UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036606 |
|---|---|
| Receipt number | R000041556 |
| Scientific Title | Multicenter PK PD Study of Immune Checkpoint Inhibitors for Patients Aged 75 or Older with Advanced Non Small Cell Lung Cancer. |
| Date of disclosure of the study information | 2019/04/26 |
| Last modified on | 2024/04/28 09:38:22 |
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Basic information
Public title
PK/PD study of Pembrolizumab
Acronym
PK/PD study of Pembrolizumab
Scientific Title
Multicenter PK PD Study of Immune Checkpoint Inhibitors for Patients Aged 75 or Older with Advanced Non Small Cell Lung Cancer.
Scientific Title:Acronym
Elderly Pembro trial
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Analyses for K/PD/PGX, efficacy & safety, and biomarker in elderly patients with non-small cell lung cancer treated with pembrolizumab.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Pharmacokinetics of pembrolizumab
Key secondary outcomes
1)Responce rate
2)Disease control rate
3)Progression free survival
4)Overall survival
5)Adverse event
6)PK/PD/PGx
7)Biomarker
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histlogically or cytologically confirmed EGFR mutation positive non small cell lung cancer(NSCLC)
2)Patients who are going to treat with Pembrolizumab monotherapy or combination therapy.
3)No object about organ function, prior treatment, performance status, or measurable lesion.
4)More than 75 years old
5)Written informed consent
Key exclusion criteria
1)Patients who have treated with Pembrolizumab
2)Patients who denied to collect sample
3)Patients whose attending doctor consider as inappropriate for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akinobu |
| Middle name | |
| Last name | Hamada |
Organization
National Cancer Center Research Institute
Division name
Division of Molecular Pharmacology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, JAPAN
TEL
03-3542-2511
akhamad@ncc.go.jp
Public contact
Name of contact person
| 1st name | Shigehiro |
| Middle name | |
| Last name | Yagishita |
Organization
National Cancer Center Research Institute
Division name
Division of Molecular Pharmacology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, JAPAN
TEL
03-3542-2511
Homepage URL
syagishi@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Research Institute
Division of Molecular Pharmacology
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, JAPAN
Tel
03-3542-2511
syagishi@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
| 2019 | Year | 04 | Month | 26 | 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
100
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
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Efficacy, safety, PK/PD/PGx, and biomarker study for elderly patients with non-small cell lung cancer treated with pembrolizumab.
Management information
Registered date
| 2019 | Year | 04 | Month | 26 | Day |
Last modified on
| 2024 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041556
