UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059178 |
|---|---|
| Receipt number | R000066622 |
| Scientific Title | A multicenter retrospective observational study of real-world T-DXd treatment for stage4 HER2-mutated non-small cell lung cancer patients in Japan (REAL-HER2 Study) (WJOG21224L) |
| Date of disclosure of the study information | 2025/09/25 |
| Last modified on | 2025/09/24 16:55:14 |
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Basic information
Public title
A multicenter retrospective observational study of real-world T-DXd treatment for stage4 HER2-mutated non-small cell lung cancer patients in Japan (REAL-HER2 Study) (WJOG21224L)
Acronym
REAL-HER2 Study
Scientific Title
A multicenter retrospective observational study of real-world T-DXd treatment for stage4 HER2-mutated non-small cell lung cancer patients in Japan (REAL-HER2 Study) (WJOG21224L)
Scientific Title:Acronym
REAL-HER2 Study
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate real-world treatment patterns in previously treated patients with stage IV HER2-mutant non-small cell lung cancer (NSCLC) in Japan, and to assess the effectiveness and safety of trastuzumab deruxtecan (T-DXd) in routine clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rwPFS (real-world Progression Free Survival)
Key secondary outcomes
1) OS (Overall Survival)
2) TTF (Time to treatment failure)
3) rwORR (Real-world objective response rate)
4) rwDCR (Real-world disease control rate)
5) Treatment duration
6) Adverse Event
7) Analysis of prognostic factors
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients aged >_18 years at the time of first administration of T-DXd.
2.Patients diagnosed with stage IV HER2-mutant non-small cell lung cancer (NSCLC) by February 28, 2025.
3.Patients who received their first dose of T-DXd between August 23, 2023, and February 28, 2025.
4.Patients who received T-DXd as second-line or later therapy for stage IV HER2-mutant NSCLC.
Note: Patients with recurrence after definitive therapy (surgery, definitive chemoradiotherapy, or definitive radiotherapy) are excluded.
Key exclusion criteria
1.Patients who declined to participate in the study.
2.Patients deemed inappropriate for inclusion based on the investigator's judgment.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Hayashi |
Organization
Kindai University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-Sayama, Osaka
TEL
072-366-0221
hidet31@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ishizuka |
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 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
https://www.wjog.jp/
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO CO., LTD.
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
Ethics Committee, Faculty of Medicine, Kinki University
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka
Tel
072-366-0221
zizen@med.kindai.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
| 2025 | Year | 09 | Month | 25 | 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
| 2025 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2027 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter retrospective cohort study
Management information
Registered date
| 2025 | Year | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066622
