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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021560
Receipt No. R000024772
Scientific Title A study to evaluate the relation between the efficacy and early Immune Related Advers Events of Nivolmab in patients with non-small cell lung cancer
Date of disclosure of the study information 2016/03/24
Last modified on 2018/09/23

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Basic information
Public title A study to evaluate the relation between the efficacy and early Immune Related Advers Events of Nivolmab in patients with non-small cell lung cancer
Acronym A study to evaluate the relation between the efficacy and early Immune Related Advers Events of Nivolmab in patients with non-small cell lung cancer
Scientific Title A study to evaluate the relation between the efficacy and early Immune Related Advers Events of Nivolmab in patients with non-small cell lung cancer
Scientific Title:Acronym A study to evaluate the relation between the efficacy and early Immune Related Advers Events of Nivolmab in patients with non-small cell lung cancer
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the relation between the efficacy and early Immune-Related Adverse Events of Nivolmab in patients with non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes objective response rate,progression free survival
Key secondary outcomes disease control rate
overall survival

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
100 years-old >=
Gender Male and Female
Key inclusion criteria 1)Age of 20 years old and older than 20 years old.
2)Histologically and/or cytologically proven non-small cell lung cancer.
3)Clinical stage IIIB without indication of definitive thoracic radiotherapy, stage IV, or postoperative recurrent disease.
4)ECOG performance status 0-2.
5)Adequate organ function.
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)Dementia or psychological disorder difficult to participate in this clinical study.
6)Uncontrolled intercurrent illness including symptomatic cardiac arrhythmia, or diabetes,
Intestinal obstruction.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fujimoto Daichi
Organization Kobe city medical center general hospital
Division name Respiratory medicine
Zip code
Address 2-1-1,minatojima minamimachi,chuuouku,Kobe city
TEL 078-302-4321
Email daichi@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teraoka Shunsuke
Organization Kobe city medical center general hospital
Division name Respiratory medicine
Zip code
Address 2-1-1,minatojima minamimachi,chuuouku,Kobe city
TEL 078-302-4321
Homepage URL
Email s.teraoka1105@gmail.com

Sponsor
Institute Kobe city medical center general hospital
Institute
Department

Funding Source
Organization No
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
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
2016 Year 03 Month 24 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications https://www.jto.org/article/S1556-0864(17)30825-0/abstract
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 No longer recruiting
Date of protocol fixation
2016 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 20 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cohort study
Non-small cell lung cancer patients who consult Kobe city medical center general hospital after January 2016 and who is eligible for the inclusion criteria

Management information
Registered date
2016 Year 03 Month 22 Day
Last modified on
2018 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024772

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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