Non-Small Cell Lung Cancer
Conditions
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.
Interventions
DRUGAlectinib
According to local labeling the recommended dose of alectinib is 600 mg given orally, twice daily with food (total daily dose of 1200 mg).
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed