UMIN-CTR Clinical Trial

Basic information
Public title	Observational biomarker study related to the resistance mechanism of 3rd generation EGFR-TKI (osimertinib)(LOGIK1607)
Acronym	Observational biomarker study related to the resistance mechanism of osimertinib (LOGIK1607)
Scientific Title	Observational biomarker study related to the resistance mechanism of 3rd generation EGFR-TKI (osimertinib)(LOGIK1607)
Scientific Title:Acronym	Observational biomarker study related to the resistance mechanism of osimertinib (LOGIK1607)
Region	Japan

Condition
Condition	EGFR mutation positive and T790M positive non-small cell lung cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	We investigate known or novel factors regarding 3rd generation EGFR-TKI (osimertinib) acquired resistance (AR) mechanisms in EGFR mutation positive lung cancer and analyze the correlation between the factors and the clinicopathological data as biomarker research of osimertinib AR.
Basic objectives2	Others
Basic objectives -Others	Gene analysis, protein expression analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gene analysis using next generation sequencing and protein expression analysis using immunohistochemistry
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	1. Paraffin embedded specimen The specimen collected from a lesion at the confirmation of progression disease after osimertinib treatment is submitted with the specimen before osimertinib treatment. 2. Blood sample Blood sample is collected after PD confirmation. Gene analysis: DNA and RNA are extracted from formalin-fixed paraffin-embedded (FFPE) tissue slice and a detection of somatic gene mutation is performed using next generation sequencer, ionPGM. The somatic mutation, copy number variants and fusion drivers of 143 genes of interest are measured using Oncomine Cancer Research Panel (OCP, Thermo Fisher Scientific Inc.). cfDNA analysis: cfDNA is extracted from plasma and the somatic gene mutation, copy number variants are measured using a custom panel on ionPGM platform. Protein expression analysis: The quantitative or qualitative measurement of protein related to immune checkpoints (such as PD-L1/ PD-1, Foxp3) is performed using immunohistochemical staining of FFPE.
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	Primary enrollment: The eligible patients are lung cancer patients whose formalin-fixed paraffin-embedded biopsy samples before osimertinib treatment are proven to have EGFR T790M mutation and who are planned to receive or receiving osimertinib treatment. The pre-treatment sample have to meet the "species and quantity of the sample" criteria. Secondary enrollment: Patients whose tumor tissue samples are available at the confirmation of progression disease after durable response to osimertinib treatment (documented PR/CR or SD for more than 6 months determined by RECIST or WHO criteria) and who are not started other anti-tumor treatment (chemotherapy, radiotherapy, immunotherapy) are eligible. Patients with adhesion therapy by minomycin, OK-432 and talc for coelomic fluid retention are also eligible. The sample have to meet the "species and quantity of the sample" criteria.
Key exclusion criteria	Patients who receive osimertinib concurrently with other cytotoxic agents, molecular targeting agents or immune-checkpoint inhibitors are excluded. Patients whose tumor specimens cannot meet the eligibility criteria or the "paired" specimens (pre and post osimertinib treatment) cannot be submitted are also excluded.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kenji Sugio
Organization	Oita University Faculty of Medicine
Division name	Department of Thoracic and Breast Surgery
Zip code
Address	1-1 Idaigaoka, Hasama-machi, Yufu, Oita 879-5593, Japan
TEL	097-586-5854
Email	ksugio@oita-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Atsushi Osoegawa
Organization	Oita University Faculty of Medicine
Division name	Department of Thoracic and Breast Surgery
Zip code
Address	1-1 Idaigaoka, Hasama-machi, Yufu, Oita 879-5593, Japan
TEL	097-586-5854
Homepage URL
Email	osoegawa-ths@oita-u.ac.jp

Sponsor
Institute	Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	Astra Zenaca
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	2016 Year 12 Month 15 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	Main results already published
Date of protocol fixation	2016 Year 10 Month 19 Day
Date of IRB	2016 Year 12 Month 01 Day
Anticipated trial start date	2017 Year 02 Month 28 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

Other
Other related information

Management information
Registered date	2016 Year 12 Month 15 Day
Last modified on	2021 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029086