UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032667 |
|---|---|
| Receipt number | R000037247 |
| Scientific Title | Retrospective observational study of salvage chemotherapy following nivolumab therapy in advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2019/05/22 09:41:26 |
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Basic information
Public title
Retrospective observational study of salvage chemotherapy following nivolumab therapy in advanced non-small cell lung cancer
Acronym
Retrospective exploratory study of salvage chemotherapy for nivolumab-refractory lung cancer
Scientific Title
Retrospective observational study of salvage chemotherapy following nivolumab therapy in advanced non-small cell lung cancer
Scientific Title:Acronym
Retrospective exploratory study of salvage chemotherapy for nivolumab-refractory lung cancer
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the anti-tumor activity in lung cancer patients receiving salvage chemotherapy following nivolumab therapy and investigate the tumor immune microenvironment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint is overall response of salvage chemotherapy in association with the characteristics of tumor-infiltrating immune cells.
Key secondary outcomes
The secondary endpoint is progression-free survival of salvage chemotherapy,
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Ww enroll the patients with relapsed or advanced non-small cell lung cancer who underwent salvage chemotherapy following progression after conventional cytotoxic chemotherapy and the subsequent nivolumab therapy.
Key exclusion criteria
The patients are excluded from the analysis if they had another neoplasm for the need of treatment, and if they received the preceding therapy of EGFR or ALK throsine kinase inhibitors before or after nivolumab therapy.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | HIroshi |
| Middle name | |
| Last name | Soda |
Organization
Sasebo City General Hospital
Division name
Department of Respiratory Medicine
Zip code
857-8511
Address
9-3, Hirase, Sasebo, Nagasaki, Japan
TEL
0956-24-1515
h-souda@hospital.sasebo.nagasaki.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Soda |
Organization
Sasebo City General Hospital
Division name
Department of Respiratory Medicine
Zip code
857-8511
Address
9-3, Hirase, Sasebo, Nagasaki, Japan
TEL
0956-24-1515
Homepage URL
h-souda@hospital.sasebo.nagasaki.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Sasebo City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Sasebo City General Hospital
Address
9-3, Hirase, Sasebo, Nagasaki, 857-8511
Tel
0956-24-1515
c-jimusitsu@hospital.sasebo.nagasaki.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
佐世保市総合医療センター（長崎県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/30126069
Number of participants that the trial has enrolled
15
Results
Both few PD-1 positive immune cells in the tumor and decreased NLR ratio during the treatment may predict the improved response to salvage chemotherapy following nivolumab for lung cancer.
Results date posted
| 2019 | Year | 05 | Month | 22 | Day |
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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Retrospective observational study (Case-series analysis)
Management information
Registered date
| 2018 | Year | 05 | Month | 21 | Day |
Last modified on
| 2019 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037247
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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