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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026040
Receipt No. 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

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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
Email 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
Email nagatosh@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029929

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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