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Almonertinib Combined With Pyrotinib in the Treatment of Advanced NSCLC Patients With HER-2 Amplification/Mutation After EGFR-TKI Resistance — APPEAR  

Safety Clinical Trial

Official title:
To Evaluate the Safety and Efficacy of Almonertinib Combined With Pyrotinib in the Treatment of Advanced NSCLC Patients With HER-2 Amplification/Mutation After EGFR-TKI Resistance: a Multicenter, Open-label Trial

Clinical Trial Summary

This is a multicenter, open, phase II clinical trial to evaluate the safety and efficacy of almonertinib combined with pyrrolitinib in locally advanced or metastatic NSCLC patients with her-2 variants detected after first-line EGFR-TKI treatment resistance. Patients with first-line EGFR-TKI resistance showed HER-2 variation (including mutation and amplification) in tissue or blood tests, and the treatment regimen of metinil combined with pyrrolitinib was performed to evaluate the safety and efficacy of the treatment regimen. To determine the optimal dose of pyrrolitinib, three dose groups of 240mg, 320mg, and 400mg were set, and the "3+3" study design principle was adopted. About 27-36 people will be included in the study (depending on the progress of the study)

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04785729
Study type Interventional
Source Sun Yat-sen University
Contact Feng Wen Fang, MD.
Phone +86-15322302066
Email fangwf@sysucc.org.cn
Status Recruiting
Phase Phase 2
Start date December 31, 2020
Completion date December 2023
View Details
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