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Clinical Trial Summary

This is a one-arm, observational, phase 2 clinical study . Patients with EGFR L858R mutation will be assigned to treatment group.The study includes the following stratification factors : sex (female/male), disease stage (stage IIIb vs. stage IV), and brain metastasis (yes vs. no).


Clinical Trial Description

This is a one-arm, observational, phase 2 clinical study . Patients with EGFR L858R mutation will be assigned to treatment group.The study includes the following stratification factors : sex (female/male), disease stage (stage IIIb vs. stage IV), and brain metastasis (yes vs. no). An independent review committee (IRC) will be used to determine the response based study endpoints. IRC membership and procedures will be detailed in an IRC charter. A data safety monitoring board (DSMB) will be used in this study. DSMB is an independent body and will be responsible for reviewing safety data of the study. DSMB membership and procedures will be detailed in a separate DSMB document. Information regarding the nature and the duration of subsequent treatment will be collected. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05263947
Study type Interventional
Source Tianjin Medical University Cancer Institute and Hospital
Contact zhansheng jiang, doctor
Phone 022-23340123-1101
Email zhjiang@tmu.edu.cn
Status Recruiting
Phase Phase 2
Start date August 30, 2021
Completion date December 30, 2023

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