UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044738 |
|---|---|
| Receipt number | R000051095 |
| Scientific Title | Biomarker analysis of WJOG6410L/IMPACT: A randomized phase III trial of adjuvant gefitinib versus cisplatin and vinorelbine in completely resected (Stage II-III) non-small cell lung cancer patients with EGFR mutation |
| Date of disclosure of the study information | 2021/07/02 |
| Last modified on | 2023/07/04 12:13:42 |
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Basic information
Public title
Biomarker analysis of WJOG6410L/IMPACT: A randomized phase III trial of adjuvant gefitinib versus cisplatin and vinorelbine in completely resected (Stage II-III) non-small cell lung cancer patients with EGFR mutation
Acronym
Biomarker analysis of WJOG6410L/IMPACT
Scientific Title
Biomarker analysis of WJOG6410L/IMPACT: A randomized phase III trial of adjuvant gefitinib versus cisplatin and vinorelbine in completely resected (Stage II-III) non-small cell lung cancer patients with EGFR mutation
Scientific Title:Acronym
WJOG6410LTR
Region
| Japan |
Condition
Condition
Completely resected (Stage II-III)
non-small cell lung cancer patients with EGFR mutation
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objectives of this study are to clarify the markers which predict the efficacy of EGFR-TKI in completely resected NSCLC patients with EGFR mutation, and to clarify the markers which predict the risk of postoperative recurrence in completely resected NSCLC patients with EGFR mutation
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To clarify the markers which predict the efficacy of EGFR-TKI in completely resected NSCLC patients with EGFR mutation
Key secondary outcomes
To clarify the markers which predict the risk of postoperative recurrence in completely resected NSCLC patients with EGFR mutation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Enrolled in WJOG6410L/IMPACT study
2) Submittable FFPE specimens from surgically resected tumor
3) Consented to participate in this study
Key exclusion criteria
Not applicable
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Tsuboi |
Organization
National Cancer Center Hospital East
Division name
Division of Thoracic Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
mtsuboi@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | Ikeda |
| Last name | Ikeda |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Respiratory Medicine / Clinical Research Center
Zip code
236-0051
Address
Yokohama
TEL
0457019581
Homepage URL
isatoshi0112@gmail.com
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
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 Review Committee, National Cancer Center
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
Tel
04-7133-1111
isatoshi0112@gmail.com
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
国立がん研究センター東病院（千葉県）
神奈川県立循環器呼吸器病センター（神奈川県）
和歌山県立医科大学（和歌山県）
仙台厚生病院（宮城県）
千葉大学医学部附属病院（千葉県）
東京医科大学病院（東京都）
神奈川県立がんセンター（神奈川県）
静岡県立静岡がんセンター（静岡県）
聖隷三方原病院（静岡県）
名古屋大学医学部附属病院（愛知県）
愛知県がんセンター（愛知県）
名古屋医療センター（愛知県）
金沢大学附属病院（石川県）
大阪市立総合医療センター（大阪府）
近畿大学病院（大阪府）
近畿中央呼吸器センター（大阪府）
大阪国際がんセンター（旧 大阪府立成人病センター）（大阪府）
大阪市立大学医学部附属病院（大阪府）
倉敷中央病院（岡山県）
岡山大学病院（岡山県）
広島大学病院（広島県）
広島市立広島市民病院（広島県）
山口宇部医療センター（山口県）
九州がんセンター（福岡県）
がん研究会有明病院（東京都）
順天堂大学医学部附属順天堂医院（東京都）
四国がんセンター（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 02 | Day |
Related information
URL releasing protocol
https://meetings.asco.org/abstracts-presentations/223104
Publication of results
Partially published
Result
URL related to results and publications
https://meetings.asco.org/abstracts-presentations/223104
Number of participants that the trial has enrolled
211
Results
Multivariate analysis showed that NOTCH1 co-mutation was a significant poor prognostic factor for OS in the gefitinib group and CREBBP co-mutation for DFS and OS in the cis/vin group.
In patients with NOTCH1 co-mutations, OS was shorter in the gefitinib group, with a significant interaction (P for interaction=0.039).
In patients with CREBBP co-mutations, DFS was longer in the gefitinib group, with a significant interaction (P for interaction=0.058).
Results date posted
| 2023 | Year | 07 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Frequent co-existing somatic mutation included TP53 (58.4%), CUB and Sushi Multiple Domain 3 (11.8%), and NOTCH1 (9.9%).
Participant flow
Of 234 patients enrolled in the IMPACT study, we were able to analyze 202 patients (86%).
Adverse events
Not applicable
Outcome measures
This IMPACT-TR study was an exploratory biomarker study of the IMPACT study. Resected lung cancer specimens were analyzed for 409 cancer-related gene mutations, tumor mutation burden and whole-genome copy number alterations. We matched these data to DFS and overall survival (OS) to search for predictors of survival.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
In this study, we will use postoperative specimens, so a certain amount of DNA and RNA damage is expected. Therefore, in the Feasibility part, we will first confirm the feasibility of the measurement in about 30 cases at 3 institutions. If the data can be evaluated, we will consider it a success, and we will evaluate the sequencing and run data. The sequencing and Oncoscan run data will be evaluated based on quality control indicators.
Of the 234 patients in the main study, we will enroll as many patients as possible who meet the selection criteria, and aim to measure 200 patients in total, including 30 patients in the Feasibility part.
Management information
Registered date
| 2021 | Year | 07 | Month | 02 | Day |
Last modified on
| 2023 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051095
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