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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022037
Receipt No. 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

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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
Email 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
Email daichi@kcho.jp

Sponsor
Institute Kobe city medical center general hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024914

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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