Treatment resistance mechanism including TP53 mutation in untreated advanced or recurrent non-small cell lung cancer with EGFR L858R mutation. (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)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046441

Enrollment

230

Registered

2022-01-15

Start date

2022-01-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or recurrent non-small cell lung cancer with EGFR L858R mutation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results