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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000026129
Receipt No. R000029759
Scientific Title The prospective study of nivolumab for advanced NSCLC patients with mild IIPs
Date of disclosure of the study information 2017/02/15
Last modified on 2020/02/17

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Basic information
Public title The prospective study of nivolumab for advanced NSCLC patients with mild IIPs
Acronym The prospective study of nivolumab for advanced NSCLC patients with mild IIPs
Scientific Title The prospective study of nivolumab for advanced NSCLC patients with mild IIPs
Scientific Title:Acronym The prospective study of nivolumab for advanced NSCLC patients with mild IIPs
Region
Japan

Condition
Condition non-small cell lung cancer
interstitial lung disease
interstitial pneumonia
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 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes progression free survival
Key secondary outcomes overall survival, response rate, duration of response, safety

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 18

Research contact person
Name of lead principal investigator
1st name Keisuke
Middle name
Last name Tomii
Organization Kobe city medical center general hospital
Division name Division of respiratory medicine
Zip code 650-0047
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 Daichi
Middle name
Last name Fujimoto
Organization Kobe city medical center general hospital
Division name Division of respiratory medicine
Zip code 650-0047
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 Kobe city medical center general hospital
Address 2-1-1, minatojima-minamimachi, chuo-ku, Kobe
Tel 078-302-4321
Email 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 神戸市立医療センター西市民病院
神奈川県立循環器呼吸器病センター
東京都立駒込病院

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 15 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/31182249
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/31182249
Number of participants that the trial has enrolled 18
Results Results: Eighteen patients were enrolled in this trial. Six months PFS rate was 56%, response rate was 39%, and
disease control rate was 72%. There were no treatment-related deaths. One drug-related grade 3/4 nonhematologic
event (grade 3 neurotoxicity) was observed. Two patients had grade 2 pneumonitis which improved
by corticosteroid therapy.
Conclusions: Nivolumab could be an effective therapy for NSCLC patients with mild IIPs.
Results date posted
2020 Year 02 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Eligible patients had previously-treated, inoperable NSCLC with mild IIPs.
Participant flow Eligible patients had previously-treated, inoperable NSCLC with mild IIPs.
Adverse events One drug-related grade 3/4 nonhematologic
event (grade 3 neurotoxicity) was observed. Two patients had grade 2 pneumonitis which improved
by corticosteroid therapy.
Outcome measures Six months PFS rate was 56%.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2017 Year 02 Month 13 Day
Date of IRB
2017 Year 02 Month 13 Day
Anticipated trial start date
2017 Year 02 Month 14 Day
Last follow-up date
2018 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
2018 Year 12 Month 28 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 14 Day
Last modified on
2020 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029759

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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