Treatment Registry of Alectinib in Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Korea

Roche

Status: Completed

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Alectinib

Study type: Observational

Funder types: Industry

Identifiers

NCT03271554

ML30132

Details and patient eligibility

About

Alectinib was approved by the Ministry of Food and Drug Safety (MFDS) in Korea in Oct 2016. The purpose of this registry is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and effectiveness of the new drug so that the regulatory authority can manage the marketing approval properly.

Enrollment: 355 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who are administered alectinib at physician's discretion and fall into the approved indication in Korea.

Exclusion criteria

• Hypersensitivity to alectinib or any ingredient of alectinib;
• Pregnant or lactating women;
• Pediatric subjects (age </=18 years);
• Due to the presence of lactose, subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take alectinib.

Trial design

355 participants in 1 patient group

Alectinib

Description:

Participants with ALK-positive, locally advanced or metastatic non-small cell lung cancer, who are treated with alectinib in accordance with local clinical practice and local labeling, are observed in this study.

Treatment:

Drug: Alectinib