UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022037 |
|---|---|
| Receipt number | R000024914 |
| Scientific Title | The pilot study of nivolumab for advanced NSCLC patients with IIPs which is clinically considered to be at low risk of acute exacerbation of IIPs. |
| Date of disclosure of the study information | 2016/04/24 |
| Last modified on | 2017/02/14 14:36:22 |
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Basic information
Public title
The pilot study of nivolumab for advanced NSCLC patients with IIPs which is clinically considered to be at low risk of acute exacerbation of IIPs.
Acronym
IP-NSCLC nivolumab study
Scientific Title
The pilot study of nivolumab for advanced NSCLC patients with IIPs which is clinically considered to be at low risk of acute exacerbation of IIPs.
Scientific Title:Acronym
IP-NSCLC nivolumab study
Region
| Japan |
Condition
Condition
Advanced NSCLC patients with IIPs
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate safety and efficacy of nivolumab in advanced NSCLC with IIPs
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Key secondary outcomes
Response rate, progression free survival
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Pathologically proven NSCLC
2)Subjects with IIPs which meets the criteria below
I)VC is more than 80 percent of predicted
II)Possible UIP or inconsistent UIP
3)Advanced stage
4)Second line or beyond
5)No IIPs worsening due to previous chemotherapy
Key exclusion criteria
1)Subjects with the history of drug induced pneumonitis
2)Subjects with definite UIP pattern
3)Subjects with serious infection
4)Subjects with serious complications
5)Subjects with symptomatic brain metastases
6)Subjects with uncontrolled pleural effusion, ascites, and pericardial effusion
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Tomii |
Organization
Kobe city medical center general hospital
Division name
Division of respiratory medicine
Zip code
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047, Japan
TEL
078-302-4321
ktomii@kcho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daichi Fujimoto |
Organization
Kobe city medical center general hospital
Division name
Division of respiratory medicine
Zip code
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047, Japan
TEL
078-302-4321
Homepage URL
daichi@kcho.jp
Sponsor or person
Institute
Kobe city medical center general hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe city medical center general hospital
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
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 | 04 | Month | 24 | 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
| 2016 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 21 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 14 | Day |
Date trial data considered complete
| 2017 | Year | 02 | Month | 14 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 24 | Day |
Last modified on
| 2017 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024914
| Research Plan | |
|---|---|
| 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 |
