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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000021694
Receipt No. R000024740
Scientific Title Single-institutional observational surveillance of nivolumab for previously treated with non-small cell lung cancer
Date of disclosure of the study information 2016/04/01
Last modified on 2019/03/22

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Basic information
Public title Single-institutional observational surveillance of nivolumab for previously treated with non-small cell lung cancer
Acronym observational study of nivolumab
Scientific Title Single-institutional observational surveillance of nivolumab for previously treated with non-small cell lung cancer
Scientific Title:Acronym observational study of nivolumab
Region
Japan

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

Objectives
Narrative objectives1 To investigate the predictive factor response with clinical characteristics
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes response rate
Key secondary outcomes progression-free survival; overall survival; safety; predictive factor of prognosis and safety

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 All patients treated with nivolumab for previously treated with NSCLC from 2016
Key exclusion criteria inadequate patients for nivolumab treatment
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yusuke
Middle name
Last name Okuma
Organization Tokyo Metropolitan Komagome Hospital
Division name Department of Thoracic Oncology
Zip code 113-8677
Address 3-18-22, Honkomagome, Bunkyo, Tokyo, JAPAN
TEL 03-3823-2101
Email y-okuma@cick.jp

Public contact
Name of contact person
1st name Yusuke
Middle name
Last name Okuma
Organization Tokyo Metropolitan Komagome Hospital
Division name Department of Thoracic Oncology
Zip code 113-8677
Address 3-18-22, Honkomagome, Bunkyo, Tokyo, JAPAN
TEL 03-3823-2101
Homepage URL
Email y-okuma@cick.jp

Sponsor
Institute Tokyo Metropolitan Komagome Hospital
Institute
Department

Funding Source
Organization Tokyo Metropolitan Komagome 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 Ethics committee of Tokyo Metropolitan Komagome Hospital
Address 3-28-22, Honkomagome, Bunkyo, Tokyo
Tel 03-3823-2101
Email rinri@cick.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
2016 Year 04 Month 01 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/30655989
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/30655989
Number of participants that the trial has enrolled 67
Results 
The patients who were treated with nivolumab as the standard of care were enrolled.
Results date posted
2019 Year 03 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
The patients who were treated with nivolumab as the standard of care were enrolled.
Participant flow 
The patients who were treated with nivolumab as the standard of care were enrolled.
Adverse events 
we have published in the articles
Outcome measures 
we have published in the articles
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2016 Year 03 Month 12 Day
Date of IRB
2016 Year 04 Month 01 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Case control study. We will assess clinical demographic, diagnosis, histological subtypes, treatment of nivolumab, clinical outcome (response, time-to-event), or laboratory data.

Management information
Registered date
2016 Year 03 Month 30 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024740

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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