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Evaluate the Impact of Afatinib on Quality of Life and Symptom Burden of Greek Subjects With Advanced NSCLC in Routine Patient Care Settings

NCT02440854 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2022-04-27

Study results available
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Summary

This non-interventional study will include a representative sample of patients with locally advanced or metastatic NSCLC harboring Epidermal Growth Factor Receptor (EGFR)-mutations in Greece. Eligible NSCLC patients, for whom the physician has decided to initiate treatment with the study medication (afatinib, GIOTRIF®) will be treated according to the local prescribing information and standard medical practice in terms of visit frequency and types of assessments performed.

The study will investigate the impact of GIOTRIF (Afatinib) on patients' disease-related symptom burden and Health-Related Quality of Life (HRQoL) in a real world clinical setting in Greece.The Average Symptom Burden Index (ASBI) score of the Lung Cancer Symptom Scale (LCSS) in eligible patients, after 6 months of therapy, will be analyzed.

The overall study duration period is expected to be 60 months, including a 48-month enrollment period and a minimum 12-month follow-up period.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

afatinib

Patients were treated as per the routine medical practice in terms of visit frequency, types of assessments performed and with adherence to the local prescribing requirements for afatinib.

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-16
Primary Completion
2021-02-17
Completion
2021-02-17

Countries

  • Greece

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02440854 on ClinicalTrials.gov