UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042439 |
|---|---|
| Receipt number | R000048172 |
| Scientific Title | Prospective Multi-Institutional Observational Study of Brigatinib In ALK-rearranged advanced NSCLC, (ABRAID Study: WJOG11919L) |
| Date of disclosure of the study information | 2020/11/13 |
| Last modified on | 2023/11/16 09:09:51 |
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Basic information
Public title
Prospective Multi-Institutional Observational Study of Brigatinib In ALK-rearranged advanced NSCLC, (ABRAID Study: WJOG11919L)
Acronym
Prospective Multi-Institutional Observational Study of Brigatinib In ALK-rearranged advanced NSCLC, (ABRAID Study: WJOG11919L)
Scientific Title
Prospective Multi-Institutional Observational Study of Brigatinib In ALK-rearranged advanced NSCLC, (ABRAID Study: WJOG11919L)
Scientific Title:Acronym
Prospective Multi-Institutional Observational Study of Brigatinib In ALK-rearranged advanced NSCLC, (ABRAID Study: WJOG11919L
Region
| Japan |
Condition
Condition
ALK-rearranged advanced NSCLC
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This clinical study is an observational study aiming to investigate the efficacy and safety of brigatinib monotherapy in a real-world patient population in Japan, by collecting real-world clinical care data, with prospective enrollment of patients planned to receive brigatinib monotherapy. This study will use clinical data and samples obtained as a result of the provision of most appropriate medical care for individual patients without any restrictions imposed on the use or extent of tests, medications, or other diagnostic or therapeutic medical procedures.
Basic objectives2
Others
Basic objectives -Others
Evaluation of Efficacy and Safety.
Elucidation of the mechanisms of resistance and predictors of the efficacy of alectinib and brigatinib
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects must meet all of the following criteria:
1) Patients with advanced (stage IIIB, IIIC, IVA, or IVB) or postoperative recurrent non-small-cell lung cancer with ALK gene translocation unamenable to radical treatment
2) Patients who received prior treatment meeting either of the following:
Cohort A (Brigatinib as 2nd or 3rd line)
1. Alectinib monotherapy as 1st line, or as 2nd line following
chemotherapy*1
2. Alectinib is the most recent regimen.
Cohort B (Brigatinib as 3rd to 5th line)
1. Alectinib monotherapy as 1st line, or as 2nd line following
chemotherapy (1 regimen)
2. Alecitinib was followed by chemotherapy (1 regimen)
and/or lorlatinib
3. Chemotherapy or lorlatinib was the most recent regimen.
Cohort 0 (Brigatinib as 1st or 2nd line)
1. No history of ALK inhibitors
2. No previous systemic treatment or one chemotherapy as 1st line.
3) Patients planned to receive brigatinib monotherapy in clinical practice according to the current labeled indication for brigatinib
4) Patients in whom evaluation by chest CT and brain CT or MRI is performed within 42 days and 56 days, respectively, before initiation of brigatinib (for both CT and MRI, contrast-enhanced scans are preferable) (Images performed before initiation of prior treatment are not acceptable even if they are performed within 42 days before initiation of brigatinib.)
5) Age 20 years or older at the time of informed consent.
6) Patients who have been fully informed of the content of this clinical study and personally provided voluntary written informed consent
Key exclusion criteria
Patients for whom the attending physician judged that participation in this clinical study is inappropriate
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Yamamoto |
Organization
Wakayama Medical University
Division name
Internal Medicine III
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture
TEL
073-447-2300
nbyamamoto@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka, JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture
Tel
073-441-0896
wa-rinri@wakayama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we will conduct plasma-based ctDNA analysis, serum cytokine analysis, tissue gene expression analysis, and tissue DNA analysis in order to examine the predictors of the therapeutic effect of brigatinib. Quality of life assessment using ePRO will also be conducted.
Management information
Registered date
| 2020 | Year | 11 | Month | 13 | Day |
Last modified on
| 2023 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048172
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