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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025261
Receipt No. R000029032
Scientific Title Multi-institutional retrospective observational study of effectiveness and safety of treatment with Nivolmab for advanced or recurrent non-small cell lung cancer harboring EGFR mutation.
Date of disclosure of the study information 2016/12/31
Last modified on 2016/12/14

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Basic information
Public title Multi-institutional retrospective observational study of effectiveness and safety of treatment with Nivolmab for advanced or recurrent non-small cell lung cancer harboring EGFR mutation.
Acronym Multi-institutional retrospective observational study of effectiveness and safety of treatment with Nivolmab for advanced or recurrent non-small cell lung cancer harboring EGFR mutation.
Scientific Title Multi-institutional retrospective observational study of effectiveness and safety of treatment with Nivolmab for advanced or recurrent non-small cell lung cancer harboring EGFR mutation.
Scientific Title:Acronym Multi-institutional retrospective observational study of effectiveness and safety of treatment with Nivolmab for advanced or recurrent non-small cell lung cancer harboring EGFR mutation.
Region
Japan

Condition
Condition Non-small cell Lung Cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the effectiveness and safety of the treatment with Nivolmab for the advanced or recurrent non-small cell lung cancer patients harboring EGFR mutation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes effectiveness and safety
Key secondary outcomes Response rate
Progression free survival
Overall survival
Adverse events

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 NSCLC patients harboring EGFR gene mutation, who were treated with Nivolmab by the end of December 2016, are eligible for this study.
Key exclusion criteria Nothing
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahide Mori
Organization Toneyama National Hospital
Division name Department of Thoracic Oncology
Zip code
Address 5-1-1,Toneyama, Toyonaka-city, Osaka
TEL 06-6853-2001
Email mmori@toneyama.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Akazawa
Organization Toneyama National Hospital
Division name Department of Thoracic Oncology
Zip code
Address 5-1-1,Toneyama, Toyonaka-city, Osaka
TEL 06-6853-2001
Homepage URL
Email akazaway@toneyama.go.jp

Sponsor
Institute HANSHIN Oncology Group
Institute
Department

Funding Source
Organization HANSHIN Oncology Group
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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 HANSHIN 0416
Org. issuing International ID_1 HANSHIN Oncology Group
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立病院機構刀根山病院(大阪府)、先端医療センター(兵庫県)、兵庫県立がんセンター(兵庫県)、大阪府立成人病センター(兵庫県)、神戸大学医学部附属病院(兵庫県)、宝塚市立病院(兵庫県)、京都桂病院(京都府)、関西医科大学枚方病院(大阪府)を予定

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 31 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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This retrospective study will be performed based on the patient's clinical records.

Management information
Registered date
2016 Year 12 Month 13 Day
Last modified on
2016 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029032

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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