UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046441
Receipt number 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 2023/12/15 10:30:29

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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 or person

Institute

West Japan Oncology Group

Institute

Department

Personal name



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

No longer recruiting

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

2023 Year 12 Month 15 Day



Link to view the page

Value
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