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    DRUG:

    Ameile (aumolertinib)

    i
    Company:
    Abdul Latif Jameel Health, Jiangsu Hansoh Pharma
    Drug class:
    EGFR inhibitor
    Related drugs:
    Apply
    PLATFORM Study of Precision Medicine for Rare Tumors (NCT04423185)
    Phase 2
    Cancer Institute and Hospital, Chinese Academy ...
    Recruiting
    Last update posted :
    02/11/2025
    Initiation :
    08/15/2020
    Primary completion :
    07/01/2026
    Completion :
    07/01/2028
    EGFR • HER-2 • BRAF • ALK • MET • BRCA1 • BRCA2 • KIT • ROS1 • CDKN2A
    |
    BRCA2 mutation • BRCA1 mutation • EGFR mutation • HER-2 overexpression • BRAF mutation • HER-2 amplification • MET amplification • KIT mutation • ALK fusion • ROS1 fusion • CDKN2A mutation • MET mutation • BRAF amplification
    |
    Xalkori (crizotinib) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • Zelboraf (vemurafenib) • imatinib • Tyvyt (sintilimab) • Alecensa (alectinib) • Zejula (niraparib) • Irene (pyrotinib) • Ameile (aumolertinib) • Vizimpro (dacomitinib)
    Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation (PIKACHU) (NCT04322890)
    Phase 2
    Hunan Province Tumor Hospital
    Recruiting
    Last update posted :
    06/04/2024
    Initiation :
    04/16/2020
    Primary completion :
    12/24/2026
    Completion :
    12/24/2027
    EGFR • BRAF • ALK • ROS1
    |
    EGFR mutation • ALK positive • ALK mutation • ROS1 positive • ROS1 mutation
    |
    cisplatin • Xalkori (crizotinib) • Tagrisso (osimertinib) • erlotinib • gefitinib • Rozlytrek (entrectinib) • Alecensa (alectinib) • Lorbrena (lorlatinib) • Zykadia (ceritinib) • pemetrexed • Alunbrig (brigatinib) • Gavreto (pralsetinib) • Ameile (aumolertinib) • Orpathys (savolitinib) • Ivesa (firmonertinib)
    Almonertinib as First-line Treatment in Patients With EGFR Mutations Positive in Advanced NSCLC With Brain Metastases (ACHIEVE) (NCT04808752)
    Phase 2
    Zhejiang Cancer Hospital
    Active, not recruiting
    Last update posted :
    04/22/2024
    Initiation :
    07/09/2021
    Primary completion :
    06/15/2024
    Completion :
    07/15/2024
    EGFR
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Ameile (aumolertinib)
    Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Non-small Cell Lung Cancer (LungMate-007) (NCT04685070)
    Phase 2
    Shanghai Pulmonary Hospital, Shanghai, China
    Active, not recruiting
    Last update posted :
    03/27/2024
    Initiation :
    12/14/2021
    Primary completion :
    12/31/2022
    Completion :
    12/31/2027
    EGFR
    |
    EGFR mutation
    |
    Ameile (aumolertinib)
    Neoadjuvant Aumolertinib in Patients With AI-diagnosed EGFR-mutant High-risk Pulmonary Ground-glass Opacity. (NCT05946460)
    Phase 2
    The First Affiliated Hospital of Guangzhou Medi...
    Recruiting
    Last update posted :
    02/06/2024
    Initiation :
    08/15/2023
    Primary completion :
    07/10/2025
    Completion :
    07/10/2025
    EGFR
    |
    EGFR mutation
    |
    Ameile (aumolertinib)
    RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations (NCT06185400)
    Phase 2
    Cancer Institute and Hospital, Chinese Academy ...
    Not yet recruiting
    Last update posted :
    12/29/2023
    Initiation :
    02/01/2024
    Primary completion :
    07/01/2025
    Completion :
    12/01/2026
    HER-2
    |
    Tagrisso (osimertinib) • Irene (pyrotinib) • Ameile (aumolertinib) • Aidixi (disitamab vedotin) • Ivesa (firmonertinib)
    Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC：Prospective Study (SELECT-2) (NCT04401059)
    Phase 4
    Tian Xie
    Recruiting
    Last update posted :
    12/27/2023
    Initiation :
    11/09/2020
    Primary completion :
    09/30/2025
    Completion :
    03/30/2026
    EGFR • ALK • TP53 • MSI • PTEN • STK11 • JAK2 • PBRM1 • JAK1 • MDM4 • POLD1
    |
    EGFR mutation • EGFR L858R • EGFR positive
    |
    Tagrisso (osimertinib) • erlotinib • gefitinib • Conmana (icotinib) • Ameile (aumolertinib) • Ivesa (firmonertinib)
    A Study of HS-10241 Combined With Almonertinib Versus Platinum-based Chemotherapy in Treatment of Advanced NSCLC With MET Amplification After Failure of EGFR-TKI Therapy (HS-10241-301) (NCT06110663)
    Phase 3
    Jiangsu Hansoh Pharmaceutical Co., Ltd.
    Not yet recruiting
    Last update posted :
    11/01/2023
    Initiation :
    12/30/2023
    Primary completion :
    12/30/2024
    Completion :
    02/28/2025
    MET
    |
    EGFR mutation • EGFR L858R • EGFR T790M • MET positive
    |
    cisplatin • carboplatin • pemetrexed • Ameile (aumolertinib) • HS-10241
    A Clinical Study of the Combination of Anlotinib and Aumolertinib in the First-line Treatment of Advanced NSCLC With EGFR 21L858R Mutation (NCT06102928)
    Phase N/A
    Kunming Medical University
    Recruiting
    Last update posted :
    10/26/2023
    Initiation :
    10/30/2023
    Primary completion :
    10/30/2026
    Completion :
    10/30/2026
    EGFR
    |
    EGFR mutation • EGFR L858R
    |
    Focus V (anlotinib) • Ameile (aumolertinib)
    Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cance (NCT06043973)
    Phase 3
    Qianfoshan Hospital
    Recruiting
    Last update posted :
    09/21/2023
    Initiation :
    09/01/2023
    Primary completion :
    09/01/2026
    Completion :
    06/30/2027
    EGFR • TP53
    |
    TP53 mutation • EGFR mutation
    |
    Focus V (anlotinib) • Ameile (aumolertinib)
    Radiotherapy Combined With Almonertinib for Stage III EGFR-Mutated Lung Cancer (NCT05994339)
    Phase 2/3
    Laibin People's Hospital
    Not yet recruiting
    Last update posted :
    08/29/2023
    Initiation :
    09/01/2023
    Primary completion :
    08/08/2025
    Completion :
    12/08/2025
    EGFR
    |
    EGFR mutation
    |
    Ameile (aumolertinib)
    Almonertinib in the First-line Treatment of Patients of NSCLC With Poor Performance Status (NCT05826483)
    Phase 1
    Guangzhou Institute of Respiratory Disease
    Recruiting
    Last update posted :
    04/24/2023
    Initiation :
    01/01/2022
    Primary completion :
    12/28/2024
    Completion :
    12/30/2024
    EGFR
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
    |
    Ameile (aumolertinib)
    Aumolertinib Combined Intrathecal Chemotherapy for Leptomeningeal Metastasis From EGFR-Mutated NSCLC and Prognostic Value of Dynamic Changes in cfDNA Profiles (NCT05810350)
    Phase 2
    Three Gorges Hospital of Chongqing University
    Recruiting
    Last update posted :
    04/13/2023
    Initiation :
    01/01/2023
    Primary completion :
    12/31/2024
    Completion :
    12/31/2024
    EGFR
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    pemetrexed • Ameile (aumolertinib)
    Armatinib Alone or in Combination With SRT for Brain Metastases EGFR-mutated Non-small Cell Lung Cancer (NCT05800223)
    Phase 3
    Shanghai Cancer Hospital, China
    Recruiting
    Last update posted :
    04/05/2023
    Initiation :
    01/01/2023
    Primary completion :
    12/01/2027
    Completion :
    12/01/2028
    EGFR
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Ameile (aumolertinib)
    Safety and Efficacy of Aumolertinib Combined With Anlotinib as 1st Line Treatment in Advanced Lung Cancer EGFR Mutation With TP53 Co-Mutation (NCT05778149)
    Phase 2
    Tianjin Medical University Cancer Institute and...
    Not yet recruiting
    Last update posted :
    03/21/2023
    Initiation :
    03/31/2023
    Primary completion :
    03/31/2025
    Completion :
    03/31/2027
    EGFR • TP53
    |
    TP53 mutation • EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Focus V (anlotinib) • Ameile (aumolertinib)
    Efficacy of SRT as Salvage Therapy in Patients With Brain Oligo-progression of EGFR-mutant Non-small Cell Lung Cancer After Failure of the Third-generation EGFR-TKIs (NCT04519983)
    Phase 2
    Shanghai Cancer Hospital, China
    Recruiting
    Last update posted :
    03/20/2023
    Initiation :
    01/01/2022
    Primary completion :
    12/01/2023
    Completion :
    12/15/2023
    EGFR
    |
    Tagrisso (osimertinib) • Ameile (aumolertinib)
    Clinical Study of Ametinib Combined With Bevacizumab in First-line Treatment of Advanced NSCLC With EGFR-mutations. (NCT05754736)
    Phase 2
    The Second Affiliated Hospital of Shandong Firs...
    Recruiting
    Last update posted :
    03/06/2023
    Initiation :
    12/01/2022
    Primary completion :
    12/01/2023
    Completion :
    12/01/2025
    EGFR
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Avastin (bevacizumab) • Ameile (aumolertinib)
    Study of HS-10241 in Combination With Almonertinib in Patients With Locally Advanced or Metastatic NSCLC (NCT05430386)
    Phase 1
    Jiangsu Hansoh Pharmaceutical Co., Ltd.
    Recruiting
    Last update posted :
    02/14/2023
    Initiation :
    01/05/2022
    Primary completion :
    12/31/2023
    Completion :
    12/31/2023
    MET
    |
    EGFR L858R • EGFR exon 19 deletion • MET mutation • MET positive • EGFR T790M negative • EGFR mutation + MET-CEP7 fusion • MET positive + EGFR mutation
    |
    Ameile (aumolertinib) • HS-10241
    Envafolimab Immunotherapy After ctDNA EGFR Clearance by Treatment With Almonertinib in EGFR-Mutant, PD-LI Positive NSCLC (NCT05534113)
    Phase 2
    The First Affiliated Hospital with Nanjing Medi...
    Not yet recruiting
    Last update posted :
    09/14/2022
    Initiation :
    12/01/2022
    Primary completion :
    06/01/2025
    Completion :
    06/01/2025
    EGFR • PD-L1
    |
    PD-L1 expression • EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Ameile (aumolertinib) • Enweida (envafolimab)
    Almonertinib Plus Microwave Ablation in Advanced Non-small Cell Lung Cancer (MWA) (NCT04755738)
    Phase 2
    Qianfoshan Hospital
    Not yet recruiting
    Last update posted :
    09/06/2021
    Initiation :
    01/01/2022
    Primary completion :
    03/31/2023
    Completion :
    03/31/2025
    EGFR
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Ameile (aumolertinib)
    A Dose Exploration Study of Almonertinib for EGFRm NSCLC Patients With Brain/Leptomeningeal Metastasis (ARTISTRY) (NCT04778800)
    Phase N/A
    Henan Cancer Hospital
    Recruiting
    Last update posted :
    08/31/2021
    Initiation :
    03/20/2021
    Primary completion :
    02/20/2023
    Completion :
    02/20/2024
    EGFR
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Ameile (aumolertinib)
    the Efficacy and Safety of Anlotinib Combined With Almonertinib in the First-line Treatment of Patients With Brain Metastases From EGFR Mutation-positive Non-small Cell Lung Cancer (GASTO 1063) (NCT04978753)
    Phase 2
    Li-kun Chen
    Recruiting
    Last update posted :
    07/27/2021
    Initiation :
    05/01/2021
    Primary completion :
    05/30/2022
    Completion :
    12/30/2023
    EGFR
    |
    EGFR mutation
    |
    Focus V (anlotinib) • Ameile (aumolertinib)
    A Phase III Study to Assess the Efficacy and Safety of Almonertinib Versus Platinum-based Chemotherapy as First-line Therapy in Patients With Locally Advanced or Metastatic NSCLC Harbouring Uncommon EGFR Mutation (NCT04951648)
    Phase 3
    Jiangsu Hansoh Pharmaceutical Co., Ltd.
    Not yet recruiting
    Last update posted :
    07/07/2021
    Initiation :
    07/15/2021
    Primary completion :
    10/04/2023
    Completion :
    09/06/2024
    EGFR
    |
    EGFR mutation • EGFR L861Q • EGFR G719X • EGFR S768I
    |
    cisplatin • carboplatin • Ameile (aumolertinib)
    Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC (NCT04952168)
    Phase 2
    Yuan Chen
    Recruiting
    Last update posted :
    07/07/2021
    Initiation :
    06/02/2021
    Primary completion :
    06/02/2022
    Completion :
    06/02/2023
    EGFR
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Ameile (aumolertinib)
    Almonertinib With Bevacizumab for EGFR-Mutant NSCLC Patients With Leptomeningeal Metastasis (ATTRACT) (NCT04944069)
    Phase N/A
    Second Affiliated Hospital of Nanchang University
    Not yet recruiting
    Last update posted :
    06/29/2021
    Initiation :
    07/01/2021
    Primary completion :
    03/01/2024
    Completion :
    03/01/2025
    EGFR
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Avastin (bevacizumab) • Ameile (aumolertinib)
    Almonertinib Combined With Cerebral Radiation Treat Brain Metastases From EGFR Positive NSCLC (NCT04905550)
    Phase 2
    Chongqing University Cancer Hospital
    Recruiting
    Last update posted :
    06/02/2021
    Initiation :
    03/01/2021
    Primary completion :
    03/01/2024
    Completion :
    08/01/2024
    EGFR
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
    |
    Ameile (aumolertinib)
    Almonertinib Treats Advanced NSCLC Patients With EGFR Mutations Who Are Safety Intolerant After Osimertinib Treatment (ACTIVE) (NCT04882345)
    Phase 2
    Shanghai Chest Hospital
    Not yet recruiting
    Last update posted :
    05/11/2021
    Initiation :
    07/15/2021
    Primary completion :
    01/15/2024
    Completion :
    01/15/2024
    EGFR
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Tagrisso (osimertinib) • Ameile (aumolertinib)
    Almonertinib Versus Osimertinib in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases (ATTACK) (NCT04870190)
    Phase 3
    Shanghai Chest Hospital
    Not yet recruiting
    Last update posted :
    05/03/2021
    Initiation :
    06/01/2021
    Primary completion :
    06/01/2024
    Completion :
    06/01/2024
    EGFR
    |
    EGFR mutation • EGFR T790M • EGFR positive
    |
    Tagrisso (osimertinib) • Ameile (aumolertinib)
    Almonertinib for Advanced NSCLC Patients With Rare Mutations in EGFR (NCT04785742)
    Phase 2
    Sun Yat-sen University
    Enrolling by invitation
    Last update posted :
    03/08/2021
    Initiation :
    12/31/2020
    Primary completion :
    12/31/2023
    Completion :
    12/31/2023
    EGFR
    |
    EGFR mutation • EGFR L858R • EGFR positive
    |
    Ameile (aumolertinib)
    Almonertinib Combined With Pyrotinib in the Treatment of Advanced NSCLC Patients With HER-2 Amplification/Mutation After EGFR-TKI Resistance (APPEAR) (NCT04785729)
    Phase 2
    Sun Yat-sen University
    Recruiting
    Last update posted :
    03/08/2021
    Initiation :
    12/31/2020
    Primary completion :
    12/01/2023
    Completion :
    12/01/2023
    EGFR • HER-2
    |
    EGFR mutation • HER-2 amplification • EGFR L858R • HER-2 mutation • EGFR T790M
    |
    Irene (pyrotinib) • Ameile (aumolertinib)
    A Phase 2 Trial of Almonertinib With Concurrent Radiotherapy in The Treatment of Local Advanced EGFR-mutant NSCLC (NCT04636593)
    Phase 2
    First People's Hospital of Hangzhou
    Recruiting
    Last update posted :
    01/12/2021
    Initiation :
    08/01/2020
    Primary completion :
    12/31/2021
    Completion :
    12/31/2022
    EGFR
    |
    EGFR L858R • EGFR exon 19 deletion
    |
    Ameile (aumolertinib)
    Almonertinib as Upfront Treatment for Uncommon EGFR Mutation Harboring Non-Small-Cell Lung Cancer Patients: A Multicenter, Open-Label, Phase II Trial (AUTUMN) (NCT04553887)
    Phase 2
    Tianjin Medical University Cancer Institute and...
    Not yet recruiting
    Last update posted :
    10/13/2020
    Initiation :
    11/01/2020
    Primary completion :
    05/01/2023
    Completion :
    05/01/2023
    EGFR
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Ameile (aumolertinib)
    Almonertinib Vs. Erlotinib/Chemotherapy for Neo-adjuVant Treatment of Stage IIIA-N2 EGFR-mutated NSCLC (ANSWER) (NCT04455594)
    Phase 2
    The First Affiliated Hospital of Guangzhou Medi...
    Not yet recruiting
    Last update posted :
    07/02/2020
    Initiation :
    10/01/2020
    Primary completion :
    01/01/2023
    Completion :
    10/01/2025
    EGFR
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    cisplatin • erlotinib • carboplatin • pemetrexed • Ameile (aumolertinib)