Long-term Observation PMS for Afatinib

Boehringer Ingelheim

Status: Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Afatinib dimaleate

Study type: Observational

Funder types: Industry

Identifiers

NCT02131259

1200.181

Details and patient eligibility

About

In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for reexamination. Reexamination period is defined by J-PAL. Eight years after approval of a new substance, results of PMS need to be submitted as a part of reexamination dossier to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).

Enrollment: 1,605 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive inoperable or recurrent non-small cell lung cancer (NSCLC)will be included.

Exclusion criteria

• None

Trial design

1,605 participants in 1 patient group

Afatinib

Treatment:

Drug: Afatinib dimaleate