UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062128 |
|---|---|
| Receipt number | R000071078 |
| Scientific Title | Prospective Observational Study on Predictive Factors for the Onset and Severity of Cytokine Release Syndrome in Small Cell Lung Cancer Patients Treated with Tarlatamab |
| Date of disclosure of the study information | 2026/07/02 |
| Last modified on | 2026/07/02 23:06:25 |
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Basic information
Public title
Prospective Observational Study on Predictive Factors for the Onset and Severity of Cytokine Release Syndrome in Small Cell Lung Cancer Patients Treated with Tarlatamab
Acronym
A Prospective Study of Predictive Factors for CRS in Small Cell Lung Cancer Patients Treated with Tarlatamab
Scientific Title
Prospective Observational Study on Predictive Factors for the Onset and Severity of Cytokine Release Syndrome in Small Cell Lung Cancer Patients Treated with Tarlatamab
Scientific Title:Acronym
A Prospective Study of Predictive Factors for CRS in Small Cell Lung Cancer Patients Treated with Tarlatamab
Region
| Japan |
Condition
Condition
small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to identify predictive factors associated with the onset and severity of cytokine release syndrome (CRS) in small cell lung cancer patients treated with tarlatamab. A comprehensive analysis of 93 cytokines and clinical background factors will be conducted to explore a predictive model for CRS.
Basic objectives2
Others
Basic objectives -Others
This prospective observational study aims to identify cytokine and clinical background factors associated with the onset and severity of cytokine release syndrome (CRS) in small cell lung cancer patients treated with tarlatamab, and to explore a predictive model for CRS.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between cytokine levels and clinical background factors with the onset and severity of cytokine release syndrome (CRS) in patients treated with tarlatamab
Key secondary outcomes
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
1) Patients diagnosed with small cell lung cancer by histology or cytology
2) Patients with extensive-stage SCLC or relapsed limited-stage SCLC after prior treatment
3) Patients scheduled to receive tarlatamab between the date of approval and December 31, 2027
4) Aged 18 years or older at the time of consent
5) Provided written informed consent after receiving a full explanation of the study
Key exclusion criteria
1) Patients with a body temperature of 38 degrees Celsius or higher at the time of consent
2) Pregnant or breastfeeding patients
3) Patients deemed inappropriate for study participation by the principal or sub-investigator due to severe psychiatric disorders, communication difficulties, or inability to provide informed consent
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Shuhei |
| Middle name | |
| Last name | Teranishi |
Organization
Kanagawa Cancer Center
Division name
Department of Thoracic Oncology
Zip code
2418515
Address
2-3-2, Nakao, Yokohama Shi Asahi Ku, Kanagawa Ken
TEL
0455202222
teranishi.shu.su@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Shuhei |
| Middle name | |
| Last name | Teranishi |
Organization
Kanagawa Cancer Center
Division name
Department of Thoracic Oncology
Zip code
2418515
Address
2-3-2, Nakao, Yokohama Shi Asahi Ku, Kanagawa Ken
TEL
0455202222
Homepage URL
teranishi.shu.su@yokohama-cu.ac.jp
Sponsor or person
Institute
Kanagawa Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cancer Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Cancer Center
Address
2-3-2, Nakao, Yokohama Shi Asahi Ku, Kanagawa Ken
Tel
0455202222
clinical_trials@kcch.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 | 07 | Month | 02 | 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 | 11 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | 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
| 2026 | Year | 07 | Month | 02 | Day |
Last modified on
| 2026 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071078
