UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study of biomarkers to predict efficacy after Nivolumab in patients with previously treated advanced non-small cell lung cancer.
Acronym	Exploration of biomarker after Nivolumab in lung cancer
Scientific Title	Prospective observational study of biomarkers to predict efficacy after Nivolumab in patients with previously treated advanced non-small cell lung cancer.
Scientific Title:Acronym	Exploration of biomarker after Nivolumab in lung cancer
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	Nivolumab is active for treatment of previously treated NSCLC. However, there have been no established biomarker to predict the efficcy and outcome after administration of Nivolumab. In this study, we explored the promising markers as a prediction of Nivolumab using blood samples.
Basic objectives2	Others
Basic objectives -Others	We analyze the expression of PD-L1 within circulating cancer cells by CTC methods.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To explore the pretictive biomarkers after and before Nivolumab using blood samples.
Key secondary outcomes	Potential of monitoring Nivolumab by any biomarkers

Base
Study type	Observational

Study design
Basic design
Randomization
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Blinding
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Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Candidate for administration of nivolumab with written informed consent
Key exclusion criteria	Judgement as exclusion by chief mdical physians having auto-immune diseases
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kyoichi Kaira
Organization	Gunma University
Division name	Oncology Clinical Development
Zip code
Address	showa-machi. Maebashi, Gunma
TEL	027-220-8136
Email	kkaira1970@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Kyoichi Kaira
Organization	Gunma University
Division name	Oncology Clinical Development
Zip code
Address	showa-machi. Maebashi, Gunma
TEL	027-220-8136
Homepage URL
Email	kkaira1970@yahoo.co.jp

Sponsor
Institute	Gunma University
Institute
Department

Funding Source
Organization	Ono Pharmaceutical Co.,Ltd., Bristol-Myers Squibb K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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IRB Contact (For public release)
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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 02 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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Baseline Characteristics
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Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date	2016 Year 02 Month 01 Day
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Other

Other related information

Study design; Cohort study Registration: Feb. 2016 to Jan. 2019, compatible with inclusion criteria Using blood sample, any biomarkers before and after nivolumab administration and measured. In the first 5 patients, several points after 1,2,3,4w, 3m,6m and PD are assessed to find an appropriate point after nivolumab. Where we idenfy an optimal point, two points before and afternivolumab are evaluated. Any blood samples are used to do CTC and exosome analysis, examining immune enviromental biomarkers such as PD-L1, PD-L2, CD4 and CD8. We explored the relationship between the efficacy of nivolumab and the expression level of these markers.

Management information
Registered date	2016 Year 02 Month 01 Day
Last modified on	2016 Year 09 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024033

Research Plan
Registered date	File name

Research case data specifications
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Research case data
Registered date	File name

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