UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025261 |
|---|---|
| Receipt number | 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 19:17:36 |
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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
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
akazaway@toneyama.go.jp
Sponsor or person
Institute
HANSHIN Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029032
