UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of immune status in non-small cell lung cancer patients with EGFR mutations
Acronym	Analysis of immune status in NSCLC with EGFR mutations
Scientific Title	Analysis of immune status in non-small cell lung cancer patients with EGFR mutations
Scientific Title:Acronym	Analysis of immune status in NSCLC with EGFR mutations
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology Chest surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To elucidate immune status of non-small cell lung cancer patients with EGFR mutations who receive EGFR-TKIs
Basic objectives2	Others
Basic objectives -Others	Search for biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of immune cells in tumor-infiltrating lymphocytes from pre- to post-treatment with EGFR-TKIs.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All patients with advanced EGFR-mutated NSCLC receiving EGFR-TKIs as 1st line treatment whose tumor samples pre- and post-treatment are surplus will be enrolled in this study. Patients who already treated EGFR-TKI with archive samples will be also enrolled in this study.
Key exclusion criteria	Patients who are not feasible for biopsy will be excluded.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hiroyoshi Middle name Last name Nishikawa
Organization	National Cancer Center
Division name	Division of Cancer Immunology
Zip code	277-8577
Address	6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL	0471331111
Email	hnishika@ncc.go.jp

Public contact
Name of contact person	1st name Yosuke Middle name Last name Togashi
Organization	National Cancer Center
Division name	Division of Cancer Immunology
Zip code	277-8577
Address	6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL	0471331111
Homepage URL
Email	ytogashi1584@gmail.com

Sponsor
Institute	National Cancer Center
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	National Cancer Center
Address	6-5-1 Kashiwanoha
Tel	0471331111
Email	irst@ml.res.ncc.go.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	国立がん研究センター東病院

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 01 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	Terminated
Date of protocol fixation	2018 Year 02 Month 01 Day
Date of IRB	2018 Year 01 Month 16 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Immune status of tumor microenvironment is analyzed.

Management information
Registered date	2018 Year 01 Month 31 Day
Last modified on	2019 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035487