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

Sun Yat-sen University · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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safety
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)
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