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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042439
Receipt No. R000048172
Scientific Title For ALK-rearranged advanced NSCLC, Brigatinib as 2nd or 3rd line after Alectinib in 1st line: as 2nd or 3rd line: Prospective Multi-institutional Observational Study: (ABRAID Study) (WJOG11919L)
Date of disclosure of the study information 2020/11/13
Last modified on 2020/11/13

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Basic information
Public title For ALK-rearranged advanced NSCLC, Brigatinib as 2nd or 3rd line after Alectinib in 1st line: as 2nd or 3rd line: Prospective Multi-institutional Observational Study: (ABRAID Study) (WJOG11919L)
Acronym For ALK-rearranged advanced NSCLC, Brigatinib as 2nd or 3rd line after Alectinib in 1st line (ABRAID Study) (WJOG11919L)
Scientific Title For ALK-rearranged advanced NSCLC, Brigatinib as 2nd or 3rd line after Alectinib in 1st line: as 2nd or 3rd line: Prospective Multi-institutional Observational Study: (ABRAID Study) (WJOG11919L)
Scientific Title:Acronym For ALK-rearranged advanced NSCLC, Brigatinib as 2nd or 3rd line after Alectinib in 1st line (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:
1. Alectinib alone (i.e., Patients planned to receive brigatinib as second-line treatment) (Cohort A)
2. Alectinib followed by cytotoxic anticancer medication (single agent or combined, with or without concomitant immune-checkpoint inhibitor) or lorlatinib (i.e., Patients planned to receive brigatinib as third-line treatment) (Cohort B)
Note: In patients with recurrence >=6 months after last dosing of preoperative/postoperative adjuvant chemotherapy, the therapy is not included in the history of prior treatment.
3) Patients planned to receive brigatinib monotherapy in clinical practice according to the current package insert for brigatinib
4) Patients in whom evaluation by chest CT and brain CT or MRI is performed within 28 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 28 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 150

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
Email 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
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2021 Year 03 Month 01 Day
Last follow-up date
2025 Year 02 Month 28 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
2020 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048172

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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