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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028468
Receipt No. R000032589
Scientific Title Phase II study Nivolumab in previously treated non-small-cell lung cancer subjects to evaluate the peripheral blood mononuclear cell immunological biomarker
Date of disclosure of the study information 2017/08/01
Last modified on 2018/11/16

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Basic information
Public title Phase II study Nivolumab in previously treated non-small-cell lung cancer subjects to evaluate the peripheral blood mononuclear cell immunological biomarker
Acronym Phase II study Nivolumab in previously treated non-small-cell lung cancer subjects to evaluate the peripheral blood mononuclear cell immunological biomarker
Scientific Title Phase II study Nivolumab in previously treated non-small-cell lung cancer subjects to evaluate the peripheral blood mononuclear cell immunological biomarker
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Kagamu
Organization Saitame Medical University International Medical Center
Division name division of respiratory medicine
Zip code
Address Hidaka city, Saitama
TEL 042-984-4111
Email kagamu19@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ou Yamaguchi
Organization Saitame Medical University International Medical Center
Division name division of respiratory medicine
Zip code
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)

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 08 Month 01 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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 19 Day
Date of IRB
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

Other
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

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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