NCT04785729

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Safety

Interventions

Type	Name	Description
DRUG	Almonertinib combine with Pyrrolitinib	110mg,qd Almonertinib+（240mg/320mg/400mg）,qd Pyrrolitinib

Timeline

• Start date: 2020-12-31
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2021-03-08
• Last updated: 2021-03-08

Locations

1 site across 1 country: China