UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021560 |
|---|---|
| Receipt number | 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 | 2023/03/08 19:02:04 |
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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 | Daichi |
| Middle name | |
| Last name | Fujimoto |
Organization
Kobe city medical center general hospital
Division name
Respiratory medicine
Zip code
650-0045
Address
2-1-1,minatojima minamimachi,chuuouku,Kobe city
TEL
078-302-4321
daichi@kcho.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Teraoka |
Organization
Kobe city medical center general hospital
Division name
Respiratory medicine
Zip code
650-0045
Address
2-1-1,minatojima minamimachi,chuuouku,Kobe city
TEL
078-302-4321
Homepage URL
s.teraoka1105@gmail.com
Sponsor or person
Institute
Kobe city medical center general hospital
Institute
Department
Personal name
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
Kobe city medical center general hospital
Address
2-1-1, Minatojima, Kobe
Tel
078-302-4321
rinken@kcho.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 | 03 | Month | 24 | Day |
Related information
URL releasing protocol
N/A
Publication of results
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
43
Results
Patients with irAEs were associated with a significantly longer median progression-free survival than those without. These findings were comparable to those for patients with and without irAEs 6 weeks after commencement of nivolumab treatment.
Results date posted
| 2023 | Year | 03 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients with advanced NSCLC who were treated with nivolumab between January and December 2016
Participant flow
prospective cohort with advanced NSCLC who were treated with nivolumab between January and December 2016
Adverse events
N/A
Outcome measures
Early irAEs and survival data
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 20 | Day |
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
| 2023 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024772
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
