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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033993
Receipt No. R000038757
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
Date of disclosure of the study information 2018/09/05
Last modified on 2018/09/11

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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
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)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
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 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
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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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