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

NCT03271554 | Completed FDA Drug

• 1 other identifier: ML30132
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 37

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Adverse Events (AEs)

  An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. All AE events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

  Up to approximately 3 years

Secondary Outcomes (5)

• Overall Response Rate (ORR)

  Up to approximately 3 years

• Complete Response (CR)

  Up to approximately 3 years

• Percentage of Participants with Partial Response (PR)

  Up to approximately 3 years

• Percentage of Participants with Stable Disease (SD)

  Up to approximately 3 years

• Percentage of Participants with Progressive Disease (PD)

  Up to approximately 3 years

Study Arms (1)

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.

Drug: Alectinib

Interventions

Alectinib 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).

Also known as: Alecensa

Alectinib

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with ALK-positive, locally advance or metastatic non-small cell lung cancer, who are administered alectinib at physician's discretion in Korea.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (37)

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

Dongnam Institute of Radiological & Medical Sciences

Busan, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 41931, South Korea

Location

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Konyang University Hospital

Daejeon, 35365, South Korea

Location

Yonsei University Wonju Severance Christian Hospital

Gangwon-do, 26426, South Korea

Location

Inje University Ilsan Paik Hospital

Gyeonggi-do, 10380, South Korea

Location

Uijeongbu St. Mary's Hospital

Gyeonggi-do, 11765, South Korea

Location

CHA Bundang Medical Center

Gyeonggi-do, 13496, South Korea

Location

Hallym University Sacred Heart Hospital

Gyeonggi-do, 14068, South Korea

Location

Bucheon St Mary's hospital

Gyeonggi-do, 14647, South Korea

Location

St. Vincent's Hospital

Gyeonggi-do, 16247, South Korea

Location

Pusan National University Yangsan Hospital

Gyeongsangnam-do, 50612, South Korea

Location

Catholic Univ. of Incheon St.Mary's Hospital

Incheon, 21431, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Chonbuk National University Hospital

Jeollabuk-do, 54907, South Korea

Location

Chonnam National University Hwasun Hospital

Jeollanam-do, 58128, South Korea

Location

Inje University, Sanggye-Paik Hospital

Seoul, 01757, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Severance Hospital, Yonsei University

Seoul, 03722, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Gangdong Kyung Hee University Hospital

Seoul, 05278, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, 07985, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Soon Chun Hyang University Hospital; Department of Pulmonology and Allergy

Seoul, 140-743, South Korea

Location

Yonsei University Wonju Severance Christian Hospital

Wŏnju, 220-701, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

alectinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 5, 2017
• Study Start: November 9, 2017
• Primary Completion: May 28, 2021
• Study Completion: May 28, 2021
• Last Updated: November 18, 2022

Record last verified: 2022-11

Locations

KR (37)