Aumolertinib in EGFR-Mutant Resected Stage IB-IIIA NSCLC (AERESA).

Lung Cancer Clinical Trial

— AERESA  

Official title:

A Single-Arm, Open-Lable Study of Adjuvant Aumolertinib for Completely Resected Stage IB-IIIA Non-Small-Cell Lung Cancer With EGFR Exon 19 Deletion or L858R Mutations.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06227897
• Other study ID #: GASTO10109
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 1, 2024
• Est. completion date: April 1, 2029

Study information

• Verified date: February 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aumolertinib (almonertinib; HS-10296) is a novel third-generation EGFR-TKI showing activity against EGFR-sensitizing mutations and EGFR T790M mutation. The third-generation EGFR-TKI osimertinib has been approved in the adjuvant setting. This study is to studying 3-year aumolertinib as adjuvant therapy to see how well it works in treating patients with resected stage IB-IIIA NSCLC harboring sensitizing EGFR mutations.

Description:

Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced non-small cell lung cancer (NSCLC) with EGFR mutations. Aumolertinib (almonertinib; HS-10296) is a novel third-generation EGFR-TKI. Aumolertinib showed activity against EGFR-sensitizing mutations and EGFR T790M mutation. In the phase III AENEAS trial, aumolertinib had improved efficacy to gefitinib with similar safety. In the phase II APOLLO trial, aumolertinib is effective and well-tolerated for patients with advanced NSCLC having an EGFR T790M mutation after disease progression on first- and second-generation EGFR TKI therapy. The third-generation EGFR-TKI osimertinib has been approved in the adjuvant setting. This study is to studying 3-year aumolertinib as adjuvant therapy to see how well it works in treating patients with resected stage IB-IIIA NSCLC harboring sensitizing EGFR mutations.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 85
• Est. completion date: April 1, 2029
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Target population is high risk NSCLC with resection option for potential cure, as assessed by a faculty surgeon at SYSUCC. This may include clinical stage IB (=4cm), II and IIIA. Subjects with N3 nodal involvement are not included.

• Subjects should have a detected sensitizing EGFR.

• Written informed consent provided.

• Male and female, aged 18-75 years.

• Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

• Blood and specimens before and after treatment must be provided

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

• Life expectancy =12 weeks.

• EGFR activating mutation in exon 19 or 21.

• Adequate hematological function: Absolute neutrophil count (ANC) =2.0 x 109/L, and Platelet count =100 x 109/L, and Hemoglobin =9 g/dL (may be transfused to maintain or exceed this level).

• Adequate liver function: Total bilirubin = 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) = 2.5 x ULN in subjects without liver metastases; = 5 x ULN in subjects with liver metastases.

• Adequate renal function: Serum creatinine = 1.25 x ULN, or = 60 ml/min.

• Female subjects should not be pregnant or breast-feeding.

Exclusion Criteria:

• Known severe hypersensitivity to aumolertinib or any of the excipients of this product.

• Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).

• Evidence of clinically active interstitial lung disease.

• Eye inflammation not fully controlled or conditions predisposing the subject to this.

• Inability to comply with protocol or study procedures.

• A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.

• A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.

• History of another malignancy in the last 5 years with the exception of the following:

other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.

• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).

• Patient who has active serious infection (e.g. pyrexia of or 38.0? over)

• Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).

• Women who are pregnant or nursing.

• Ingredients mixed with small cell lung cancer patients.

• History of neurologic or psychiatric disorders.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Aumolertinib
Aumolertinib 110 mg per day orally for 3 years.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year Disease Free Survival	3-year DFS was defined as the proportion of patients who were disease free at 3 years.	3 years after the last patient is randomized
Secondary	Disease Free Survival	Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.	3 years
Secondary	Adverse Events	Adverse Events were monitored according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.	2 years after the last patient is randomized
Secondary	Number of participants with perioperative complications	Number of participants with perioperative complications	2 years
Secondary	3-year Overall Survival	3-year OS was defined as the proportion of patients who were alive at 3 years.	3 years after the last patient is randomized