Safety and Efficacy of Aumolertinib Combined With Anlotinib as 1st Line Treatment in Advanced Lung Cancer EGFR Mutation With TP53 Co-Mutation

NSCLC Clinical Trial

Official title: Safety and Efficacy of Aumolertinib Combined With Anlotinib as 1st Line Treatment in Advanced Lung Cancer EGFR Mutation With TP53 Co-Mutation

Status Not yet recruiting

Clinical Trial Summary

The goal of this open, single-arm, exploratory phase II clinical study is to exploratory safety and efficacy in 1st line treatment in advanced lung cancer EGFR mutation with TP53 co-mutation. 47 patients are scheduled to be enrolled. Treatment regimen is aumolertinib 110mg p.o QD and Anlotinib 12mg oral for 2 weeks, three weeks a cycle, until disease progression or intolerable adverse reactions or death.

Clinical Trial Description

The primary objective of this study was to explore the median PFS of aumolertinib Combined With anlotinib as first-line treatment in advanced lung cancer EGFR mutation with TP53 co-mutation.The secondary objective of this study was to evaluate the ORR, DCR, DOR, OS and safety of aumolertinib Combined With anlotinib as first-line treatment in advanced lung cancer EGFR mutation with TP53 co-mutation. In addition, we also try to explore predictive or prognostic biomarkers (tissue and/or plasma) related to disease treatment response or drug resistance. Analyze the potential biomarkers in the biopsy tissue samples and blood samples after the disease progresses, and explore the possible mechanism of treating drug resistance. ;

Related Conditions & MeSH terms

• Anlotinib
• EGFR Activating Mutation
• NSCLC
• TP53

• NCT number: NCT05778149
• Study type: Interventional
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Zhan sheng Jiang, Doctor
• Phone: 0086-022-23340123
• Email: zhjiang@tmu.edu.cn
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 31, 2023
• Completion date: March 31, 2027