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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030457
Receipt No. 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 2017/12/18

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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
Middle name
Last name Kazuyoshi Imaizumi
Organization Fujita Health University School
Division name Medicine department of pulmonary
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL 0562-93-9241
Email jeanluc@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Goto
Organization Fujita Health University School
Division name Medicine department of pulmonary
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL 0562-93-9241
Homepage URL
Email gotoyasu510@hotmail.com

Sponsor
Institute Fujita Health University School
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2017 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 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 12 Month 18 Day
Last modified on
2017 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034774

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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