UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046072 |
|---|---|
| Receipt number | R000052280 |
| Scientific Title | Exploratory observational study of the effects of EGFR-TKIs on NLRs |
| Date of disclosure of the study information | 2021/11/15 |
| Last modified on | 2024/11/19 13:26:57 |
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Basic information
Public title
Exploratory observational study of the effects of EGFR-TKIs on NLRs
Acronym
Exploratory observational study of the effects of EGFR-TKIs on NLRs
Scientific Title
Exploratory observational study of the effects of EGFR-TKIs on NLRs
Scientific Title:Acronym
Exploratory observational study of the effects of EGFR-TKIs on NLRs
Region
| Japan |
Condition
Condition
EGFR+ NSCLC
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to use EGFR-TKI in subjects who met the patient selection criteria among patients who started treatment with EGFR-TKI as a first-line drug for EGFR mutation-positive non-small cell lung cancer. To investigate the effects on NLR (neutrophil-lymphocyte ratio) and efficacy (tumor shrinkage effect (ORR) and progression-free survival (PFS)).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Relaiton of NLR and ORR/PFS
Key secondary outcomes
Relation of NLR and OS
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) NSCLC Adeno
2) Stage III/IV + After Ope
3) EGFR+ (Ex19del or L858R)
4) Locally Advanced or Metastatic Chemo Naive
5) Age>=20
6)PS:0-2
7) Not double cancer
8)Sufficient function(Liver,Kidney,CV)
9)EGFR-TKI started 2/1/2015-1/31/2020
Key exclusion criteria
Not Eligible
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroshige |
| Middle name | |
| Last name | Yoshioka |
Organization
Kansai Medical University
Division name
Department of Respiratory Oncology
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata
TEL
072-804-0101
hgyoshioka@gmail.com
Public contact
Name of contact person
| 1st name | Hiroshige |
| Middle name | Yoshioka |
| Last name | Yoshioka |
Organization
Kansai Medical University
Division name
Department of Respiratory Oncology
Zip code
573-1010
Address
2-5-1,Shinmachi,Hirakata
TEL
0728040101
Homepage URL
hgyoshioka@gmail.com
Sponsor or person
Institute
Kansai Medical University
Department of Respiratory Oncology
Institute
Department
Personal name
Funding Source
Organization
Delta-Fly Pharma Inc.
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
Kansai Medical University, Clinical Study Ethics Committee
Address
2-5-1,Shinmachi, Hirakata
Tel
0728040101
hgyoshioka@gmail.com
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
関西医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000052280
Publication of results
Published
Result
URL related to results and publications
Lung Cancer 62 (6) 634-634, 2022.
Number of participants that the trial has enrolled
153
Results
The study included 153 patients (10 facilities) with EGFR mutation-positive untreated advanced non-small cell lung cancer who had received initial treatment with afatinib or osimertinib. The cut-off value of NLR before the start of TKI was calculated to be 3.29 based on the ROC area with CR/PR as the objective variable, and a significant difference was found between the NLR value at 4-8 weeks and mOS, with a better prognosis in the NLR-decreasing group.
Results date posted
| 2024 | Year | 11 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 12 | Month | 01 | Day |
Baseline Characteristics
The study included 153 patients (10 institutions) with EGFR mutation-positive untreated advanced non-small cell lung cancer who were initially treated with afatinib or osimertinib. The median age was 70 years, and 66.7% were female. Brain metastasis was observed in 28.8% of patients.
Participant flow
The study retrospectively examined 153 patients (10 institutions) with EGFR gene mutation-positive, untreated advanced non-small cell lung cancer who were initially treated with afatinib or osimertinib.
Adverse events
Not applicable as this study was a non-intervention case.
Outcome measures
Change of NLR
n Ave SD Min Median Max vs.0W 0W-Delta vs.0W
Paired t Median Paired t
0W 153 3.65 2.39 0.61 3.12 15.41
1-2W 153 3.28 2.04 0.92 2.95 20.47 0.0624 -0.12 0.0624
4-8W 151 2.95 1.73 0.73 2.50 12.68 0.0006 -0.39 0.0007
12-16W 146 2.89 2.27 0.92 2.27 19.71 0.0058 -0.37 0.0115
36-48W 138 3.61 7.39 0.71 2.44 86.20 0.8759 -0.39 0.7269
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 11 | Month | 15 | Day |
Last modified on
| 2024 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052280
