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Recruitment status
Unique ID issued by UMIN UMIN000027233
Receipt No. R000031202
Scientific Title A prospective observational study of osimertinib as predictive marker against patients with EGFR T790M-positive NSCLC.
Date of disclosure of the study information 2017/05/06
Last modified on 2017/05/03

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Basic information
Public title A prospective observational study of osimertinib as predictive marker against patients with EGFR T790M-positive NSCLC.
Acronym Osimertinib as predictive marker in T790M-positive NSCLC
Scientific Title A prospective observational study of osimertinib as predictive marker against patients with EGFR T790M-positive NSCLC.
Scientific Title:Acronym Osimertinib as predictive marker in T790M-positive NSCLC
Region
Japan

Condition
Condition Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To predict the efficacy and therapeutic resistance of Osimertinib by the quantitative amount of T790M and C797S.
To explore the possibility of PIK3CA, BRAF, beta-catenin, MET and HER2 as a chemoresistant marker of Osimertinib
using blood and biopsy sample.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary endpoint:To predict the efficacy of osimertinib according to quantitative amount of T790M expression.
Secandary endpoint:To predict the efficacy of osimertinib according to quantitative amount of C797S.
Key secondary outcomes

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 1) Pathologically confirmation of non small cell lung cancer
2) EGFR gene mutation with T790M has been examined
3) Administration of osimertinib is planned or ongoing
4) Aged 20 or more
5) Expected survival over 12 weeks
6) Adequate organ functions
7) Written informed consent
Key exclusion criteria 1)Active double cancer
2)Interstitial pneumonitis on chest CT
3)Symptomatic brain metastases
4)Uncontrollable pleural effusion or pericardial effusion
5)Active infectious disease
6)No allogeneic bone marrow transplant
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyoichi Kaira
Organization Gunma University Hospital
Division name Innovative Medical Center
Zip code
Address 3-39-15, Showa-machi, Maebashi, Gunma, Japan
TEL 027-220-8222
Email kkaira1970@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kyoichi Kaira
Organization Gunma University Hospital
Division name Innovative Medical Center
Zip code
Address 3-39-15, Showa-machi, Maebashi, Gunma, Japan
TEL 027-220-8222
Homepage URL
Email kkaira1970@yahoo.co.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization AstraZeneca company
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
Address
Tel
Email

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 05 Month 06 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
Date of protocol fixation
2017 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Approximately 20 mL of blood samples will be collected at the following three time points: before treatment with
osimertinib, at one month of treatment, and at the time of recurrence. The number of copies of T790M, C797S, and
sensitive mutations (Del19 or L858R) in these blood samples will be determined using a digital PCR system (Bio-Rad
Laboratories, Inc.) for a quantitative assessment. Changes in the quantified number of copies of T790M and C797S after
the start of treatment with osimertinib will be assessed in terms of response rate and survival time (progression-free
survival and overall survival) for an exploratory investigation of the potential of these mutations as treatment predictive
biomarkers.
Moreover, the effect of the number of copies of T790M before treatment on prognosis after treatment, i.e., the role of the
number of copies of T790M as a prognostic factor, will be assessed, and any relationship between percent reductions in
the number of copies themselves and the therapeutic effect of osimertinib will be clarified. As factors affecting this
therapeutic effect, the expression levels of PIK3CA, BRAF, EMT, MET, and HER2, possible causative factors for the
resistance to first- and second-generation EGFR TKIs, will be assessed through analysis of gene mutations and
amplifications in DNA samples extracted from re-biopsy tumor specimens before treatment, to determine a correlation
between the therapeutic effect of osimertinib and the number of copies of the T790M, C797S, and sensitive mutations,
and other relationships.

Management information
Registered date
2017 Year 05 Month 03 Day
Last modified on
2017 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031202

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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