UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063597 |
|---|---|
| Receipt number | R000072457 |
| Scientific Title | Investigation of Genetic Polymorphisms Associated with the Clinical Efficacy of Immune Checkpoint Inhibitors in Patients with Non-Small Cell Lung Cancer Using Surgical Specimens |
| Date of disclosure of the study information | 2026/11/13 |
| Last modified on | 2026/11/11 18:41:55 |
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Basic information
Public title
A Study on Genetic Differences Associated with the Effects of Cancer Immunotherapy in Patients with Non-Small Cell Lung Cancer Who Have Undergone Surgery
Acronym
Study of Genetic Differences Associated with Cancer Immunotherapy Effects in NSCLC
Scientific Title
Investigation of Genetic Polymorphisms Associated with the Clinical Efficacy of Immune Checkpoint Inhibitors in Patients with Non-Small Cell Lung Cancer Using Surgical Specimens
Scientific Title:Acronym
Genetic Polymorphisms Associated with ICI Efficacy in NSCLC
Region
| Japan |
Condition
Condition
Non-Small Cell Lung Cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the association between genetic polymorphisms and the clinical efficacy of immune checkpoint inhibitors in patients with non-small cell lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Overall Survival (OS)
2. Progression-Free Survival (PFS)
3. Objective Response Rate (ORR)
Key secondary outcomes
1. Incidence of Adverse Events
2. Quality of Life
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study is intended for patients who meet all of the following criteria.
1. Patients aged 18 years or older diagnosed with resectable non-small cell lung cancer (regardless of PD-L1 TPS value).
2. Patients scheduled to receive or who have received chemotherapy, including an immune checkpoint inhibitor (ICI), as neoadjuvant therapy.
3. Patients who have provided informed consent to participate in this study.
Key exclusion criteria
1. Under 18 years of age.
2. Has a condition for which immune checkpoint inhibitors are contraindicated.
3. Patients who do not provide informed consent to participate in this study.
4. Patients with a history of autoimmune diseases.
5. Patients who are currently taking immunosuppressive medications.
6. Any other patients deemed ineligible by their attending physician or the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Kawakami |
Organization
Hamamatsu University School of Medicine
Division name
Hospital Pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-435-2767
kojisuzu@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University School of Medicine
Division name
Hospital Pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-435-2767
Homepage URL
kojisuzu@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
Ethics Committee for Life Science and Medical Research, Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
Tel
053-435-2680
rinri@hama-med.ac.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 | 11 | Month | 13 | 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
| 2026 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2031 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Main endpoints of the observational study
Relevant genetic polymorphisms
Association between genetic polymorphisms and OS, PFS, and response rate
Management information
Registered date
| 2026 | Year | 11 | Month | 11 | Day |
Last modified on
| 2026 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072457
