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    DRUG:

    Ameile (aumolertinib)

    i
    Other names: HS-10296, HS 10296, EQ143, EQ-143, EQ 143, HS10296
    Company:
    Abdul Latif Jameel Health, Glenmark, Jiangsu Hansoh Pharma
    Drug class:
    EGFR inhibitor
    Related drugs:
    3d
    A study evaluating the efficacy and safety of aumolertinib mesylate as first-line therapy in patients with EGFR-mutated stage IIIB-IV non-squamous non-small cell lung cancer (NSCLC) complicated by chronic obstructive pulmonary disease (COPD) (ChiCTR2600117077)
    P=N/A, N=51, Not yet recruiting, Tianjin Chest Hospital; Tianjin Chest Hospital
    New trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Ameile (aumolertinib)
    3d
    Exploration of the Efficacy and Safety of metronomic chemotherapy with vinorelbine capsules combined with third-generation EGFR-TKI as First-Line Treatment in Elderly Patients with Advanced Non-Small Cell Lung Cancer with EGFR Mutations (ChiCTR2500115674)
    P=N/A, N=66, Not yet recruiting, Beijing hospital; Beijing hospital
    New trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Tagrisso (osimertinib) • Ameile (aumolertinib) • vinorelbine tartrate • Ivesa (firmonertinib) • simmitinib (SYHA1817)
    3d
    A Single-Arm, Open-Label Clinical Study of Aumolertinib Monotherapy as Long-Cycle Neoadjuvant Treatment for Stage IB-ⅢB EGFR-Positive Non-Small Cell Lung Cancer (ChiCTR2500115235)
    P=N/A, N=30, Not yet recruiting, The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University
    New trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Ameile (aumolertinib)
    3d
    Exploration of the Exposure Level of Aumolertinib and Its Correlation with Clinical Efficacy in Patients with Lung Cancer (ChiCTR2500114329)
    P=N/A, N=50, Not yet recruiting, Shanghai General Hospital; Shanghai General Hospital
    New trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Ameile (aumolertinib)
    3d
    Exploratory clinical study on preserving organs in patients with stage II-III non-small cell lung cancer(The Future Star) (ChiCTR2500115167)
    P4, N=598, Recruiting, Jiangsu Cancer Hospital; Jiangsu Cancer Hospital
    New P4 trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • EGFR L858R • EGFR T790M • ALK mutation
    |
    carboplatin • albumin-bound paclitaxel • pemetrexed • Ensacove (ensartinib) • Ameile (aumolertinib) • AiRuiLi (adebrelimab)
    3d
    Almonertinib plus Anlotinib for EGFR Mutant NSCLC with Progression After Third-Generation TKI Adjuvant Therapy (ChiCTR2500114326)
    P4, N=50, Recruiting, Tianjin Medical University Cancer Institute&Hospital; Tianjin Medical University Cancer Institute&Hospital
    New P4 trial
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Focus V (anlotinib) • Ameile (aumolertinib)
    3d
    An Open-Label, Single-Arm, Exploratory Phase Ⅱ Clinical Study of Almonertinib Combined with Vinorelbine Tartrate Soft Capsules in the Treatment of Elderly Patients with Advanced NSCLC Progressed after Third-Generation EGFR-TKI Therapy (ChiCTR2600116503)
    P2, N=100, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital; Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Ameile (aumolertinib) • vinorelbine tartrate
    3d
    Prospective Phase II Single-Arm Study of Induction Therapy with Aumolertinib and Chemotherapy in Potentially Resectable Stage Ⅲ EGFR-Mutant Non-Squamous NSCLC (ChiCTR2600117161)
    P2, N=20, Not yet recruiting, Sichuan Cancer Hospital; Sichuan Cancer Hospital
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    carboplatin • pemetrexed • Ameile (aumolertinib)
    18d
    Aumolertinib as adjuvant therapy in resected EGFR-mutated non-small-cell lung cancer (ARTS): a double-blind, multicentre, randomised, controlled, phase 3 trial. (PubMed, Lancet Oncol)
    Aumolertinib showed substantial clinical benefits as adjuvant therapy in Chinese patients with stage II-IIIB EGFR-mutated NSCLC. The manageable safety profile of aumolertinib supports its suitability in the adjuvant setting.
    P3 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 19 deletion
    |
    Ameile (aumolertinib)
    25d
    A study protocol of a single-arm, prospective, open-label, non-controlled, phase II study of neoadjuvant BL-B01D1 combined with aumolertinib in resectable stage II-IIIB non-small cell lung cancer patients with EGFR mutation. (PubMed, Transl Lung Cancer Res)
    Registered on April 23, 2025. Protocol version: version 2.0, May 06, 2025.
    P2 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Ameile (aumolertinib) • izalontamab brengitecan (BL-B01D1)
    25d
    Individualized management strategies for advanced non-small cell lung cancer with EGFR exon 19 deletion and L861Q compound mutations based on circulating tumor DNA monitoring: A case report. (PubMed, Oncol Lett)
    The present case emphasized the importance of individualized management and the key role of ctDNA in real-time treatment monitoring, offering a potentially novel approach for precise disease evaluation in the future. Further research and the development of novel therapies are warranted to potentially improve outcomes in patients with advanced EGFR-mutated NSCLC.
    Journal • Circulating tumor DNA
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q
    |
    Ameile (aumolertinib)
    1m
    Case Report: Ivonescimab in EGFR-mutant lung cancer with baseline malignant pleural effusion and acquired complex resistance. (PubMed, Front Immunol)
    The patient eventually developed resistance to both first-line gefitinib and later almonertinib...He received ivonescimab monotherapy, achieving disease control for nearly 5 months before transitioning to ivonescimab plus pemetrexed with continued benefit and a manageable safety profile. This case illustrates the potential benefit of ivonescimab in patients with EGFR-mutant LUAD and baseline MPE who develop complex, non-canonical resistance to EGFR-TKIs. These findings support further clinical evaluation of ivonescimab in this poor-prognosis subgroup and highlight the importance of repeated molecular profiling in guiding treatment strategy.
    Journal • Pleural effusion • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • MET (MET proto-oncogene, receptor tyrosine kinase) • RB1 (RB Transcriptional Corepressor 1) • PD-1 (Programmed cell death 1) • SETD2 (SET Domain Containing 2, Histone Lysine Methyltransferase) • CHEK1 (Checkpoint kinase 1) • DNMT1 (DNA methyltransferase 1) • AKT2 (V-akt murine thymoma viral oncogene homolog 2)
    |
    PD-L1 expression • TP53 mutation • EGFR mutation • EGFR exon 19 deletion • MET amplification • EGFR T790M • CHEK1 mutation
    |
    gefitinib • pemetrexed • Ameile (aumolertinib) • Yidafan (ivonescimab)