UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022505 |
|---|---|
| Receipt number | R000025941 |
| Scientific Title | Exploratory study of biomarkers predicting response to nivolumab in non-small-cell lung cancer |
| Date of disclosure of the study information | 2016/06/30 |
| Last modified on | 2020/05/30 09:08:28 |
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Basic information
Public title
Exploratory study of biomarkers predicting response to nivolumab in non-small-cell lung cancer
Acronym
Study of biomarkers predicting response to nivolumab in NSCLC
Scientific Title
Exploratory study of biomarkers predicting response to nivolumab in non-small-cell lung cancer
Scientific Title:Acronym
Study of biomarkers predicting response to nivolumab in NSCLC
Region
| Japan |
Condition
Condition
Non-small-cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore biomarkers that can predict the efficacy of nivolumab in patients with NSCLC, PD-L1 and PD-L2 gene copy numbers in tumor cells, serum levels of soluble PD-L1, and profiles of leukocytes in patients treated with nivolumab are evaluated.
Basic objectives2
Others
Basic objectives -Others
Exploration of predictors for efficacy in nivolumab therapy
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Association of the response rate of nivolumab therapy with tumor PD-L1 and/or PD-L2 copy number alterations, PD-L1 and/or PD-L2 protein expression, serum levels of soluble PD-L1, and profiles of leukocytes.
Key secondary outcomes
Association of progression-free survival and overall survival of nivolumab therapy with tumor PD-L1 and/or PD-L2 copy number alterations, PD-L1 and/or PD-L2 protein expression, serum levels of soluble PD-L1, and profiles of leukocytes.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Receiving nivolumab therapy
2. Histologically proven advanced or recurrent NSCLC
3. Chemotherapy pre-treated
4. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
5. Adequate specimens available for FISH and IHC analyses
6. Life expectancy of more than 3 months
7. Aged equal to or greater than 18 years old
8. Written informed concent
Key exclusion criteria
1. Combined autoimmune disease or history of recurrent autoimmune disease
2. Interstitial lung disease
3. Severe medical comorbidities
4. Uncontrolled brain metastases
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
433125
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Japan
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Inoue |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3125
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Japan
TEL
053-435-2263
Homepage URL
yusukeinoue0421@yahoo.co.jp
Sponsor or person
Institute
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Japan
Tel
053-435-2111
rinri@hama-med.ac.jp
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
| 2016 | Year | 06 | Month | 30 | 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
200
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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
PD-L1 protein expression on NSCLC tumor cells has limited power to predict the effcicacy of nivolumab. Thus the objective of this research is to explore biomarkers that can predict the effectiveness of nivolumab in patients with NSCLC. PD-L1 and PD-L2 gene copy numbers in tissue samples, serum levels of soluble PD-L1, and profiles of leukocytes in pheripheral blood are evaluated.
Management information
Registered date
| 2016 | Year | 05 | Month | 27 | Day |
Last modified on
| 2020 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025941
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