UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046353 |
|---|---|
| Receipt number | R000052616 |
| Scientific Title | Safety and efficacy of combination immunotherapy with nivolumab and ipilimumab for elderly lung cancer patients: a cohort study |
| Date of disclosure of the study information | 2021/12/12 |
| Last modified on | 2021/12/11 13:10:24 |
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Basic information
Public title
Safety and efficacy of combination immunotherapy with nivolumab and ipilimumab for elderly lung cancer patients: a cohort study
Acronym
Safety and efficacy of combination immunotherapy with nivolumab and ipilimumab for elderly lung cancer patients: a cohort study
Scientific Title
Safety and efficacy of combination immunotherapy with nivolumab and ipilimumab for elderly lung cancer patients: a cohort study
Scientific Title:Acronym
Safety and efficacy of combination immunotherapy with nivolumab and ipilimumab for elderly lung cancer patients: a cohort study
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy and safety of combination immunotherapy with ipilimumab and nivolumab for 75-year-old or older lung cancer patients compared with those for younger than 75 years of age
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall response rate, incidence of adverse events
Key secondary outcomes
duration of treatment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Advanced or recurrent non-small cell lung cancer patients who receive combination immunotherapy with nivolumab and ipilimumab
Key exclusion criteria
None
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Imakita |
Organization
Kyoto Medical Center
Division name
Division of Respiratory Medicine
Zip code
6128555
Address
1-1 Fukakusamukaihatacho, Fushimi, Kyoto, Japan
TEL
0756419161
imakita-kyt@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Imakita |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Respiratory Medicine
Zip code
6128555
Address
1-1 Fukakusamukaihatacho, Fushimi, Kyoto, Japan
TEL
0756419161
Homepage URL
imakita-kyt@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kyoto Medical Center
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 Hospital Organization Kyoto Medical Center
Address
1-1 Fukakusamukaihatacho, Fushimi, Kyoto, Japan
Tel
0756419161
404-chiken@mail.hosp.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
| 2021 | Year | 12 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study: enrolling
Management information
Registered date
| 2021 | Year | 12 | Month | 11 | Day |
Last modified on
| 2021 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052616
