UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023433 |
|---|---|
| Receipt number | R000026982 |
| Scientific Title | A single arm confirmatory study of nivolumab in patients with previously treated advanced sarcomatoid carcinoma of the lung |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2020/06/06 15:35:21 |
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Basic information
Public title
A single arm confirmatory study of nivolumab in patients with previously treated advanced sarcomatoid carcinoma of the lung
Acronym
Nivolumab for advanced sarcomatoid carcinoma of the lung
Scientific Title
A single arm confirmatory study of nivolumab in patients with previously treated advanced sarcomatoid carcinoma of the lung
Scientific Title:Acronym
Nivolumab for advanced sarcomatoid carcinoma of the lung
Region
| Japan |
Condition
Condition
advanced sarcomatoid carcinoma of the lung
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To confirm effect and safety of nivolumab in patients with advanced sarcomatoid carcinoma of the lung.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall response rate by Central review
Key secondary outcomes
Overall response rate by investigator, PFS, OS, DCR, Survival rate at 6 months, and toxicity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed sarcomatoid carcinoma of the lung
2. Stage III, IV, and postoperative recurrence
3. Age > 20
4. PS 0-2
5. Measurable lesion
6. Adequate organ function
7. Written informed consent
Key exclusion criteria
1. Active auto-immune disease
2. Interstitial lung disease or pulmonary fibrosis
3. Active infection such as bacteria, HBV, or HCV
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Ohe |
Organization
National Cancer Center Hospital
Division name
Department of Thoracic Oncology
Zip code
104-0045
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL
03-3542-2511
yohe@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Fujiwara |
Organization
National Cancer Center Hospital
Division name
Department of Thoracic Oncology
Zip code
104-0045
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
yutakafu@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center 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
National Cancer center Hospital
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
Tel
03-3542-2511
yutakafu@ncc.go.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 | 11 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 02 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 01 | Day |
Last modified on
| 2020 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026982
| 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 |
