UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029017 |
|---|---|
| Receipt number | R000032685 |
| Scientific Title | The EGFR C797S mutation in TKI-naive NSCLC |
| Date of disclosure of the study information | 2017/09/05 |
| Last modified on | 2020/09/17 23:49:25 |
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Basic information
Public title
The EGFR C797S mutation in TKI-naive NSCLC
Acronym
de novo EGFR C797S mutation in NSCLC
Scientific Title
The EGFR C797S mutation in TKI-naive NSCLC
Scientific Title:Acronym
de novo EGFR C797S mutation in NSCLC
Region
| Japan |
Condition
Condition
Non small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Prediction of treatment efficacy of third generation TKI against first line EGFR-TKI resistant NSCLC through the examination of de novo EGFR C797S mutation in known EGFR mutant NSCLC,
Basic objectives2
Others
Basic objectives -Others
Frequency of gene expression
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of EGFR-C797S mutation in EGFR TKI naive NSCLC
Key secondary outcomes
EGFR-T790M mutation, allelic pattern of T790M and C797S mutation, clinicopathological features, HER2 amplification, and MET amplification
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) Patients who was undergone lung resection or tumor biopsy at Fukushima Medical University Hospital between January 207 and December 2015.
2) Pathologically confirmation of primary non small cell lung cancer
3)EGFR mutation had been examined, and confirmed as follows; G719 mutation, Exon 19 deletion, S768I mutation, T790M mutation, L858R mutation, or L861Q mutation
4) Written informed consent
Key exclusion criteria
EGFR-TKI administration before specimen collection
Target sample size
244
Research contact person
Name of lead principal investigator
| 1st name | HIroyuki |
| Middle name | |
| Last name | Suzuki |
Organization
Fukushima Medical University
Division name
Department of Chest Surgery
Zip code
960-1295
Address
1, Hikarigaoka, Fukushima, 960-1295, Japan
TEL
(+81)24-547-1252
hiro@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Yamaura |
Organization
Fukushima Medical University
Division name
Department of Chest Surgery
Zip code
960-1295
Address
1, Hikarigaoka, Fukushima, 960-1295, Japan
TEL
(+81)24-547-1252
Homepage URL
tkm-ymur@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca, K.K.
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
Fukushima Medical University Research Ethics Committee
Address
Hikarigaoka-1 Fukushima 960-1295,Japan
Tel
024-547-1825
rs@fmu.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
| 2017 | Year | 09 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.spandidos-publications.com/10.3892/ol.2020.11524
Publication of results
Published
Result
URL related to results and publications
https://www.spandidos-publications.com/10.3892/ol.2020.11524
Number of participants that the trial has enrolled
248
Results
No concurrent C797S mutation with known EGFR gene mutation was identified. T790M mutation was identified in 12 patients (4.9%). ERBB2 or MET gene amplification was found in a few patients (0.0-0.4%). MDM2 gene amplification was associated with tumor recurrence and shorter progression free survival for first or second generation EGFR-TKIs.
Results date posted
| 2020 | Year | 09 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Consecutive patients who underwent initial lung resection or surgical tumor biopsy in Fukushima Medical University Hospital between January 2007 and December 2015, and were diagnosed with NSCLC harboring a known EGFR gene activating mutation (e.g., exon 19 deletion, L858R, T790M, S768I, G719X and L861Q) at the time samples were collected.
Participant flow
All cases satisfying the above were incorporated with written consent.
Adverse events
Not applicable
Outcome measures
Clinicopathological parameters, presence of EGFR C797S and T790M mutations. and gene amplifications(ERBB2, MET, EGFR, ALK, BRAF, FGFR1, MYC, RET, CCND1, CCND2, CDK4, CDK6, MDM2 and MDM4)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 29 | Day |
Other
Other related information
To clarify the frequency of EGFR C797S mutation in EGFR-TKI naive NSCLC surgical specimen using an improved PNA-LNA PCR clamp method, and allelic pattern analysis of T790M and C797S mutation is performed(Sanger's method). Sensitivity and resistance against EGFR-TKI was analyzed through comparison between EGFR T790M mutation(PNA-LNA clamp method), HER2 amplification, and MET amplification (quantitive PCR method) and clinicopathological features.
Management information
Registered date
| 2017 | Year | 09 | Month | 05 | Day |
Last modified on
| 2020 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032685
