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

NCT06227897 | Withdrawn Phase 2 DMC

• 1 other identifier: GASTO10109
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Keywords

Lung cancer, EGFR, adjuvant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Disease Free Survival

  3 years

• Adverse Events

  2 years after the last patient is randomized

• Number of participants with perioperative complications

  2 years

• 3-year Overall Survival

  3 years after the last patient is randomized

Study Arms (1)

Aumolertinib

EXPERIMENTAL

Aumolertinib 110 mg once daily (110 mg per day) orally for 36 months.

Drug: Aumolertinib

Interventions

Aumolertinib DRUG

Aumolertinib 110 mg per day orally for 3 years.

Also known as: almonertinib, HS-10296

Aumolertinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Self-representation.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

aumolertinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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: Professor

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: June 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2029
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)