UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057253 |
|---|---|
| Receipt number | R000065437 |
| Scientific Title | Multicenter Prospective Observational Study on the Efficacy and Safety of Tarlatamab in Relapsed Extended-stage Small-Cell Lung Cancer |
| Date of disclosure of the study information | 2025/04/23 |
| Last modified on | 2026/04/09 10:25:31 |
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Basic information
Public title
Multicenter Prospective Observational Study on the Efficacy and Safety of Tarlatamab in Relapsed Extended-stage Small-Cell Lung Cancer (T-REX study)
Acronym
Multicenter Prospective Observational Study on the Efficacy and Safety of Tarlatamab in Relapsed Extended-stage Small-Cell Lung Cancer (T-REX study)
Scientific Title
Multicenter Prospective Observational Study on the Efficacy and Safety of Tarlatamab in Relapsed Extended-stage Small-Cell Lung Cancer
Scientific Title:Acronym
Multicenter Prospective Observational Study on the Efficacy and Safety of Tarlatamab in Relapsed Extended-stage Small-Cell Lung Cancer
Region
| Japan |
Condition
Condition
Small Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to assess the real-world efficacy and safety of tarlatamab therapy in patients with recurrent small-cell lung cancer and to elucidate predictive factors for treatment outcomes and adverse events.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective response rate
Key secondary outcomes
Disease control rate, progression-free survival, time to treatment failure, overall survival, and safety of tarlatamab therapy; improvement in performance status
Efficacy and safety of tarlatamab therapy for central nervous system lesions
Association between the efficacy and safety of tarlatamab therapy and patient characteristics
Association between the efficacy and safety of tarlatamab therapy and cancer cachexia
Association between the efficacy and safety of tarlatamab therapy and the treatment line
Association between the efficacy and safety of tarlatamab therapy and eligibility for clinical trial criteria
Association of the efficacy and safety of tarlatamab therapy with gut microbiota composition and diversity, as well as tumor immune microenvironment factors
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
| 999 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Aged 18 years or older at the time of consent with a performance status of 0-3.
Recurrent small-cell lung cancer, regardless of the number of prior treatment lines.
At least one evaluable lesion according to RECIST version 1.1.
Scheduled to receive tarlatamab therapy.
Patients who have received a thorough explanation of this clinical study and have provided written informed consent voluntarily.
Key exclusion criteria
Patients deemed inappropriate by the attending physician.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Tadaaki |
| Middle name | |
| Last name | Yamada |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Graduate School of Medicine, Respiratory Medicine
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto City, Kyoto Prefecture, Japan
TEL
0752515513
tayamada@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Kawachi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Graduate School of Medicine, Respiratory Medicine,
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto City, Kyoto Prefecture, Japan
TEL
075-251-5513
Homepage URL
kwhat@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Hayato Kawachi
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine, Institutional Review Board
Address
465 Kajii-cho, Kamigyo-ku, Kyoto City, Kyoto Prefecture, Japan
Tel
0752515111
rinri@koto.kpu-m.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
京都府立医科大学附属病院(京都府)、宇治徳洲会病院(京都府)、大阪国際がんセンター(大阪府)、京都第一赤十字病院(京都府)、京都第二赤十字病院(京都府)、公益財団法人大原記念倉敷中央医療機構 倉敷中央病院(岡山県)、神戸低侵襲がん医療センター(兵庫県)、さいたま赤十字病院(埼玉県)、市立福知山市民病院(京都府)、聖マリアンナ医科大学病院(神奈川県)、手稲渓仁会病院(北海道)、徳島大学病院(徳島県)、函館五稜郭病院(北海道)、弘前大学医学部附属病院(青森県)、長崎大学病院(長崎県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 23 | 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
Collaborating Institutions:
Kyoto Prefectural University of Medicine Hospital, Uji Tokushukai Hospital, Osaka International Cancer Institute, Kyoto First Red Cross Hospital, Kyoto Second Red Cross Hospital, Kurashiki Central Hospital (Ohara Memorial Kurashiki Central Medical Organization), Kobe Minimally Invasive Cancer Center, Saitama Red Cross Hospital, Fukuchiyama City Hospital, St. Marianna University School of Medicine Hospital, Teine Keijinkai Hospital, Tokushima University Hospital, Hakodate Goryokaku Hospital, Hirosaki University School of Medicine and Hospital, Nagasaki University Hospital.
Management information
Registered date
| 2025 | Year | 03 | Month | 10 | Day |
Last modified on
| 2026 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065437
