UMIN-CTR Clinical Trial

Basic information
Public title	An obsevational study of EGFR mutation status by circulating tumor DNA and tissue during the osimertinib treatment in poor PS patients with T790M positive advanced NSCLC
Acronym	An observational study of EGFR muta tion status during the osimertinib treatment in poor PS patients
Scientific Title	An obsevational study of EGFR mutation status by circulating tumor DNA and tissue during the osimertinib treatment in poor PS patients with T790M positive advanced NSCLC
Scientific Title:Acronym	An observational study of EGFR muta tion status during the osimertinib treatment in poor PS patients
Region	Japan

Condition
Condition	non small cell lung cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clear the resistant mechanism of o simertinib treatment for lung cancer h arboring EGFR activating and T790M mutations by periodical analysis of EG FR mutations (activating, T790M, and C797S) in circulating tumor DNA and tissue using an improved PNA-LNA PCR clamp method.
Basic objectives2	Others
Basic objectives -Others	To evaluate the percentage of the cas es emerging C797S mutation in all os eimertinib resistant patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The occurrence ratio of plasma C797 S mutations in all osimertinib resistant cases
Key secondary outcomes	Comparison of the therapeutic effect by the presence of C797S appearance at the time of all osimertinib resistant cases

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.The case registered with NEJ032B study 2.Written informed consent
Key exclusion criteria	An inappropriate case judged by doctor in charge
Target sample size	32

Research contact person
Name of lead principal investigator	1st name Middle name Last name Makoto Maemondo
Organization	Miyagi Cancer center
Division name	Department of respiratory medicine
Zip code
Address	47-1 Nodayama, Medeshima-Shiote,Natori,Miyagi
TEL	022-384-3151
Email	maemondo-ma693@miyagi-pho.jp

Public contact
Name of contact person	1st name Middle name Last name Kana Watanabe
Organization	Miyagi Cancer center
Division name	Department of respiratory medicine
Zip code
Address	47-1 Nodayama, Medeshima-Shiote,Natori,Miyagi
TEL	022-384-3151
Homepage URL
Email	watanabe-ka750@miyagi-pho.jp

Sponsor
Institute	North East Japan Study Group (NEJSG)
Institute
Department

Funding Source
Organization	North East Japan Study Group (NEJSG)
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Molecular Genetic Research Departm ent, LSI Medience Corporation.
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 01 Month 18 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	Completed
Date of protocol fixation	2017 Year 01 Month 16 Day
Date of IRB	2016 Year 12 Month 15 Day
Anticipated trial start date	2017 Year 01 Month 18 Day
Last follow-up date	2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study was research accompanied with NEJ032B study. The results will be presented after presenation of rasult from NEJ032B. The results of this study was accepted to publish in JJCO in 2021.

Management information
Registered date	2017 Year 01 Month 17 Day
Last modified on	2021 Year 09 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029592