UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026040 |
|---|---|
| Receipt number | R000029929 |
| Scientific Title | Biomarker studies for potentially predicting response to nivolumab in patients with unresectable or recurrent non-small cell lung cancer |
| Date of disclosure of the study information | 2017/02/07 |
| Last modified on | 2018/12/16 10:45:38 |
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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
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
nagatosh@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029929
