UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033993 |
|---|---|
| Receipt number | R000038757 |
| Scientific Title | A retrospective study to investigate PD-L1 expression before and after EGFR-TKI therapy and its relationship with EGFR-TKI resistance mechanism in EGFR mutation-positive advanced recurrent non- squamous non-small-cell lung cancer |
| Date of disclosure of the study information | 2018/09/05 |
| Last modified on | 2022/09/07 09:50:18 |
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Basic information
Public title
A retrospective study to investigate PD-L1 expression before and after EGFR-TKI therapy and its relationship with EGFR-TKI resistance mechanism in EGFR mutation-positive advanced recurrent non- squamous non-small-cell lung cancer
Acronym
A retrospective study to investigate PD-L1 expression before and after EGFR-TKI therapy and its relationship with EGFR-TKI resistance mechanism in EGFR mutation-positive advanced recurrent non- squamous non-small-cell lung cancer
Scientific Title
A retrospective study to investigate PD-L1 expression before and after EGFR-TKI therapy and its relationship with EGFR-TKI resistance mechanism in EGFR mutation-positive advanced recurrent non- squamous non-small-cell lung cancer
Scientific Title:Acronym
A retrospective study to investigate PD-L1 expression before and after EGFR-TKI therapy and its relationship with EGFR-TKI resistance mechanism in EGFR mutation-positive advanced recurrent non- squamous non-small-cell lung cancer
Region
| Japan |
Condition
Condition
EGFR mutation-positive advanced recurrent non-squamous non-small-cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate changes in tumor immune microenvironment between before and after EGFR-TKI therapy by immunostaining in patients with EGFR mutation-positive advanced recurrent non-squamous non-small-cell lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes in PD-L1 expression level, CD73, TILs, and nonsynonymous mutation burden before and after EGFR-TKIs treatment
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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)Aged 20 years or older
2)Patients with pathologically confirmed non-squamous non-small-cell lung cancer
3)Patients at stage IIIB/IV (including those who had recurrence after definitive treatment such as surgery or radiotherapy)
4)Patients with confirmed EGFR mutation (any variant type)
5)Patients who were treated at Department of Medical Oncology, Kinki University Faculty of Medicine or a joint study institution
6)Patients whose tumor tissue at baseline available for this study
7)Patients who were confirmed to have disease progression during EGFR-TKI treatment and whose tumor tissues have been obtained at subsequent biopsy
8)As for the patients who received Osimertinib, T790M mutation must be detected during the previous conventional EGFR-TKIs
Key exclusion criteria
Not established
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Hayashi |
Organization
Kindai University, Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
Address
377-2 Ohno-higashi, Osaka-Sayama, 589-8511, Japan
TEL
072-366-0221
hidet31@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Haratani |
Organization
Kindai University, Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
Address
377-2 Ohno-higashi, Osaka-Sayama, 589-8511, Japan
TEL
072-366-0221
Homepage URL
haratani_k@med.kindai.ac.jp
Sponsor or person
Institute
Kindai university, Faculty of Medicine, Department of Medical Oncology
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
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
Address
Tel
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
近畿大学
神奈川県立循環器呼吸器病センター
倉敷中央病院
岸和田市民病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 05 | 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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will evaluate changes in tumor immune microenvironment, including PD-L1, CD73, TILs, and tumor mutation burden in the tumor tissues between before and after EGFR-TKI therapy by immunostaining and whole-exome sequencing in patients with EGFR mutation-positive advanced recurrent non-squamous non-small-cell lung cancer at Department of Medical Oncology, Kinki University Faculty of Medicine or a joint study institution.
Management information
Registered date
| 2018 | Year | 09 | Month | 02 | Day |
Last modified on
| 2022 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038757
| Research Plan | |
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| Registered date | File name |
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