UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057875 |
|---|---|
| Receipt number | R000066152 |
| Scientific Title | Clinical investigation of immunotherapeutic approaches for small cell lung cancer |
| Date of disclosure of the study information | 2025/05/26 |
| Last modified on | 2025/06/20 22:19:27 |
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Basic information
Public title
Predictive method for assessing the efficacy of tarlatamab
Acronym
Predictive method
Scientific Title
Clinical investigation of immunotherapeutic approaches for small cell lung cancer
Scientific Title:Acronym
Clinical investigation of immunotherapeutic approaches
Region
| Japan |
Condition
Condition
Small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The first objective is to evaluate the predictive validity of peripheral T cell cytotoxicity in determining the therapeutic efficacy of tarlatamab. The second objective is to assess the efficacy of tetracyclines in enhancing peripheral T cell cytotoxicity in vitro in patients undergoing tarlatamab treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between peripheral T cell cytotoxicity and the therapeutic efficacy of tarlatamab.
Key secondary outcomes
The efficacy of tetracyclines in enhancing peripheral T cell cytotoxicity.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pathologically diagnosed as small cell lung cancer.
Scheduled to undergo tarlatamab therapy.
Provided informed consent.
Key exclusion criteria
Deemed inappropriate by the attending physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Iwahori |
Organization
Osaka International Cancer Institute
Division name
Department of Cancer Immunotherapy
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka 541-8567 Japan
TEL
+81-6-6945-1181
kota.iwahori@oici.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Iwahori |
Organization
Osaka International Cancer Institute
Division name
Department of Cancer Immunotherapy
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka 541-8567 Japan
TEL
+81-6-6945-1181
Homepage URL
kota.iwahori@oici.jp
Sponsor or person
Institute
Osaka International Cancer Institute
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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Osaka International Cancer Institute
Address
3-1-69 Otemae, Chuo-ku, Osaka 541-8567 Japan
Tel
+81-6-6945-1181
rinri01@opho.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
| 2025 | Year | 05 | 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
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
| 2025 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The correlation between peripheral T cell cytotoxicity and the therapeutic efficacy of tarlatamab.
The efficacy of tetracyclines in enhancing peripheral T cell cytotoxicity.
Management information
Registered date
| 2025 | Year | 05 | Month | 15 | Day |
Last modified on
| 2025 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066152
