomes (3)

• Overall survival

  From Day 1 of treatment with Afatinib until death from any cause or last follow-up, up to 24 months

• 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

• Assessment of the safety profile of Afatinib

  In every cycle, every 28 days

Interventions

Afatinib DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective analysis of patients with histologically confirmed Non-small cell lung cancer and EGFR mutated, with progressive disease. Patients analysed in this study have been treated with Afatinib in any line. Patients have been treated in Hellenic Cooperative Oncology Group(HeCOG)- affiliated departments of oncology.

You may qualify if:

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

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Related Publications (24)

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• Mountzios G, Lampaki S, Koliou GA, Vozikis A, Kontogiorgos I, Papantoniou P, Koufaki MI, Res E, Boutis A, Christopoulou A, Pastelli N, Grivas A, Aravantinos G, Lalla E, Oikonomopoulos G, Koumarianou A, Spyratos D, Bafaloukos D, Rigakos G, Papakotoulas P, Fountzilas G, Linardou H. An Observational Study to Assess the Molecular Epidemiology and Direct Medical Costs 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 Settings in Greece. Lung Cancer (Auckl). 2021 Aug 30;12:93-102. doi: 10.2147/LCTT.S318007. eCollection 2021.

  PMID: 34512058 DERIVED

Related Links

• Global Cancer Observatory: Cancer Today; International Agency for Research on Cancer. Estimated Number of New Cases in 2018.
• World Cancer Research Fund International. Lung cancer statistics

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ioannis Mountzios, MD

  Henry Dunant Hospital Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 23, 2020
• Study Start: March 15, 2015
• Primary Completion: March 1, 2020
• Study Completion: May 1, 2020
• Last Updated: December 23, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share