Clinical trial · Interventional
Aumolertinib in EGFR-Mutant Resected Stage IB-IIIA NSCLC (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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aumolertinib | Drug | Aumolertinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Aumolertinib
- description
- Aumolertinib 110 mg once daily (110 mg per day) orally for 36 months.
- interventionNames
- Drug: Aumolertinib
Primary outcomes (1)
- measure
- 3-year Disease Free Survival
- timeFrame
- 3 years after the last patient is randomized
- description
- 3-year DFS was defined as the proportion of patients who were disease free at 3 years.
Secondary outcomes (4)
- measure
- Disease Free Survival
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
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