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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016916
Receipt No. R000019634
Scientific Title Multicenter, retrospective, and observational study of afatinib treatment in patients with non-small cell lung cancer harboring EGFR mutation who previously treated with EGFR-TKI.
Date of disclosure of the study information 2015/03/26
Last modified on 2015/09/28

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Basic information
Public title Multicenter, retrospective, and observational study of afatinib treatment in patients with non-small cell lung cancer harboring EGFR mutation who previously treated with EGFR-TKI.
Acronym Multicenter, retrospective, and observational study of afatinib treatment in patients with non-small cell lung cancer harboring EGFR mutation who previously treated with EGFR-TKI.
Scientific Title Multicenter, retrospective, and observational study of afatinib treatment in patients with non-small cell lung cancer harboring EGFR mutation who previously treated with EGFR-TKI.
Scientific Title:Acronym Multicenter, retrospective, and observational study of afatinib treatment in patients with non-small cell lung cancer harboring EGFR mutation who previously treated with EGFR-TKI.
Region
Japan

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

Objectives
Narrative objectives1 to analyse safety and efficacy of afatinib therapy in patients with non-small cell lung cancer harboring EGFR mutation who previously treated with EGFR-TKI
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safty
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) Patients with pathologically proven non-small cell lung cancer
2) Patients with EGFR mutation (exon 19 deletion, exon 21 L858R, T790M, exon 20 insertion, and other minor mutations)
3) Second line or later therapy of afatinib previously treated with EGFR-TKI
Key exclusion criteria 1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Kondo
Organization Nagoya University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 65 Tsurumai-cho, Showo-ku, Nagoya-City, Aichi, 466-8560, Japan
TEL 052-744-2167
Email mkond@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Hasegawa, Mitsuo Sato, Masahiro Morise, Tetsunari Hase, Naoyuki Yogo
Organization Nagoya University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 65 Tsurumai-cho, Showo-ku, Nagoya-City, Aichi, 466-8560, Japan
TEL 052-744-2167
Homepage URL
Email noa@med.nagoya-u.ac.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 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
2015 Year 03 Month 26 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
2015 Year 03 Month 09 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a retrospective observational study

Management information
Registered date
2015 Year 03 Month 26 Day
Last modified on
2015 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019634

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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