Unique ID issued by UMIN | UMIN000046441 |
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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 |
Treatment resistance mechanism including TP53 mutation in untreated advanced or recurrent non-small cell lung cancer with EGFR L858R mutation. (WJOG14420LTR)
WJOG14420LTR
Treatment resistance mechanism including TP53 mutation in untreated advanced or recurrent non-small cell lung cancer with EGFR L858R mutation. (WJOG14420LTR)
Resistance mechanisms including TP53 mutation in EGFR L858R-mutant non-small cell lung cancer. (WJOG14420LTR)
Japan |
Advanced or recurrent non-small cell lung cancer with EGFR L858R mutation
Pneumology | Hematology and clinical oncology |
Malignancy
YES
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.
Efficacy
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.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
(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.
none
230
1st name | Hidetoshi |
Middle name | |
Last name | Hayashi |
Kindai University Faculty of Medicine
Department of Medical Oncology
589-8511
377-2, Onohigashi, Osaka-Sayama-shi, Osaka
072-366-0221
hidet31@med.kindai.ac.jp
1st name | Shinichiro |
Middle name | |
Last name | Nakamura |
West Japan Oncology Group
WJOG datacenter
556-0016
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka, JAPAN
06-6633-7400
datacenter@wjog.jp
West Japan Oncology Group
Eli Lilly and Company, Ltd.
Profit organization
Kindai University Faculty of Medicine, Institutional Review Board
377-2, Onohigashi, Osaka-Sayama-shi, Osaka
072-366-0221
zizen@med.kindai.ac.jp
NO
2022 | Year | 01 | Month | 15 | Day |
Unpublished
No longer recruiting
2021 | Year | 10 | Month | 29 | Day |
2022 | Year | 01 | Month | 04 | Day |
2022 | Year | 01 | Month | 06 | Day |
2027 | Year | 03 | Month | 01 | Day |
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.
2021 | Year | 12 | Month | 22 | Day |
2023 | Year | 12 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052819
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