GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations

Boehringer Ingelheim

Status: Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Afatinib

Study type: Observational

Funder types: Industry

Identifiers

NCT02047903

1200.205

Details and patient eligibility

About

This observational study will investigate the efficacy, safety, tolerability and symptom control of GIOTRIF (Afatinib) in daily routine first-line therapy in patients with locally advanced or metastatic NSCLC harboring EGFR-mutations. Eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with GIOTRIF in first line according to the local label, will be followed up for approximately 24 months.

Full description

Study Design:

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• EGFR- tyrosine kinase inhibitor (TKI) naive patients with histologically confirmed locally advanced or metastatic NSCLC with activating EGFR-mutations
• Age >= 18 years
• No diagnostic or therapeutic measures beyond routine clinical practice are required
• Patients for whom the treating physician has decided to initiate treatment with GIOTRIF
• Written informed consent prior inclusion

Exclusion criteria

• Contraindication for Afatinib according to the Summary of Product characteristics
• Participation in another clinical study until 30 days after end of treatment
• Prior systemic chemotherapy (Neo-/adjuvant therapy is permitted)
• Previous treatment with an EGFR-tyrosine kinase inhibitor
• Patients not willing or not able to fill in quality of life questionnaires
• Patients with missing or impaired legal capacity
• Pregnancy

Trial design

161 participants in 1 patient group

Afatinib

Treatment:

Drug: Afatinib