UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062715 |
|---|---|
| Receipt number | R000071733 |
| Scientific Title | Single-arm phase II study evaluating supportive therapy for patients with non-small cell lung cancer receiving immune checkpoint inhibitor plus chemotherapy using Juzentaihoto: SUPPORT-JTT study |
| Date of disclosure of the study information | 2026/08/27 |
| Last modified on | 2026/08/27 21:05:42 |
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Basic information
Public title
Single-arm phase II study evaluating supportive therapy for patients with non-small cell lung cancer receiving immune checkpoint inhibitor plus chemotherapy using Juzentaihoto: SUPPORT-JTT study
Acronym
Single-arm phase II study evaluating supportive therapy for patients with non-small cell lung cancer receiving immune checkpoint inhibitor plus chemotherapy using Juzentaihoto: SUPPORT-JTT study
Scientific Title
Single-arm phase II study evaluating supportive therapy for patients with non-small cell lung cancer receiving immune checkpoint inhibitor plus chemotherapy using Juzentaihoto: SUPPORT-JTT study
Scientific Title:Acronym
Single-arm phase II study evaluating supportive therapy for patients with non-small cell lung cancer receiving immune checkpoint inhibitor plus chemotherapy using Juzentaihoto: SUPPORT-JTT study
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to evaluate the efficacy of Juzentaihoto in reducing adverse event and improvement the efficacy of chemoimmunotherapy for non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue and quality of life
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administering Juzentaihoto to patients with non-small cell lung cancer planned to receive chemoimmunotherapy.
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. Patients diagnosed with non-squamous non-small cell lung cancer based on histopathological examination
2. Patients with a performance status of 0-1 at the time of enrollment
3. Patients that were determined during the enrollment period to be clinically eligible for initial systemic treatment with pembrolizumab+carboplatin+pemetrexed at Toyama University Hospital or Toyama Prefectural Central Hospital
4. Patients presenting with any of the following symptoms; weakness, fatigue, loss of appetite, night sweats, cold hands and feet, or anemia, for which JuzenTaiho is covered by health insurance in Japan
Key exclusion criteria
1. Patients under 20 years of age
2. Patients who are positive for either an EGFR gene mutation or an ALK fusion gene
3. Patients presenting with Grade 1 or higher hypokalemia (eligible after correction)
4. Patients presenting with Grade 2 or higher elevations in AST, ALT, or Cre
5. Patients presenting with Grade 3 or higher loss of appetite
6. Patients with Grade 3 or higher hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg)
7. Patients with an autoimmune disease
8. Patients with interstitial pneumonia (excluding radiation pneumonitis)
9. Patients receiving the treatment with steroids equivalent to prednisolone of 5mg/day.
10. Patients taking Kampo medicine (Patients for whom a 4-week washout period can be arranged are eligible)
11. Patients with a history of treatment with immune checkpoint inhibitors
12. Patients diagnosed with another malignancy within the past 5 years (excluding cases following curative resection or carcinoma in situ)
13. Patients deemed incapable of providing informed consent
14. Patients deemed inappropriate for trial participation by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mosaburo |
| Middle name | |
| Last name | Kainuma |
Organization
University of Toyama
Division name
Department of Japanese Oriental Medicine
Zip code
930-0194
Address
Sugitani 2630, Toyama city
TEL
076-434-7393
kainuma@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Minehiko |
| Middle name | |
| Last name | Inomata |
Organization
University of Toyama
Division name
First Depertment of Internal Medicine
Zip code
930-0194
Address
Sugitani 2630, Toyama city
TEL
076-434-7287
Homepage URL
minomata@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, University of Toyama
Address
Sugitani 2630, Toyama city
Tel
076-415-8857
kenrinri@adm.u-toyama.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 | 08 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 27 | Day |
Last modified on
| 2026 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071733
