UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023540 |
|---|---|
| Receipt number | R000027111 |
| Scientific Title | Soluble programmed cell death ligand-1 as a possible predictive marker for anti-programmed cell death-1 antibody therapy against non-small lung cancers |
| Date of disclosure of the study information | 2016/08/08 |
| Last modified on | 2020/08/14 10:35:27 |
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Basic information
Public title
Soluble programmed cell death ligand-1 as a possible predictive marker for anti-programmed cell death-1 antibody therapy against non-small lung cancers
Acronym
Soluble PD-L1 as a possible predictive marker for anti-PD-1 mAb therapy against NSCLCs
Scientific Title
Soluble programmed cell death ligand-1 as a possible predictive marker for anti-programmed cell death-1 antibody therapy against non-small lung cancers
Scientific Title:Acronym
Soluble PD-L1 as a possible predictive marker for anti-PD-1 mAb therapy against NSCLCs
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Usefulness of blood soluble programmed cell death ligand-1 (sPD-L1) as a predictive marker for anti-programmed cell death-1 (PD-1) monoclonal antibody therapy agianst non-small cell lung cancers will be determined.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood sPD-L1 level is a predictive marker for the clinical results of anti-PD-1 mAb therapy agaist NSCLCs.
Key secondary outcomes
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
NSCLC patients over 20 years old who will be treated with Nivolumab and have agreed to examine their own blood sPD-L1 level by a document.
Key exclusion criteria
NSCLC patients who will be treated with Nivolumab but have not agreed to examine their own blood sPD-L1 level.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sadamu |
| Middle name | |
| Last name | Homma |
Organization
Jikei University School of Medicine
Division name
Division of Oncology
Zip code
105-8461
Address
3-25-8 Nishi-shimbashi Minato-ku Tokyo 105-8461 Japan
TEL
+81334331111
sahya@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Sadamu |
| Middle name | |
| Last name | Homma |
Organization
Jikei University School of Medicine
Division name
Division of Oncology
Zip code
105-8461
Address
3-25-8 Nishi-shimbashi Minato-ku Tokyo 105-8461 Japan
TEL
03-3433-1111
Homepage URL
sahya@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jikei University IRB
Address
3-25-8 Nishi-shimbashi Minato-ku
Tel
+81334331111
rinri@jikei.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 | 08 | Month | 08 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/29859759/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/29859759
Number of participants that the trial has enrolled
39
Results
Of the 39 patients, 59% with low plasma sPD-L1 levels achieved a complete response or partial response and 25% of those with high plasma sPD-L1 levels did so. In addition, 22% of the patients with low plasma sPD-L1 levels developed progressive disease compared with 75% of those with high plasma sPD-L1 levels. The TTF and OS were significantly longer in low sPD-L1 group than in high sPD-L1 group.
Results date posted
| 2020 | Year | 08 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients of non-small cell lung cancer(NSCLC) treated with nivolumab
Participant flow
Cohort groups were determined in the patients of NSCLC in Jikei University Hospital.
Adverse events
none
Outcome measures
Tumor size, time to treatment failure (TTF), and overall survival (OS).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Nothing in particular
Management information
Registered date
| 2016 | Year | 08 | Month | 08 | Day |
Last modified on
| 2020 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027111
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