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

Launched by BOEHRINGER INGELHEIM · May 7, 2015

Keywords

ClinConnect Summary

Study Design:

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Adult outpatients (18 years and older) of either gender;
• • Histologically or cytologically confirmed locally advanced or metastatic (IIIB/IV) NSCLC of any histological type with activating EGFR mutation(s) according to local laboratory EGFR testing;
• • EGFR- tyrosine kinase inhibitor (TKI) naive patients;
• • Patients for whom the decision to prescribe therapy with afatinib (GIOTRIF®) according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study; the assignment of the patient to this therapeutic strategy is not decided in advance by the study protocol but falls within current practice and the prescription of afatinib is clearly separated from the physicians decision to include the patient in the current study;
• • Patients must be able and willing to provide written informed consent and to comply with the requirements of this study protocol;
• Exclusion criteria:
• • Patients who have initiated treatment with Afatinib more than 7 days prior to their enrolment into the study;
• • Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC;
• • Receipt of any investigational agent within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with afatinib