UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000029017
Receipt No. 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 (Ver. 7)

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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
Email 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
Email tkm-ymur@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032685