UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study Nivolumab in previously treated non-small-cell lung cancer subjects to evaluate the peripheral blood mononuclear cell immunological biomarker
Title of the study (Brief title)	Phase II study Nivolumab in previously treated non-small-cell lung cancer subjects to evaluate the peripheral blood mononuclear cell immunological biomarker
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	Evaluate the effectiveness of peripheral blood mononuclear cell imminological biomarker in nivolumab treatment
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	disease control rate at 9 weeks from nivolumab treatment
Key secondary outcomes	objective response rate,time to treatment failure, progression-free survival, overall survival, dropout rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	nivolumab monotherapy
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	1.Advanced non-small-cell lung cancer 2.History of one regimen or more cytotoxic chemotherapy 3.Twenty years and over 4.Expect survival for more than 3 months 5.ECOG PS 0-1 6.Having measurable leasions 7.Main organs function is maintained 8.With consent of the person or the substitute
Key exclusion criteria	1.Having history of immuno-checkpoint-inhibitor 2.Having history of autoimune disease 3.Having active or symptomatic interstitial lung disease 4.With infections requiring systemic treatment 5.Having symptomatic brain metastasis 6.Having poorly controlled diabetes 7.Having active liver disease 8.Having history of severe hypersensitivity 9.Patient judged inappropriate by the attending physician
Target sample size	60

Research contact person
Name of lead principal investigator	Hiroshi Kagamu
Organization	Saitame Medical University International Medical Center
Division name	division of respiratory medicine
Address	Hidaka city, Saitama
TEL	042-984-4111
Email	kagamu19@saitama-med.ac.jp

Public contact
Name of contact person	Ou Yamaguchi
Organization	Saitame Medical University International Medical Center
Division name	division of respiratory medicine
Address	Hidaka city, Saitama
TEL	042-984-4111
Homepage URL
Email	ouyamagu@saitama-med.ac.jp

Sponsor
Institute	Norst East Japan Study Group(NEJSG)
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

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 08 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 07 Month 19 Day
Anticipated trial start date	2017 Year 08 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 07 Month 31 Day
Last modified on	2018 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032589