UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057729 |
|---|---|
| Receipt number | R000065969 |
| Scientific Title | A multicenter prospective observational study investigating TARlatamab Guidance for Efficacy and Toxicity in patients with extensive disease small cell lung cancer |
| Date of disclosure of the study information | 2025/04/28 |
| Last modified on | 2025/04/28 10:32:35 |
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Basic information
Public title
A multicenter prospective observational study investigating TARlatamab Guidance for Efficacy and Toxicity in patients with extensive disease small cell lung cancer
Acronym
TARGET study
Scientific Title
A multicenter prospective observational study investigating TARlatamab Guidance for Efficacy and Toxicity in patients with extensive disease small cell lung cancer
Scientific Title:Acronym
TARGET study
Region
| Japan |
Condition
Condition
Extensive disease small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the anti-tumor effects and adverse events of tarlatamab in terms of peripheral blood T-cell subsets in patients with extensive disease small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anti-tumor effects and incidence of adverse events by peripheral blood mono-nuclear cell subset frequency 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
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients determined to have extensive disease small cell lung cancer
2. Patients with more than 2 treatment lines
3. Patients scheduled to receive tarlatamab
Key exclusion criteria
nothing in particular
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yujiro |
| Middle name | |
| Last name | Naito |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Respiratory Medicine and Clinical Immunology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita-city, Osaka
TEL
06-6879-3831
y.naito@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kinnosuke |
| Middle name | |
| Last name | Matsumoto |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Respiratory Medicine and Clinical Immunology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita-city, Osaka
TEL
06-6879-3831
Homepage URL
m.kinnosuke@gmail.com
Sponsor or person
Institute
Graduate School of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
None
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
Osaka University Institutional Review Board
Address
2-2, Yamadaoka, Suita-city, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
| 2025 | Year | 04 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular
Management information
Registered date
| 2025 | Year | 04 | Month | 28 | Day |
Last modified on
| 2025 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065969
