NCT05778149

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Aumolertinib
• Anlotinib
• TP53
• NSCLC
• EGFR Activating Mutation

Interventions

Type	Name	Description
DRUG	Aumolertinib,Anlotinib	Aumolertinib 110mg p.o QD; Anlotinib 12mg, oral for 2 weeks, three weeks a cycle, until disease progression.

Timeline

• Start date: 2023-03-31
• Primary completion: 2025-03-31
• Completion: 2027-03-31
• First posted: 2023-03-21
• Last updated: 2023-03-21