UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051069 |
|---|---|
| Receipt number | R000058235 |
| Scientific Title | Study for examining residual durvalumab effect on immune system after durvalumab consolidation therapy in unresectable locally advanced non-small cell lung cancer. |
| Date of disclosure of the study information | 2023/05/16 |
| Last modified on | 2023/05/16 12:07:01 |
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Basic information
Public title
Study for examining residual durvalumab effect on immune system after durvalumab consolidation therapy in unresectable locally advanced non-small cell lung cancer.
Acronym
PKPD study of durvalumab
Scientific Title
Study for examining residual durvalumab effect on immune system after durvalumab consolidation therapy in unresectable locally advanced non-small cell lung cancer.
Scientific Title:Acronym
PKPD study of durvalumab
Region
| Japan |
Condition
Condition
Non-small cell lung cancer treated with durvalumab
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the transition of drug residuals and immune effects in unresectable locally advanced non-small cell lung cancer (NSCLC) after durvalumab therapy over time.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Changes in blood levels and immune status after completion of durvalumab treatment
Key secondary outcomes
1) Progression free survival (PFS)
2) Overall survival (OS)
3) Adverse event rate
4) Pharmacogenetic analysis
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
1) Patients with histologically or cytologically diagnosed NSCLC
2) Patients who are expected to complete durvalumab therapy following radical chemoradiotherapy for unresectable locally advanced NSCLC.
3) Patients who have given their written consent to participate in this study.
Key exclusion criteria
1) Patients who cannot give consent for specimen collection
2) Other patients who are judged by the principal investigator or the physician in charge to be inappropriate as subjects for this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hidehito |
| Middle name | |
| Last name | Horinouchi |
Organization
National Cancer Center Hospital
Division name
Department of Respiratory Medicine
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, JAPAN
TEL
0335422511
hhorinou@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
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
0335422511
Homepage URL
syagishi@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Hidehito Horinouchi
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Reiew Board
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Tel
0335422511
irst@ml.res.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
| 2023 | Year | 05 | Month | 16 | 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
| 2019 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 05 | Month | 16 | Day |
Last modified on
| 2023 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058235
| 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 |
