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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT03271554

Collaborator

(none)

355

Enrollment

Locations

42.6

Actual Duration (Months)

9.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Small Cell Lung Cancer	Drug: Alectinib

Study Design

Study Type:

Observational

Actual Enrollment :

355 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Treatment Registry of Alecensa in Korean Patients With Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Actual Study Start Date :

Nov 9, 2017

Actual Primary Completion Date :

May 28, 2021

Actual Study Completion Date :

May 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
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 According to local labeling the recommended dose of alectinib is 600 mg given orally, twice daily with food (total daily dose of 1200 mg). Other Names: Alecensa

Arm

Intervention/Treatment

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

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

Other Names:

Alecensa

Outcome Measures

Primary Outcome Measures

Percentage of Participants with Adverse Events (AEs) [Up to approximately 3 years]
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.

Secondary Outcome Measures

Overall Response Rate (ORR) [Up to approximately 3 years]
ORR will be determined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as assessed by physicians under routine clinical practice. Overall response rate was defined as the percentage of participants who had any evidence of Complete Response (CR) or Partial Response (PR): CR is defined as the disappearance of all target lesions and all nodes with short axis <10 millimeter (mm); PR is defined as >/=30% decrease in the sum of the longest diameter of target lesions. Target lesions are those lesions with longest diameter >/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures >/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ. Overall Response (OR) = CR + PR.
Complete Response (CR) [Up to approximately 3 years]
CR will be determined according to RECIST v1,1 as assessed by physicians under routine clinical practice and is defined as disappearance of all target lesions and all nodes with short axis <10 mm. Target lesions are those lesions with longest diameter >/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures >/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.
Percentage of Participants with Partial Response (PR) [Up to approximately 3 years]
PR will be determined according to RECIST v1.1 as assessed by physicians under routine clinical practice and is defined as >/=30% decrease in the sum of the longest diameter of target lesions. Target lesions are those lesions with longest diameter >/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures >/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.
Percentage of Participants with Stable Disease (SD) [Up to approximately 3 years]
SD will be determined according to RECIST v1.1 as assessed by physicians under routine clinical practice and is defined as neither response nor progression. Response is defined as at least >/=30% decrease in the sum of the longest diameter of target lesions. Progression is defined as >/= 20% increase in the sum of target lesions taking as reference the smallest sum measured during follow-up and >/= 5 mm in absolute value. Target lesions are those lesions with longest diameter >/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures >/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.
Percentage of Participants with Progressive Disease (PD) [Up to approximately 3 years]
PD will be determined according to RECIST v1.1 as assessed by physicians under routine clinical practice and is defined as >/=20% increase in the sum of target lesions taking as reference the smallest sum measured during follow-up and >/= 5 mm in absolute value. Target lesions are those lesions with longest diameter >/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures >/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Inje University Busan Paik Hospital	Busan	Korea, Republic of	47392
2	Dong-A University Hospital	Busan	Korea, Republic of	49201
3	Pusan National University Hospital	Busan	Korea, Republic of	49241
4	Kosin University Gospel Hospital	Busan	Korea, Republic of	49267
5	Dongnam Institute of Radiological & Medical Sciences	Busan	Korea, Republic of
6	Chungbuk National University Hospital	Cheongju-si	Korea, Republic of	28644
7	Kyungpook National University Chilgok Hospital	Daegu	Korea, Republic of	41404
8	Keimyung University Dongsan Medical Center	Daegu	Korea, Republic of	41931
9	Daegu Catholic University Medical Center	Daegu	Korea, Republic of	42472
10	Konyang University Hospital	Daejeon	Korea, Republic of	35365
11	Yonsei University Wonju Severance Christian Hospital	Gangwon-do	Korea, Republic of	26426
12	Inje University Ilsan Paik Hospital	Gyeonggi-do	Korea, Republic of	10380
13	Uijeongbu St. Mary's Hospital	Gyeonggi-do	Korea, Republic of	11765
14	CHA Bundang Medical Center	Gyeonggi-do	Korea, Republic of	13496
15	Hallym University Sacred Heart Hospital	Gyeonggi-do	Korea, Republic of	14068
16	Bucheon St Mary's hospital	Gyeonggi-do	Korea, Republic of	14647
17	St. Vincent's Hospital	Gyeonggi-do	Korea, Republic of	16247
18	Pusan National University Yangsan Hospital	Gyeongsangnam-do	Korea, Republic of	50612
19	Catholic Univ. of Incheon St.Mary's Hospital	Incheon	Korea, Republic of	21431
20	Gachon University Gil Medical Center	Incheon	Korea, Republic of	21565
21	Inha University Hospital	Incheon	Korea, Republic of	22332
22	Chonbuk National University Hospital	Jeollabuk-do	Korea, Republic of	54907
23	Chonnam National University Hwasun Hospital	Jeollanam-do	Korea, Republic of	58128
24	Inje University, Sanggye-Paik Hospital	Seoul	Korea, Republic of	01757
25	Kyung Hee University Hospital	Seoul	Korea, Republic of	02447
26	Korea University Anam Hospital	Seoul	Korea, Republic of	02841
27	Kangbuk Samsung Hospital	Seoul	Korea, Republic of	03181
28	Severance Hospital, Yonsei University	Seoul	Korea, Republic of	03722
29	Severance Hospital	Seoul	Korea, Republic of	03722
30	Gangdong Kyung Hee University Hospital	Seoul	Korea, Republic of	05278
31	Asan Medical Center	Seoul	Korea, Republic of	05505
32	Gangnam Severance Hospital	Seoul	Korea, Republic of	06273
33	Samsung Medical Center	Seoul	Korea, Republic of	06351
34	Ewha Womans University Mokdong Hospital	Seoul	Korea, Republic of	07985
35	Korea University Guro Hospital	Seoul	Korea, Republic of	08308
36	Soon Chun Hyang University Hospital; Department of Pulmonology and Allergy	Seoul	Korea, Republic of	140-743
37	Yonsei University Wonju Severance Christian Hospital	Wonju-Si	Korea, Republic of	220-701

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT03271554

Other Study ID Numbers:

ML30132

First Posted:

Sep 5, 2017

Last Update Posted:

Nov 26, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Nov 26, 2021