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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041251
Receipt No. R000047106
Scientific Title Retrospective observational study of osimertinib and afatinib for patients with advanced EGFR-mutated non-small cell lung cancer.
Date of disclosure of the study information 2020/07/30
Last modified on 2020/07/29

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Basic information
Public title Retrospective observational study of osimertinib and afatinib for patients with advanced EGFR-mutated non-small cell lung cancer.
Acronym Retrospective study of osimertinib and afatinib in EGFR-mutated NSCLC.
Scientific Title Retrospective observational study of osimertinib and afatinib for patients with advanced EGFR-mutated non-small cell lung cancer.
Scientific Title:Acronym Retrospective study of osimertinib and afatinib in EGFR-mutated NSCLC.
Region
Japan

Condition
Condition Advanced non-small cell lung cancer harboring EGFR mutation.
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of osimertinib and afatinib for advanced non-small cell lung cancer harboring EGFR mutation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to Discontinuation of any EGFR tyrosine kinase inhibitor (TD-TKI)
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. Diagnosed pathologically with non-small cell lung cancer.
2. With EGFR mutation, regardless of subtype of mutation.
3. Recieved afatinib or osimertinib as systemic first-line monotherapy.
Key exclusion criteria 1. Not recieved afatinib or osimertinib as a monotherapy.
2. Recieved chemotherapy or immunotherapy before monotherapy of afatinib/osimertinib as systemic treatment for advanced non-small cell lung cancer.
3. Cases identified as ineligible by investigator.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Morise
Organization Nagoya University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code 466-8560
Address 65, Turumaicho, Showaku, Nagoya, Aichi, Japan
TEL +81-052-741-2111
Email morisem@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Kentaro
Middle name
Last name Ito
Organization Matsusaka Municipal Hospital
Division name Department of Respiratory Medicine, Respiratory Center
Zip code 515-0073
Address 1550, Tonomachi, Matsusaka City, Mie, Japan
TEL +81-598-23-1515
Homepage URL
Email kentarou_i_0214@yahoo.co.jp

Sponsor
Institute Central Japan Lung Study Group (CJLSG)
Institute
Department

Funding Source
Organization Central Japan Lung Study Group (CJLSG)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Matsusaka Municipal Hospital
Address 1550, Tonomachi, Matsusaka, Mie, Japan
Tel +81-598-23-1515
Email kentarou_i_0214@yahoo.co.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

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 30 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 557
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 No longer recruiting
Date of protocol fixation
2019 Year 11 Month 12 Day
Date of IRB
2019 Year 12 Month 16 Day
Anticipated trial start date
2020 Year 02 Month 20 Day
Last follow-up date
2020 Year 07 Month 31 Day
Date of closure to data entry
2020 Year 07 Month 31 Day
Date trial data considered complete
2020 Year 08 Month 14 Day
Date analysis concluded
2021 Year 01 Month 31 Day

Other
Other related information Study design: Multicenter, retrospective observational cohort study
Data cut-off in survival analysis: 31 Dec 2019 in the survival analysis.
Revision History of the study protocol:
2019.11.12 version 1.0
2020. 1.13 version 1.1
2020. 1.20 version 1.2
2020. 3.18 version 1.3


*The case enrollment period was extended to July 31, 2020, by the memorandum after version 1.3 of the protocol.

Management information
Registered date
2020 Year 07 Month 29 Day
Last modified on
2020 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047106

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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