UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective study to investigate PD-L1 expression before and after EGFR-TKI therapy and its relationship with EGFR-TKI resistance mechanism in EGFR mutation-positive advanced recurrent non- squamous non-small-cell lung cancer
Acronym	A retrospective study to investigate PD-L1 expression before and after EGFR-TKI therapy and its relationship with EGFR-TKI resistance mechanism in EGFR mutation-positive advanced recurrent non- squamous non-small-cell lung cancer
Scientific Title	A retrospective study to investigate PD-L1 expression before and after EGFR-TKI therapy and its relationship with EGFR-TKI resistance mechanism in EGFR mutation-positive advanced recurrent non- squamous non-small-cell lung cancer
Scientific Title:Acronym	A retrospective study to investigate PD-L1 expression before and after EGFR-TKI therapy and its relationship with EGFR-TKI resistance mechanism in EGFR mutation-positive advanced recurrent non- squamous non-small-cell lung cancer
Region	Japan

Condition
Condition	EGFR mutation-positive advanced recurrent non-squamous non-small-cell lung cancer
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate changes in tumor immune microenvironment between before and after EGFR-TKI therapy by immunostaining in patients with EGFR mutation-positive advanced recurrent non-squamous non-small-cell lung cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The changes in PD-L1 expression level, CD73, TILs, and nonsynonymous mutation burden before and after EGFR-TKIs treatment
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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Purpose of intervention
Type of intervention
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Interventions/Control_2
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Aged 20 years or older 2)Patients with pathologically confirmed non-squamous non-small-cell lung cancer 3)Patients at stage IIIB/IV (including those who had recurrence after definitive treatment such as surgery or radiotherapy) 4)Patients with confirmed EGFR mutation (any variant type) 5)Patients who were treated at Department of Medical Oncology, Kinki University Faculty of Medicine or a joint study institution 6)Patients whose tumor tissue at baseline available for this study 7)Patients who were confirmed to have disease progression during EGFR-TKI treatment and whose tumor tissues have been obtained at subsequent biopsy 8)As for the patients who received Osimertinib, T790M mutation must be detected during the previous conventional EGFR-TKIs
Key exclusion criteria	Not established
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hidetoshi Hayashi
Organization	Kindai University, Faculty of Medicine
Division name	Department of Medical Oncology
Zip code
Address	377-2 Ohno-higashi, Osaka-Sayama, 589-8511, Japan
TEL	072-366-0221
Email	hidet31@med.kindai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Koji Haratani
Organization	Kindai University, Faculty of Medicine
Division name	Department of Medical Oncology
Zip code
Address	377-2 Ohno-higashi, Osaka-Sayama, 589-8511, Japan
TEL	072-366-0221
Homepage URL
Email	haratani_k@med.kindai.ac.jp

Sponsor
Institute	Kindai university, Faculty of Medicine, Department of Medical Oncology
Institute
Department

Funding Source
Organization	AstraZeneca K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
Organization
Address
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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	近畿大学 神奈川県立循環器呼吸器病センター 倉敷中央病院 岸和田市民病院

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 05 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	Enrolling by invitation
Date of protocol fixation	2017 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date	2017 Year 11 Month 30 Day
Last follow-up date
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Date trial data considered complete
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Other

Other related information

We will evaluate changes in tumor immune microenvironment, including PD-L1, CD73, TILs, and tumor mutation burden in the tumor tissues between before and after EGFR-TKI therapy by immunostaining and whole-exome sequencing in patients with EGFR mutation-positive advanced recurrent non-squamous non-small-cell lung cancer at Department of Medical Oncology, Kinki University Faculty of Medicine or a joint study institution.

Management information
Registered date	2018 Year 09 Month 02 Day
Last modified on	2018 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038757

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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