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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046441
Receipt No. R000052819
Scientific Title Treatment resistance mechanism including TP53 mutation in untreated advanced or recurrent non-small cell lung cancer with EGFR L858R mutation. (WJOG14420LTR)
Date of disclosure of the study information 2022/01/15
Last modified on 2022/06/22

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Basic information
Public title Treatment resistance mechanism including TP53 mutation in untreated advanced or recurrent non-small cell lung cancer with EGFR L858R mutation. (WJOG14420LTR)
Acronym WJOG14420LTR
Scientific Title Treatment resistance mechanism including TP53 mutation in untreated advanced or recurrent non-small cell lung cancer with EGFR L858R mutation. (WJOG14420LTR)
Scientific Title:Acronym Resistance mechanisms including TP53 mutation in EGFR L858R-mutant non-small cell lung cancer. (WJOG14420LTR)
Region
Japan

Condition
Condition Advanced or recurrent non-small cell lung cancer with EGFR L858R mutation
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to conduct an exploratory study of the following in patients enrolled in WJOG14420L.
(1) To determine the efficacy of erlotinib plus ramucirumab compared with osimertinib in patients with TP53 mutation and EGFR mutation.
(2) To clarify the mechanism of resistance to EGFR-TKI using blood/tissue samples before initiation of therapy and after disease progression.
(3) To investigate the relationship between blood VEGF levels and resistance mechanisms.
(4) To investigate the difference in efficacy of erlotinib plus ramucirumab and osimertinib based on pre-treatment gene expression profile.
(5) To investigate the difference in gene expression before and after EGFR-TKI treatment.
(6) To compare the efficacy of erlotinib plus ramucirumab group and osimertinib monotherapy group according to the presence of T790M mutation in pretreatment samples by ddPCR.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The purpose of this study is to conduct an exploratory study of the following in patients enrolled in WJOG14420L.
(1) To determine the efficacy of erlotinib plus ramucirumab compared with osimertinib in patients with TP53 mutation and EGFR mutation.
(2) To clarify the mechanism of resistance to EGFR-TKI using blood/tissue samples before initiation of therapy and after disease progression.
(3) To investigate the relationship between blood VEGF levels and resistance mechanisms.
(4) To investigate the difference in efficacy of erlotinib plus ramucirumab and osimertinib based on pre-treatment gene expression profile.
(5) To investigate the difference in gene expression before and after EGFR-TKI treatment.
(6) To compare the efficacy of erlotinib plus ramucirumab group and osimertinib monotherapy group according to the presence of T790M mutation in pretreatment samples by ddPCR.
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 (a) Patients who have consented to participate in this translational research prior to the start of treatment.
(b) Patients in whom WJOG14420L study treatment has already been started and have given consent for this translational research.
(c) If WJOG14420L study treatment has already been initiated and it is difficult to obtain consent from the subject for some reason (death, hospital transfer, etc.), written or oral consent will not be obtained from the subject for this study. However, in order to give the subject or a substitute the opportunity to refuse to participate in this study, materials about opting out will be posted, and the data of the subject who requests refusal of participation in the study will be deleted from the analysis.
Key exclusion criteria none
Target sample size 230

Research contact person
Name of lead principal investigator
1st name Hidetoshi
Middle name
Last name Hayashi
Organization Kindai University Faculty of Medicine
Division name Department of Medical Oncology
Zip code 589-8511
Address 377-2, Onohigashi, Osaka-Sayama-shi, Osaka
TEL 072-366-0221
Email hidet31@med.kindai.ac.jp

Public contact
Name of contact person
1st name Shinichiro
Middle name
Last name Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code 556-0016
Address Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka, JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization Eli Lilly and Company, Ltd.
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 Kindai University Faculty of Medicine, Institutional Review Board
Address 377-2, Onohigashi, Osaka-Sayama-shi, Osaka
Tel 072-366-0221
Email zizen@med.kindai.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
2022 Year 01 Month 15 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 Enrolling by invitation
Date of protocol fixation
2021 Year 10 Month 29 Day
Date of IRB
2022 Year 01 Month 04 Day
Anticipated trial start date
2022 Year 01 Month 06 Day
Last follow-up date
2027 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information An observational study to investigate the correlation between TP53 mutation, gene expression, VEGF level and disease prognosis measured in residual samples (blood and tissue) from patients with EGFR gene L858R mutation-positive advanced or recurrent non-small cell lung cancer.

Management information
Registered date
2021 Year 12 Month 22 Day
Last modified on
2022 Year 06 Month 22 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052819

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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