UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028468 |
|---|---|
| Receipt number | 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 23:36:25 |
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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
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
ouyamagu@saitama-med.ac.jp
Sponsor or person
Institute
Norst East Japan Study Group(NEJSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032589
