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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034321
Receipt No. R000039126
Scientific Title A retrospective study of interstitial lung disease due to EGFR tyrosine kinase inhibitor and immune checkpoint inhibitor
Date of disclosure of the study information 2018/10/01
Last modified on 2018/09/29

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Basic information
Public title A retrospective study of interstitial lung disease due to EGFR tyrosine kinase inhibitor and immune checkpoint inhibitor
Acronym NEJ040
Scientific Title A retrospective study of interstitial lung disease due to EGFR tyrosine kinase inhibitor and immune checkpoint inhibitor
Scientific Title:Acronym NEJ040
Region
Japan

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

Objectives
Narrative objectives1 To evaluate reasonable sequence and interval to use EGFR tyrosine kinase inhibitor and immune checkpoint inhibitor for patients with non-small cell lung cancer harboring EGFR mutation
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationships between sequence/interval to use EGFR tyrosine kinase inhibitor and immune checkpoint inhibitor, and frequency/severity of interstitial lung disease
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.non-small cell lung cancer with EGFR mutations
2.To have treatment history using EGFR tyrosine kinase inhibitor and immune check poinnt inhibitor
Key exclusion criteria non
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhisa Takahashi
Organization Juntendo University
Division name Department of Respiratory Medicine
Zip code
Address Hongo 2-1-1, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email kztakaha@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Ko
Organization Juntendo University
Division name Department of Respiratory Medicine
Zip code
Address Hongo 2-1-1, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email rkou@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 10 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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Survey Components

Patient characteristics, information of survival, information of treatment, information of interstitial lung disease

Management information
Registered date
2018 Year 09 Month 29 Day
Last modified on
2018 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039126

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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