NCT04755738

Almonertinib Plus Microwave Ablation in Advanced Non-small Cell Lung Cancer

Almonertinib Plus Microwave Ablation Versus Almonertinib in Previously Untreated，Advanced Non-small Cell Lung Cancer, a Randomized，Controlled，Phase II Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 234 (estimated)
• Sponsor: Qianfoshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced Non Small Cell Lung Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Almonertinib plus microwave ablation	Patients were treated with almonertinib firstly.When almonertinib achieved the maximal response, microwave ablation was conducted on the primary lung tumors.

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-03-31
• Completion: 2025-03-31
• First posted: 2021-02-16
• Last updated: 2021-09-05

Locations

1 site across 1 country: China