UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039182 |
|---|---|
| Receipt number | R000044652 |
| Scientific Title | Multicenter prospective observational study to evaluate immune cell dynamics of EGFR tyrosine kinase inhibitor re-administration after administration of immune checkpoint inhibitor in patients with relapsed / advanced non-small cell lung cancer with EGFR gene mutation |
| Date of disclosure of the study information | 2020/01/17 |
| Last modified on | 2024/01/22 15:38:18 |
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Basic information
Public title
Multicenter prospective observational study to evaluate immune cell dynamics of EGFR tyrosine kinase inhibitor re-administration after administration of immune checkpoint inhibitor in patients with relapsed / advanced non-small cell lung cancer with EGFR gene mutation
Acronym
A multicenter prospective observational study to evaluate immune cell dynamics of EGFR-TKI re-administration after ICI
Scientific Title
Multicenter prospective observational study to evaluate immune cell dynamics of EGFR tyrosine kinase inhibitor re-administration after administration of immune checkpoint inhibitor in patients with relapsed / advanced non-small cell lung cancer with EGFR gene mutation
Scientific Title:Acronym
A multicenter prospective observational study to evaluate immune cell dynamics of EGFR-TKI re-administration after ICI
Region
| Japan |
Condition
Condition
relapsed / advanced non-small cell lung cancer with EGFR gene mutation
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of readministration of EGFR-TKI on the immune system in patients who became refractory to EGFR-TKI and cytotoxic anticancer drugs
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in immune cell dynamics by EGFR-TKI administration
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Definitive diagnosis of non-small cell lung cancer has been obtained histologically or cytologically.
2) Patients with unresectable advanced / postoperative recurrent cancer of clinical stage III / IV.
3) EGFR gene mutation is found in tissue or cell samples.
4) Refractory to at least one or more regimens of EGFR-TKI therapy and cytotoxic anticancer drugs.
5) The immune checkpoint inhibitor was administered immediately and was discontinued due to exacerbation of the disease or adverse events.
6) The attending physician has determined that re-administration of EGFR-TKI is appropriate and will administer it.
7) Age at the time of registration is 20 years or older.
8) Performance status (ECOG classification) is 0 ~ 1.
9) Blood samples can be provided.
10) At least 3 months survival is expected.
11) Consent is obtained in writing regarding participation in this study.
Key exclusion criteria
1) Patients with interstitial lung disease or a history of it.
2) HBs antigen positive.
3) HBs antibody or HBc antibody positive and HBV-DNA positive.
4) HCV carrier.
5) Serious complications.
6) A history of severe hypersensitivity.
7) The principal investigator or the research coordinator determined that participation in this study was inappropriate.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Takuma |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2263
Homepage URL
takuma@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine Ethics Review Committee
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
Tel
053-435-2680
rinri@hama-med.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
| 2020 | Year | 01 | Month | 17 | 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
| 2019 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood tests and clinical information will be obtained before registration, 4 weeks after administration, and at the end of treatment.
Management information
Registered date
| 2020 | Year | 01 | Month | 17 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044652
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
