Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Liver Diseases

Gastrointestinal Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

Almonertinib 110 mg，orally once a day. Patients receive Almonertinib treatment until disease progression, unacceptable toxicity or other discontinuation criteria.

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

Almonertinib

Feng Luo, doctor

Yanyang Liu

Feng Luo

Zhixi Li

Jiewie Liu

Li Wang

Jiantao Wang

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.

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.

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

ORR is defined as the number of patients with at least 1 visit response of CR (Complete response) or PR (Partial response) according to RECIST 1.1.

Liver function indicators, including ALT, AST, TBIL, D-BIL, I-BIL, ALP, GGT, bile acid, ALB, GLB.

PFS is defined as the time from date of enrollment until the date of disease progression as assessed according to RECIST 1.1 or death from any cause on study.

Disease control rate (DCR) is defined as the percentage of participants with disease control best overall response (complete response, partial response or stable disease).

OS is defined as time from date of enrollment until date of death due to any cause. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Almonertinib Therapy in Patients With Abnormal Liver Function After EGFR-TKI Treatment, or Almonertinib First-line Therapy in Patients With Basic Hepatopathy	NCT05662813	Non-small Cell ...	Almonertinib	18 Years -	West China Hospital
Almonertinib Therapy in Patients With Abnormal Liver Function After EGFR-TKI Treatment, or Almonertinib First-line Therapy in Patients With Basic Hepatopathy	NCT05662813	Non-small Cell ...	Almonertinib	18 Years -	West China Hospital

Spots Global Cancer Trial Database for abnormal liver function