UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037614 |
|---|---|
| Receipt number | R000042868 |
| Scientific Title | Early prediction of immune checkpoint inhibitor treatment efficacy in patients with untreated advanced non-small-cell lung cancer |
| Date of disclosure of the study information | 2019/08/07 |
| Last modified on | 2023/02/06 20:27:07 |
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Basic information
Public title
Early prediction of immune checkpoint inhibitor treatment efficacy in patients with untreated advanced non-small-cell lung cancer
Acronym
Early prediction of immune checkpoint inhibitor treatment efficacy in patients with untreated advanced non-small-cell lung cancer
Scientific Title
Early prediction of immune checkpoint inhibitor treatment efficacy in patients with untreated advanced non-small-cell lung cancer
Scientific Title:Acronym
Early prediction of immune checkpoint inhibitor treatment efficacy in patients with untreated advanced non-small-cell lung cancer
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To determine whether both FDG-PET/CT and liquid biopsy performed 6 week after the initiation of pembrolizumab can predict the treatment outcomes in patients with unresectable or advanced non-small cell cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the discriminative power of the change of SUVmax, which is obtained via PET/CT 6 week after the initiation of pembrolizumab treatment.
Key secondary outcomes
analysis using liquid biopsy
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
18F-FDG PET/CT and liquid biopsy are performed 6 week after initiation of therapy with pembrolizumab
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Previously untreated with chemotherapy
2. Patients more than 20 years old
3. Treated with pembrolizumab (combined with or without chemotherapy)
4. Appropriate physical status
5. Obtained informed consent
Key exclusion criteria
1. Small-cell carcinoma or unknown
2. Positive for EGFR mutation, ALK fusion, Ros-1 fusion, and BRAF mutation
3. Ever treated with chemotherapy or radiotherapy
4. Poor physical status
5. Severe complication
6. Fasting blood glucose over 150 mg/dl
7. Unable to perform 18F-FDG PET/CT or CT because of complications
8. Other inappropriate patients
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Takeuchi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Medical Oncology
Zip code
060-8638
Address
North 15 West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan
TEL
011-706-5551
stakeuch@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Takeuchi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Medical Oncology
Zip code
060-8638
Address
North 15 West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan
TEL
011-706-5551
Homepage URL
stakeuch@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Hokkaido University Hospital
Address
North 14 West 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
Tel
011-716-1161
stakeuch@med.hokudai.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
| 2019 | Year | 08 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2019 | Year | 08 | Month | 06 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042868
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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