UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063575 |
|---|---|
| Receipt number | R000072754 |
| Scientific Title | Real-World Incidence and Risk Factors of TARLAtamab-Associated Pneumonitis: A Multicenter Retrospective AnalysIS Focusing on Comorbid Interstitial Pneumonia (TARLARIS) |
| Date of disclosure of the study information | 2026/11/10 |
| Last modified on | 2026/11/10 06:59:24 |
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Basic information
Public title
Real-World Incidence and Risk Factors of TARLAtamab-Associated Pneumonitis: A Multicenter Retrospective AnalysIS Focusing on Comorbid Interstitial Pneumonia
Acronym
Real-World Incidence and Risk Factors of TARLAtamab-Associated Pneumonitis: A Multicenter Retrospective AnalysIS Focusing on Comorbid Interstitial Pneumonia
Scientific Title
Real-World Incidence and Risk Factors of TARLAtamab-Associated Pneumonitis: A Multicenter Retrospective AnalysIS Focusing on Comorbid Interstitial Pneumonia (TARLARIS)
Scientific Title:Acronym
TARLARIS
Region
| Japan |
Condition
Condition
Small cell lung cancer previously treated with at least one regimen of chemotherapy, including a platinum doublet, who received tarlatamab in real-world clinical practice.
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the incidence and severity of tarlatamab-induced pneumonitis in real-world clinical practice in Japan
Basic objectives2
Others
Basic objectives -Others
Identification of risk factors
Risk stratification
Efficacy evaluation
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of all-grade tarlatamab-induced pneumonitis
Key secondary outcomes
Incidence of Grade 3 or higher tarlatamab-induced pneumonitis
Risk factors associated with the development of pneumonitis (e.g., smoking history, pre-existing lung abnormalities, and prior immune checkpoint inhibitor [ICI] therapy)
Efficacy of tarlatamab (objective response rate [ORR], disease control rate [DCR], progression-free survival [PFS], and overall survival [OS])
Incidence and severity of non-pneumonitis adverse events (cytokine release syndrome [CRS], immune effector cell-associated neurotoxicity syndrome [ICANS], and dysgeusia)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Pathologically confirmed small cell lung cancer (SCLC) by cytology or histology.
2. Meeting any of the following disease status criteria at the initiation of tarlatamab treatment:
a) Extensive-stage SCLC (ES-SCLC) at initial diagnosis.
b) Relapsed disease following curative-intent treatment (e.g., surgery or chemoradiotherapy) for limited-stage SCLC (LS-SCLC).
c) Disease clinically staged as LS-SCLC at initial diagnosis, for which systemic pharmacotherapy was selected in accordance with treatment strategies for ES-SCLC due to ineligibility for definitive thoracic radiotherapy (e.g., comorbid interstitial lung disease [ILD] or other medical reasons).
3. History of at least one prior chemotherapy regimen, including a platinum-based doublet.
4. Administration of tarlatamab as second-line or subsequent therapy in real-world clinical practice between April 16, 2025, and August 31, 2026.
Key exclusion criteria
Patients who were enrolled in an industry-sponsored clinical trial and received tarlatamab as an investigational treatment.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takayasu |
| Middle name | |
| Last name | Kurata |
Organization
Kansai Medical University
Division name
Department of Thoracic Oncology
Zip code
573-1191
Address
2-3-1 Shin-machi, Hirakata-city, Osaka, 573-1010, Japan
TEL
0728040101
kurata.tak@kmu.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Ikeda |
Organization
Kansai Medical University
Division name
Department of Thoracic Oncology
Zip code
573-1191
Address
2-5-1 Shin-machi, Hirakata-city, Osaka, 573-1010, Japan
TEL
072-804-0101
Homepage URL
isatoshi0112@gmail.com
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Research Ethics Committee of Kansai Medical University Hospital
Address
2-3-1 Shin-machi, Hirakata-city, Osaka, 573-1010, Japan
Tel
0728040101
ext-kotera.sac@kmu.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
関西医科大学附属病院（大阪府）
東邦大学医療センター大森病院（東京都）
JR札幌病院（北海道）
杏林大学医学部（東京都）
坪井病院（福島県）
沖縄県立中部病院（沖縄県）
京都大学医学部附属病院（京都府）
虎ノ門病院（東京都）
広島大学大学院 医系科学研究科（広島県）
国立国際医療センター（東京都）
済生会熊本病院（熊本県）
札幌医科大学附属病院（北海道）
産業医科大学（福岡県）
鹿児島大学病院（鹿児島県）
順天堂大学医学部附属順天堂医院（東京都）
神戸市立医療センター西市民病院（兵庫県）
神戸市立医療センター中央市民病院（兵庫県）
神奈川県立循環器呼吸器病センター（神奈川県）
長崎大学病院（長崎県）
天理よろづ相談所病院（奈良県）
東京科学大学病院（東京都）
東京慈恵会医科大学附属病院（東京都）
東北大学病院（宮城県）
藤田医科大学（愛知県）
徳島大学病院（徳島県）
日本医科大学付属病院（東京都）
浜松医科大学（静岡県）
富山大学（富山県）
福井大学医学部附属病院（福井県）
福岡大学筑紫病院（福岡県）
福岡大学病院（福岡県）
福島県立医科大学（福島県）
北海道大学病院（北海道）
名古屋大学医学部附属病院（愛知県）
獨協医科大学病院（栃木県）
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 10 | 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
| 2026 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter retrospective observational study
Target sample size 200 patients
Enrollment period 6 months
Analysis period 6 months
Total study duration 12 months
Management information
Registered date
| 2026 | Year | 11 | Month | 10 | Day |
Last modified on
| 2026 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072754
