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

NCT05662813 | Unknown Phase 2

• 1 other identifier: 2022 Annual Review No.746
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer

Keywords

EGFR; NSCLC; abnormal liver function; hepatopathy

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  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.

  24 months.

Secondary Outcomes (4)

• Liver Safety

  From the screening period to 28 days after treatment completion.

• Progression-free survival

  24 months.

• Disease control rate

  24 months.

• Overall survival

  From baseline until death due to any cause,up to a maximum of approximately 4 years.

Study Arms (1)

Almonertinib

EXPERIMENTAL

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

Drug: Almonertinib

Interventions

Almonertinib DRUG

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

Also known as: HS-10296

Almonertinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at least 18 years.
• Locally advanced (IIIB and IIIC) or metastatic (IV) NSCLC.
• Tumor tissue samples or blood samples are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R, both alone or coexist with other EGFR mutations).
• Patients have been treated with one kind of EGFR-TKIs and suffered from drug-induced liver injury, and have stopped EGFR-TKIs treatment before enrollment; or patients with basic hepatopathy (alcoholic liver disease, viral liver disease, metabolism related fatty liver disease, autoimmune liver disease, genetic metabolic liver disease), and patients can be treated with EGFR-TKIs after medical specialist evaluation, and no longger treated with hepatoprotective drugs (anti-inflammatory drugs, liver cell membrane repair protective agents, detoxification drugs, antioxidant drugs, cholagogic drugs) for 4 weeks before enrollment.
• ALT and AST ≤ 3 ULN, Child-Pugh grade A or B (≤ 9 points), and maintained for 4 weeks before enrollment (liver function evaluation criteria according to CTCAE 5.0) .
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3, and has not deteriorated at least 2 weeks, and the expected survival period is not less than 12 weeks.
• According to RECIST1.1, the patient has at least one intracranial target lesion and one extracranial target lesion. The requirements for target lesions are: measurable lesions that have not undergone local treatment such as irradiation or have clearly progressed after local treatment, with the longest diameter at baseline ≥10 mm (if it is a lymph node, the maximum short diameter is required to be ≥15 mm).

You may not qualify if:

• As judged by the investigator, patients with any serious or poorly controlled systemic diseases, such as poorly controlled hypertension, active bleeding-prone constitution, or active infection.
• Patients with any other malignant tumor in the past 5 years.
• Patients with prior drug-induced liver injury other than EGFR-TKIs.
• Patients with refractory nausea, vomiting or chronic gastrointestinal diseases, cannot swallow the study drug or who have received extensive intestinal resection, may affect the full absorption of Almonertinib.
• A history of interstitial lung disease, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease.
• Before Almonertinib treatment, patients with unresolved residual toxicity from previous anti-tumor therapy greater than CTCAE level 3, except for hair loss.
• Meet any of the following cardiac examination results:
• The average value of QT interval (QTcF) corrected by Fridericia's formula obtained from 3 ECG examinations at rest\> 470 msec;
• Resting ECG suggests that there are various clinically significant rhythms, conduction or ECG morphological abnormalities that are judged by the investigator (such as complete left bundle branch block, 3 degree atrioventricular block, 2 degree atrium Ventricular block and PR interval\> 250 msec, etc.);
• There are any factors that increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death or prolonged QT of immediate family members under 40 Any concomitant drugs in the interval;
• Left ventricular ejection fraction (LVEF) \<50%.
• Insufficient bone marrow reserve or organ function, reaching any one of the following laboratory limits (no corrective treatment within 1 week before laboratory examination of blood draw):
• Absolute neutrophil count \<1.5×109 / L;
• Platelet count \<100×109 / L;
• Hemoglobin \<90 g/L (\<9 g/dL);

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital，Sichuan University

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Liver Diseases; Digestive System Diseases

Interventions

aumolertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Feng Luo

  West China Hospital

  STUDY CHAIR

• Yanyang Liu

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Zhixi Li

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Jiewie Liu

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Li Wang

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Jiantao Wang

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Luo, doctor

CONTACT

18980601766; hxluofeng@163.com

Yanyang Liu

CONTACT

13668284452; lyy3346@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Chair

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 23, 2022
• Study Start: November 9, 2022
• Primary Completion: December 30, 2023
• Study Completion: June 30, 2025
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)