UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056986 |
|---|---|
| Receipt number | R000065124 |
| Scientific Title | HER2 Aberrations in EGFR Mutation-Positive Lung Cancer:Clinical Landscape, EGFR-TKI Efficacy, and Prognostic Impact(HERITAGE study) |
| Date of disclosure of the study information | 2025/02/10 |
| Last modified on | 2025/02/10 11:41:02 |
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Basic information
Public title
HER2 Aberrations in EGFR Mutation-Positive Lung Cancer:Clinical Landscape, EGFR-TKI Efficacy, and Prognostic Impact(HERITAGE study)
Acronym
HERITAGE study
Scientific Title
HER2 Aberrations in EGFR Mutation-Positive Lung Cancer:Clinical Landscape, EGFR-TKI Efficacy, and Prognostic Impact(HERITAGE study)
Scientific Title:Acronym
HERITAGE study
Region
| Japan |
Condition
Condition
Non-Small Cell Lung Cancer Harbouring EGFR mutation
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To determine the HER2 protein overexpression frequency and the impact of HER2 aberrations on the response to EGFR-TKIs and prognosis in patients with EGFR mutation-positive lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
HER2 amplification/expression rate in patients with EGFR mutation-positive lung cancer
Progression-free survival (PFS) by HER2 expression level
Key secondary outcomes
Time to treatment failure (TTF), objective response rate (ORR), and overall survival (OS) by HER2 expression level
HER2 protein overexpression frequency
Concordance rate between HER2 IHC and FISH
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
Patients who are evaluable for HER2 aberrations using formalin-fixed paraffin-embedded (FFPE) tumor specimens collected before EGFR-TKI therapy, from among all patients enrolled in OSI-FACT study.
Key exclusion criteria
Patients considered inappropriate by the treating physician for any reason, such as inability to collect information required for CRF completion.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Eisaku |
| Middle name | |
| Last name | Miyauchi |
Organization
Tohoku University Hospital
Division name
Department of Respiratory Medicine
Zip code
980-8574
Address
1-1, Seiryo-machi, Aobaku, Sendai, Miyagi
TEL
0227178539
eisaku.miyauchi.b5@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Tatsunori |
| Middle name | |
| Last name | Ito |
Organization
HOPE
Division name
HOPE
Zip code
9818574
Address
1-1, Seiryo-machi, Aobaku, Sendai, Miyagi
TEL
022-717-8539
Homepage URL
tatsunori.ito.b1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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, Graduate School of Medicine, Tohoku University
Address
2-1, Seiryo-machi, Aobaku, Sendai, Miyagi
Tel
0227177146
ec@rinri.hosp.tohoku.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 | 02 | Month | 10 | 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 | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A multicenter, retrospective, observational study
Management information
Registered date
| 2025 | Year | 02 | Month | 10 | Day |
Last modified on
| 2025 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065124
