UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026129 |
|---|---|
| Receipt number | 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 | 2022/01/09 08:15:57 |
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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
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
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
Kobe city medical center general hospital
Address
2-1-1, minatojima-minamimachi, chuo-ku, 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
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
Completed
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
| 2022 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029759
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