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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023210
Receipt No. R000026757
Scientific Title prospective observational study to assess efficacy and safety of nivolumab in patients with recurrent non-small cell lung cancer
Date of disclosure of the study information 2016/07/19
Last modified on 2016/07/18

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Basic information
Public title prospective observational study to assess efficacy and safety of nivolumab in patients with recurrent non-small cell lung cancer
Acronym prospective observational study to assess efficacy and safety of nivolumab in patients with recurrent non-small cell lung cancer
Scientific Title prospective observational study to assess efficacy and safety of nivolumab in patients with recurrent non-small cell lung cancer
Scientific Title:Acronym prospective observational study to assess efficacy and safety of nivolumab in patients with recurrent non-small cell lung cancer
Region
Japan

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

Objectives
Narrative objectives1 We will reveal appropriate cases for nivolmab in patients with recurrent non-small cell lung cancer, by verifying a correlation between efficacy and safety of this agent and clinical characteristics.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes response rate and their clinical profiling
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)adequate patients to administrate nivolmab, after 1st line chemotherapy
2)patients who assent to this study
Key exclusion criteria 1)inadequate patients to administrate nivolmab
2)patients that the investigators identify inadequate for this study
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyoichi Kaira
Organization Gunma University Hospital
Division name department of translational medicine
Zip code
Address 3-39-15 Maebashi, Gunma, Japan
TEL 027-220-7111
Email kkaira1970@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinsuke Kitahara
Organization Gunma University Hospital
Division name department of respiratory and allergy medicine
Zip code
Address 3-39-15 Maebashi, Gunma, Japan
TEL 027-220-7111
Homepage URL
Email shinkita.s50@gmail.com

Sponsor
Institute Gunma University Hospital
Institute
Department

Funding Source
Organization Gunma University Hospital
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
2016 Year 07 Month 19 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
Date of protocol fixation
2016 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 07 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 prospective observational study
study duration:01/Jul/2016-30/Jun/2018

Management information
Registered date
2016 Year 07 Month 18 Day
Last modified on
2016 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026757

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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