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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: Aumolertinib

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aumolertinib; Aumolertinib 110 mg once daily (110 mg per day) orally for 36 months.	Drug: Aumolertinib; Aumolertinib 110 mg per day orally for 3 years.; Other Names: HS-10296; almonertinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Free Survival	Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.	3 years
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
Number of participants with perioperative complications	Number of participants with perioperative complications	2 years
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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Lung cancer, EGFR, adjuvant
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: GASTO10109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No