Spots Global Cancer Trial Database for Bevacizumab Combined With Double Dose Icotinib in Patients With EGFR Exon 21-L858R Mutation

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Trial Identification

Brief Title: Bevacizumab Combined With Double Dose Icotinib in Patients With EGFR Exon 21-L858R Mutation

Official Title: A One-arm, Observational, Phase 2 Clinical Study of Bevacizumab Combined With Double Dose Icotinib in Patients With EGFR Exon 21-L858R Mutant Advanced Non-squamous Non-small Cell Lung Cancer

Study ID: NCT05263947

Conditions

Carcinoma, Non-Small-Cell Lung

Bevacizumab

EGF-R Positive Non-Small Cell Lung Cancer

Tyrosine Kinase Inhibitor

Interventions

Bevacizumab and Icotinib

Study Description

Brief 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).

Detailed 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.