UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063409 |
|---|---|
| Receipt number | R000072483 |
| Scientific Title | Exploration of Genetic Polymorphisms Associated with the Clinical Efficacy of Immune Checkpoint Inhibitors in Patients with Non-Small Cell Lung Cancer: A Prospective Observational Cohort Study |
| Date of disclosure of the study information | 2026/10/31 |
| Last modified on | 2026/10/27 21:51:44 |
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Basic information
Public title
Exploration of Genetic Polymorphisms Associated with the Clinical Efficacy of Immune Checkpoint Inhibitors in Patients with Non-Small Cell Lung Cancer: A Prospective Observational Cohort Study
Acronym
Exploration of Genetic Polymorphisms Associated with the Clinical Efficacy of Immune Checkpoint Inhibitors in Patients with Non-Small Cell Lung Cancer: A Prospective Observational Cohort Study
Scientific Title
Exploration of Genetic Polymorphisms Associated with the Clinical Efficacy of Immune Checkpoint Inhibitors in Patients with Non-Small Cell Lung Cancer: A Prospective Observational Cohort Study
Scientific Title:Acronym
Exploration of Genetic Polymorphisms Associated with the Clinical Efficacy of Immune Checkpoint Inhibitors in Patients with Non-Small Cell Lung Cancer: A Prospective Observational Cohort Study
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the association between cell death-related genetic polymorphisms and treatment outcomes in patients with non-small cell lung cancer receiving combination therapy with cytotoxic chemotherapy and immune checkpoint inhibitors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival (PFS)
Key secondary outcomes
Changes in circulating damage-associated molecular patterns (DAMPs) levels
Changes in circulating soluble immune checkpoint molecule levels
6-month disease control rate (DCR)
Incidence of adverse events
Overall survival (OS)
Changes in treatment regimen
Objective response rate (ORR)
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
[Cohort 1]
1. Patients aged 18 years or older diagnosed with unresectable advanced or recurrent non-small cell lung cancer (regardless of PD-L1 TPS value)
2. Patients scheduled to receive combination therapy with cytotoxic anticancer agents and immune checkpoint inhibitors (regardless of prior treatment history)
3. Patients who have provided informed consent to participate in this study
[Cohort 2]
1. Patients aged 18 years or older diagnosed with unresectable advanced or recurrent non-small cell lung cancer (regardless of PD-L1 TPS value)
2. Patients scheduled to receive immune checkpoint inhibitor therapy without cytotoxic chemotherapy (regardless of prior treatment history)
3. Patients who have provided informed consent to participate in this study
Key exclusion criteria
1. Patients who do not consent to participate in this study
2. Patients with a history of autoimmune disease
3. Patients receiving medications with immunosuppressive effect
4. Patients with an expected survival of less than 3 months
5. Patients deemed inappropriate by the attending physician or the principal investigator
Target sample size
40
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 | 10 | Month | 31 | 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 | 08 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design
Single-center prospective observational cohort study
Inclusion Criteria
[Cohort 1]
1. Patients aged 18 years or older diagnosed with unresectable advanced or recurrent non-small cell lung cancer (regardless of PD-L1 TPS value)
2. Patients scheduled to receive combination therapy with cytotoxic anticancer agents and immune checkpoint inhibitors (regardless of prior treatment history)
3. Patients who have provided informed consent to participate in this study
[Cohort 2]
1. Patients aged 18 years or older diagnosed with unresectable advanced or recurrent non-small cell lung cancer (regardless of PD-L1 TPS value)
2. Patients scheduled to receive immune checkpoint inhibitor therapy without cytotoxic chemotherapy (regardless of prior treatment history)
3. Patients who have provided informed consent to participate in this study
Exclusion criteria
1. Patients who do not consent to participate in this study
2. Patients with a history of autoimmune disease
3. Patients receiving medications with immunosuppressive effect
4. Patients with an expected survival of less than 3 months
5. Patients deemed inappropriate by the attending physician or the principal investigator
Primary outcomes
Progression-free survival (PFS)
Secondary outcomes
Changes in circulating damage-associated molecular patterns (DAMPs) levels
Changes in circulating soluble immune checkpoint molecule levels
6-month disease control rate (DCR)
Incidence of adverse events
Overall survival (OS)
Changes in treatment regimen
Objective response rate (ORR)
Association between outcome measures and genetic polymorphisms
The associations of the primary and secondary outcomes with NINJ1 genetic polymorphisms will be evaluated.
Management information
Registered date
| 2026 | Year | 10 | Month | 25 | Day |
Last modified on
| 2026 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072483
