UMIN-CTR Clinical Trial

Basic information
Public title	Biomarker studies for potentially predicting response to nivolumab in patients with unresectable or recurrent non-small cell lung cancer
Acronym	Biomarker studies for nivolumab
Scientific Title	Biomarker studies for potentially predicting response to nivolumab in patients with unresectable or recurrent non-small cell lung cancer
Scientific Title:Acronym	Biomarker studies for nivolumab
Region	Japan

Condition
Condition	unresectable or recurrent non-small cell lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the biomarkers for efficacy of nivolumab in patients with NSCLC
Basic objectives2	Others
Basic objectives -Others	Evaluation of biomarker
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate the biomarkers for efficacy of nivolumab using blood samples.
Key secondary outcomes	response rate, overall survival, progression-free survival, rate of side effects

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Leucocyte>3,000/mm3 and <12,000/mm3 Hemoglobin>9.0 g/dL Platelet>100,000/mm3 AST<100 IU/L ALT<100 IU/L T.Bil<2.0 mg/dL Serum creatinine<1.5 mg/dL
Key exclusion criteria	(1)Subjects with autoimmune disease. (2)Subjects with interstitial lung disease. (3)Receiving continuous systemic corticosteroid. (4)Prior therapy with antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. (5)Patients with a history of hypersensitivity to nivolumab. (6)Dementia or psychological disorder difficult to participate in this clinical study.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masami Sato
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of General Thoracic Surgery
Zip code
Address	8-35-1, Sakuragaoka, Kagoshima city, Japan
TEL	099-275-6490
Email	m-sato@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Toshiyuki Nagata
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of General Thoracic Surgery
Zip code
Address	8-35-1, Sakuragaoka, Kagoshima city, Japan
TEL	099-275-6490
Homepage URL
Email	nagatosh@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University
Institute
Department

Funding Source
Organization	Ono Pharmaceutical Co.,Ltd Bristol-Myers Squibb
Organization
Division
Category of Funding Organization	Profit organization
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	2017 Year 02 Month 07 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	Enrolling by invitation
Date of protocol fixation	2016 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date	2017 Year 02 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observational study study duration:22/Feb/2017-31/Dec/2022

Management information
Registered date	2017 Year 02 Month 07 Day
Last modified on	2018 Year 12 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029929

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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