UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030457 |
|---|---|
| Receipt number | R000034774 |
| Scientific Title | Phase II trial of early secondary treatment with nibolumab for non-small cell lung cancer |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2021/06/21 14:17:02 |
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Basic information
Public title
Phase II trial of early secondary treatment with nibolumab for non-small cell lung cancer
Acronym
Early secondary treatment with nibolumab for NSCLC
Scientific Title
Phase II trial of early secondary treatment with nibolumab for non-small cell lung cancer
Scientific Title:Acronym
Early secondary treatment with nibolumab for NSCLC
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The effectiveness and safety of early nibolab secondary treatment after primary treatment with platinum drug combination.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Disease control rate at 24 weeks after initiation of nivolumab therapy
Key secondary outcomes
Progression-free survival, Overall survival, Time to treatment failure, Response rate, Adverse events
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 3mg/kg every 2 weeks
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
Pathologically diagnosed non-small-cell
Non-small-cell lung cancer of stage IIIB or IV
Reccurence of operation or concurrent chemoradiotherapy
Patients without driver gene mutation (i.e. EGFR/ALK/RET/ROS1)
Expression of PD-L1 in adenocarcinoma are 0-49%
Expression of PD-L1 in squamouscarcinoma are 1-49%
Adequate organ function
3 months or longer expected survival
Written informed consent
Age over 20 years old
ECOG PS 0-1
Measurable lesion
Key exclusion criteria
Active auto-immune disease
An inappropriate case judged by doctor in charge
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Imaizumi |
Organization
Fujita Health University School
Division name
Medicine department of pulmonary
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9241
jeanluc@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Goto |
Organization
Fujita Health University School
Division name
Medicine department of pulmonary
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9241
Homepage URL
gotoyasu510@hotmail.com
Sponsor or person
Institute
Fujita Health University School
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University School
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
Tel
0562-93-9241
gotoyasu510@hotmail.com
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
| 2018 | Year | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 18 | Day |
Last modified on
| 2021 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034774
