GIOTRIF rPMS in Korean Patients With NSCLC

Boehringer Ingelheim

Status: Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: GIOTRIF 30mg; Drug: GIOTRIF 20mg; Drug: GIOTRIF 40mg

Study type: Observational

Funder types: Industry

Identifiers

NCT02285361

1200.235

Details and patient eligibility

About

To monitor the safety profile and efficacy of GIOTRIF® (afatinib dimaleate, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)

Enrollment: 1,272 patients

Sex: All

Ages: 19 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who have been started on GIOTRIF® in accordance with the approved label in Korea
2. Age = 19 years at enrolment
3. Patients who have signed on the data release consent form

Exclusion criteria

1. Known hypersensitivity to afatinib or any of its excipients
2. Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
3. Patients for whom GIOTRIF® is contraindicated according to the local label

Trial design

1,272 participants in 1 patient group

GIOTRIF

Treatment:

Drug: GIOTRIF 40mg

Drug: GIOTRIF 20mg

Drug: GIOTRIF 30mg