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

NCT03271554

CompletedN/A

Sponsor: Hoffmann-La Roche

Conditions: Non-Small Cell Lung Cancer

Interventions: Alectinib

Countries: South Korea

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.

Eligibility overview

Sex: ALL

Age: 19 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (37)

Busan, South Korea
Busan, South Korea
Busan, South Korea
Busan, South Korea
Busan, South Korea
Cheongju-si, South Korea
Daegu, South Korea
Daegu, South Korea
Daegu, South Korea
Daejeon, South Korea
Gangwon-do, South Korea
Gyeonggi-do, South Korea
Gyeonggi-do, South Korea
Gyeonggi-do, South Korea
Gyeonggi-do, South Korea
Gyeonggi-do, South Korea
Gyeonggi-do, South Korea
Gyeongsangnam-do, South Korea
Incheon, South Korea
Incheon, South Korea
Incheon, South Korea
Jeollabuk-do, South Korea
Jeollanam-do, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
+ 7 more on CT.gov