Almonertinib, as a third-generation EGFR-TKI, has been used for the treatment of advanced non small cell lung cancer. How to improve the progression free survival in advance was a challenge. Our previous study showed that first-line EGFR-TKIs plus microwave ablation had PFS survival advantage versus EGFR-TKIs alone. So we conducted this prospective study to verify the efficacy and safety of the combination in a randomized, controlled, phase II clinical trial.
Almonertinib, as a third-generation EGFR-TKI, has been used for the treatment of advanced non small cell lung cancer. How to improve the progression free survival in advance was a challenge. Our previous study showed that first-line EGFR-TKIs plus microwave ablation had PFS survival advantage versus EGFR-TKIs alone. So we conducted this prospective study to verify the efficacy and safety of the combination in a randomized, controlled, phase II clinical trial. Patients were assigned into two groups.In the experiment group, patients were treated with both Almonertinib and microwave ablation. In the control group, patients were treated with Almonertinib alone. The primary end point was progression free survival. Second endpoints included overall survival and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
234
Patients were treated with almonertinib firstly.When almonertinib achieved the maximal response, microwave ablation was conducted on the primary lung tumors.
Xin Ye
Jinan, SD, China
PFS
progression free survival
Time frame: From the date of randomization to the date of disease progression or death for any causes,whichever came first, assessed up to 36 months.
OS
overall survival
Time frame: From the date of randomization to the date of death, assessed up to 36 months.
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