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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

355 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-09

Study Completion Date

2021-05-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of the Efficacy and Safety of Alectinib in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer

NCT03155009

Carcinoma, Non-Small-Cell Lung

COMPLETED PHASE2

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants

NCT02075840

Non-Small Cell Lung Cancer

COMPLETED PHASE3

Expanded Access Study of Alectinib for Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy

NCT02271139

Non-Small Cell Lung Cancer

NO_LONGER_AVAILABLE

LDK378 in Patients With ALK Positive NSCLC Previously Treated With Alectinib.

NCT02450903

Non-Small-Cell Lung Cancer

COMPLETED PHASE2

A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment

NCT01801111

Non-Small-Cell Lung Carcinoma

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Alectinib

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.

Alectinib

Intervention Type DRUG

According to local labeling the recommended dose of alectinib is 600 mg given orally, twice daily with food (total daily dose of 1200 mg).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alectinib

According to local labeling the recommended dose of alectinib is 600 mg given orally, twice daily with food (total daily dose of 1200 mg).

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Alecensa

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No