UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062700 |
|---|---|
| Receipt number | R000071783 |
| Scientific Title | Pembrolizumab dose-optimization study with Regression discontinuity design In patients with non-small cell lung Cancer to avert Excessive toxicity and cost (PRICE): Sub-study |
| Date of disclosure of the study information | 2026/08/27 |
| Last modified on | 2026/08/26 15:56:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Pembrolizumab dose-optimization study with Regression discontinuity design In patients with non-small cell lung Cancer to avert Excessive toxicity and cost (PRICE): Sub-study
Acronym
PRICE Sub-study
Scientific Title
Pembrolizumab dose-optimization study with Regression discontinuity design In patients with non-small cell lung Cancer to avert Excessive toxicity and cost (PRICE): Sub-study
Scientific Title:Acronym
PRICE Sub-study
Region
| Japan |
Condition
Condition
Non-Small Cell Lung Cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In patients enrolled in the PRICE trial who meet all the eligibility criteria for this sub-study, to measure the plasma concentrations of pembrolizumab and conduct an exploratory analysis to identify the optimal dose of pembrolizumab.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of plasma concentration trends of pembrolizumab
Key secondary outcomes
Correlation between the clinical efficacy of pembrolizumab and its plasma concentrations in the PRICE trial
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
1) Patients enrolled in the PRICE trial
2) Patients who have provided written informed consent to participate in this sub-study
Key exclusion criteria
1) Patients from whom consent cannot be obtained for specimen collection
2) Any other patients whom the principal investigator or the attending physician determines are not suitable for inclusion in this sub-study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Kunitoh |
Organization
Japanese Red Cross Medical Center
Division name
Department of Medical Oncology
Zip code
150-8935
Address
4-1-22 Hiroo,Shibuya-ku,Tokyo
TEL
03-3400-1311
kunito_hideo@med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Kageaki |
| Middle name | |
| Last name | Watanabe |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Department of Thoracic Oncology & Respiratory Medicine
Zip code
113-8677
Address
3-18-22, Honkomagome, Bunkyo-ku, Tokyo
TEL
03-3823-2101
Homepage URL
kageaki_watanabe@tmhp.jp
Sponsor or person
Institute
Public Health Research Foundation
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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 Institutional Review Board
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
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
| 2026 | Year | 08 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Methods
1) Enroll patients after obtaining written informed consent from the patient.
2) The pembrolizumab dosing schedule shall follow the PRICE trial protocol.
3) Blood samples for assessing pembrolizumab plasma concentrations shall be collected in addition to routine blood draws during clinic visits.
For pembrolizumab administered every 3 weeks: Before the start of the third treatment cycle (up to 3 days prior)
For pembrolizumab administered every 6 weeks: Prior to the start of the second treatment cycle (up to 3 days prior)
For pembrolizumab administered every 3 weeks: Prior to the start of the fifth treatment cycle (up to 3 days prior)
For pembrolizumab administered every 6 weeks: Prior to the start of the third treatment cycle (up to 3 days prior)
Management information
Registered date
| 2026 | Year | 08 | Month | 26 | Day |
Last modified on
| 2026 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071783
