UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062321 |
|---|---|
| Receipt number | R000071320 |
| Scientific Title | Exploratory Biomarker Study Accompanying an Investigator-Initiated Phase II Trial Evaluating the Efficacy and Safety of the PAI-1 Inhibitor TM5614 in Combination with Chemoradiotherapy Followed by Consolidation Therapy with an Immune Checkpoint Inhibitor for Locally Advanced Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2026/07/24 |
| Last modified on | 2026/07/23 18:25:44 |
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Basic information
Public title
A study to identify factors associated with the efficacy and adverse effects of treatment combining the PAI-1 inhibitor TM5614 with chemoradiotherapy and immunotherapy for locally advanced non-small cell lung cancer
Acronym
Study of Factors Associated with the Efficacy and Adverse Effects of TM5614 Combination Therapy
Scientific Title
Exploratory Biomarker Study Accompanying an Investigator-Initiated Phase II Trial Evaluating the Efficacy and Safety of the PAI-1 Inhibitor TM5614 in Combination with Chemoradiotherapy Followed by Consolidation Therapy with an Immune Checkpoint Inhibitor for Locally Advanced Non-Small Cell Lung Cancer
Scientific Title:Acronym
Exploratory Biomarker Study of TM5614 Combination Therapy
Region
| Japan |
Condition
Condition
Locally advanced non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
As an ancillary biomarker study of the investigator-initiated phase II trial entitled, A Phase II Investigator-Initiated Trial Evaluating the Efficacy and Safety of the PAI-1 Inhibitor TM5614 in Combination with Chemoradiotherapy Followed by Consolidation Therapy with an Immune Checkpoint Inhibitor for Locally Advanced Non-Small Cell Lung Cancer, this study will exploratorily investigate biomarkers that may enable the appropriate selection of patients for the investigational treatment, as well as mechanisms of treatment resistance.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In the investigator-initiated phase II trial evaluating the efficacy and safety of the PAI-1 inhibitor TM5614 in combination with chemoradiotherapy followed by consolidation therapy with an immune checkpoint inhibitor for locally advanced non-small cell lung cancer, the following analyses will be conducted: (1) plasma concentrations of proteins associated with treatment resistance and tumor immunity will be compared between patients who respond to treatment and those who do not; and (2) pretreatment intratumoral PAI-1 expression will be compared between responders and nonresponders.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients enrolled in the parent investigator-initiated phase II trial.
Patients who provide written informed consent to participate in this ancillary study before initiation of the study treatment.
Key exclusion criteria
Not applicable
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Masuda |
Organization
Hiroshima University Hospital
Division name
Department of Respiratory Medicine
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima
TEL
082-257-5196
ta-masuda@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Masuda |
Organization
Hiroshima University Hospital
Division name
Department of Respiratory Medicine
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima
TEL
0822575196
Homepage URL
ta-masuda@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
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
Hiroshima University Certified Review Board
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima
Tel
082-257-1551
iryo-sinsa@office.hiroshima-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
| 2026 | Year | 07 | Month | 24 | 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 | 10 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2026 | Year | 07 | Month | 23 | Day |
Last modified on
| 2026 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071320
