NCT05662813

Almonertinib Therapy in Patients With Abnormal Liver Function After EGFR-TKI Treatment, or Almonertinib First-line Therapy in Patients With Basic Hepatopathy

a Phase II Studay to Assess the Efficacy and Safety of Almonertinib Therapy in Patients With Abnormal Liver Function After First/Second Generation TKI Treatment, or Almonertinib First-line Therapy in Patients With Basic Hepatopathy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of Almonertinib therapy in patients with abnormal liver function after first/second generation EGFR-TKI treatment, or Almonertinib first-line therapy in patients with basic hepatopathy and locally advanced or metastatic EGFR-mutant non-small cell lung cancer.

Detailed description

This is a single arm, open-lable, phase II clinical trial，aimed to assess the efficacy and safety of Almonertinib therapy in EGFR-mutant advanced non-small cell lung cancer patients with abnormal liver function after the first/second generation EGFR-TKI treatment or EGFR-mutant advanced non-small cell lung cancer patients with basic hepatopathy and have not received any systematic treatment. The patients meet all the inclusion criterias, and do not meet any exclusion criteria can be included, the duration of patient observation is 24 months.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Almonertinib	Almonertinib 110mg p.o qd. Patients receive Almonertinib treatment until disease progression, unacceptable toxicity or other discontinuation criteria.

Timeline

• Start date: 2022-11-09
• Primary completion: 2023-12-30
• Completion: 2025-06-30
• First posted: 2022-12-23
• Last updated: 2022-12-23

Locations

1 site across 1 country: China