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    Association details:
    Biomarker:EGFR exon 19 deletion
    Cancer:Non Small Cell Lung Cancer
    Drug:Ameile (aumolertinib) (EGFR inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ESMO 2023
    Title:

    1328P - Analysis of data from the AENEAS study assessing the third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), aumolertinib, and virtual comparison with osimertinib

    Published date:
    10/16/2023
    Excerpt:
    Aumolertinib was superior in slowing g in tumors with Ex19del alterations compared to L858R mutations [p=0.0018], and superior to gefitinib in slowing g in tumors with Ex19del alterations [p<0.0001]…
    Trial ID:
    AENEAS
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    J Clin Oncol
    Title:

    AENEAS: A Randomized Phase III Trial of Aumolertinib Versus Gefitinib as First-Line Therapy for Locally Advanced or MetastaticNon–Small-Cell Lung Cancer With EGFR Exon 19 Deletion or L858R Mutations

    Published date:
    05/17/2022
    Excerpt:
    This double-blind phase III trial evaluated the efficacy and safety of aumolertinib compared with gefitinib as a first-line treatment for locally advanced or metastatic EGFR-mutated non–small-cell lung cancer...Among all patients with an EGFR exon 19 deletion mutation, the mPFS for the aumolertinib and gefitinib groups was 20.8 months and 12.3 months, respectively (HR, 0.39; P < .0001)…
    DOI:
    10.1200/JCO.21.02641
    Trial ID:
    AENEAS
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    J Clin Oncol
    Title:

    Randomized phase III trial of aumolertinib (HS-10296, Au) versus gefitinib (G) as first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and EGFR exon 19 del or L858R mutations (EGFRm)

    Published date:
    05/28/2021
    Excerpt:
    Pts with previously untreated metastatic or locally advanced NSCLC and EGFR exon 19 deletion or L858R were randomly assigned in a 1:1 ratio to receive either Au...Au significantly prolonged PFS and DoR compared to G as first-line therapy in pts with advanced NSCLC with EGFRm.
    DOI:
    10.1200/JCO.2021.39.15_suppl.9013
    Trial ID:
    AENEAS
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ASCO 2021
    Title:

    Randomized phase III trial of aumolertinib (HS-10296, Au) versus gefitinib (G) as first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and EGFR exon 19 del or L858R mutations (EGFRm)

    Published date:
    05/19/2021
    Excerpt:
    Pts with previously untreated metastatic or locally advanced NSCLC and EGFR exon 19 deletion or L858R were randomly assigned in a 1:1 ratio to receive either Au (110 mg once daily) or G (250 mg once daily)....Au significantly prolonged PFS (median 19.3 vs 9.9 months, HR 0.46, p-value <0.0001). DoR was also significantly prolonged with Au....Au significantly prolonged PFS and DoR compared to G as first-line therapy in pts with advanced NSCLC with EGFRm.
    DOI:
    10.1200/JCO.2021.39.15_suppl.9013
    Trial ID:
    AENEAS
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Almonertinib Plus Chemotherapy as First-line Treatment in Patients With EGFR Concomitant Non-EGFR Driver Gene Mutant, Locally Advanced or Metastatic NSCLC

    Excerpt:
    ...- The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), in combination with non-EGFR driver genes mutations assessed by central testing using tumour tissue sample....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A multicenter, open-label, single-arm clinical study of Aumolertinib mesylate as postoperative adjuvant treatment for patients with EGFRm positive stage IB and pure solid stage IA2-3 invasive Non-Small Cell Lung Cancer

    Excerpt:
    ...Patients with primary non-small cell lung cancer with 2 common EGFR mutations（EGFR 19 Del or 21 L858R）; 6. ...
    Trial ID:
    ChiCTR2200062887
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Phase II Trial of Upfront Radiotherapy Plus Almonertinib for Epidermal Growth Factor Receptor(EGFR)-Mutant Non-small-cell Lung Cancer(NSCLC) Patients With Brain Metastases

    Excerpt:
    ...EGFR-sensitive mutations (include 19del or L858R mutation or coexist with other types of EGFR mutation)....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Almonertinib Plus Chemotherapy as First-line Treatment in Patients With EGFR Concomitant Tumor Suppressor Gene Mutation

    Excerpt:
    ...- The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), in combination with tumor suppressor genes mutations assessed by central testing using tumour tissue sample....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Aumolertinib With Chemotherapy or Alone Compared With Osimertinib in Patients With Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer

    Excerpt:
    ...Tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity-ex19del or L858R-either alone or in combination with other EGFR mutations (eg, G719X, exon 20 insertions, S7681, L861Q) 4....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Aumolertinib With or Without Chemotherapy as 1st Line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Sensitizing EGFR Mutations

    Excerpt:
    ...The tumor harbors 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations assessed by central testing using tumor tissue sample or blood sample....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection

    Excerpt:
    ...Confirmation by the central laboratory that the tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Aumolertinib in Treatment of Resectable Stage IA EGFRm+ NSCLC: a Multi-center, Single-arm Clinical Trial

    Excerpt:
    ...Confirmation by the central laboratory that the tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Almonertinib vs. Erlotinib / Chemotherapy for Neo-Adjuvant Treatment of Stage IIIA-N2 EGFR-Mutated NSCLC: a Multicenter, Open-Label, Phase II Randomized Controlled Trial

    Excerpt:
    ......
    Trial ID:
    ChiCTR2000033677
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A prospective, open, randomized, controlled, multicenter trial of postoperative adjuvant chemoradical radiotherapy followed by sequential maintenance therapy with ametinib versus postoperative adjuvant chemoradical radiotherapy in patients with stage N2-III NSCLC with EGFR mutations

    Excerpt:
    ......
    Trial ID:
    ChiCTR2200057150
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Almonertinib With Chemotherapy in mEGFR NSCLC

    Excerpt:
    ...The tumor harbors 1 of the 2 common epidermal growth factor receptor (EGFR) mutations known to be associated with Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) sensitivity (Ex19del or L858R), either alone or in combination with other epidermal growth factor receptor (EGFR) mutations, which may include T790M....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Almonertinib as First-line Treatment in Patients With EGFR Mutations Positive in Advanced NSCLC With Brain Metastases

    Excerpt:
    ...Tumor tissue samples or blood samples are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R, both alone or coexist with other EGFR mutations)....
    Trial ID:
    ACHIEVE
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study to Evaluate Safety, PK and Efficacy of HS-10296 in Patients With NSCLC

    Excerpt:
    ...Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI, e.g., gefitinib or erlotinib....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study to Evaluate Safety and Efficacy of HS-10296 as First-Line Treatment in Patients

    Excerpt:
    ...The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either or in combination with other EGFR mutations assessed by central testing using tumour tissue sample or blood sample....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Almonertinib Therapy in Patients With Abnormal Liver Function After EGFR-TKI Treatment, or Almonertinib First-line Therapy in Patients With Basic Hepatopathy

    Excerpt:
    ...- Tumor tissue samples or blood samples are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R, both alone or coexist with other EGFR mutations)....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Almonertinib in the First-line Treatment of Patients of NSCLC With Poor Performance Status

    Excerpt:
    ...NSCLC patients with EGFR mutation (19 deletion/21 L858R point mutation) or primary T790M mutation in pre-enrollment genetic testing....
    Trial ID:
    NCT05826483
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Aumolertinib Combined Intrathecal Chemotherapy for Leptomeningeal Metastasis From EGFR-Mutated NSCLC and Prognostic Value of Dynamic Changes in cfDNA Profiles

    Excerpt:
    ...- Tumor tissue samples or blood samples were tested and confirmed as EGFR sensitive mutations (including exon 19 deletion or L858R, both alone or coexisting with other EGFR site mutations)....
    Trial ID:
    NCT05810350
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Armatinib Alone or in Combination With SRT for Brain Metastases EGFR-mutated Non-small Cell Lung Cancer

    Excerpt:
    ...epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation (alone or in combination with other EGFR mutations); 6....
    Trial ID:
    NCT05800223
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Phase III Study to Assess the Effects of Almonertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer

    Excerpt:
    ...The tumor harbours one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19Del, L858R), either alone or in combination with other EGFR mutations including T790M, assessed by cobas® EGFR Mutation Test (Roche Diagnostics) or Xiamen AmoyDx EGFR (ADx-ARMS, Super-ARMS method) kit in site or central laboratory....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Almonertinib Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB Non-Small Cell Lung Cancer With EGFR-sensitive Mutations

    Excerpt:
    ...Confirmation by the central laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Almonertinib Plus Microwave Ablation in Advanced Non-small Cell Lung Cancer

    Excerpt:
    ...EGFR Exon 19del or Exon 21 L858R mutations; 4....
    Trial ID:
    MWA
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Dose Exploration Study of Almonertinib for EGFRm NSCLC Patients With Brain/Leptomeningeal Metastasis (ARTISTRY)

    Excerpt:
    ...Tumor tissue samples or blood are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R) by ARMS; 6....
    Trial ID:
    ARTISTRY
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC

    Excerpt:
    ...Patients must has sensitizing EGFR mutation (e.g....
    Trial ID:
    NCT04952168
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Almonertinib Combined With Cerebral Radiation Treat Brain Metastases From EGFR Positive NSCLC

    Excerpt:
    ...Confirmed pathology of EGFR mutation positive（exon 19 deletion, L858R, T790M）NSCLC with brain metastases on enhanced MRI....
    Trial ID:
    NCT04905550
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Phase 2 Trial of Almonertinib With Concurrent Radiotherapy in The Treatment of Local Advanced EGFR-mutant NSCLC

    Excerpt:
    ...- Blood or tissue EGFR detection is Exon 19 deletion or L858R mutation;...
    Trial ID:
    NCT04636593
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Almonertinib as Upfront Treatment for Uncommon EGFR Mutation Harboring Non-Small-Cell Lung Cancer Patients: A Multicenter, Open-Label, Phase II Trial

    Excerpt:
    ...Cohort A: Patients with EGFR exon 20 insertion, failure of first-line standard chemotherapy, or intolerance to chemotherapy Cohort B: Patients with uncommen EGFR mutations but without exon 19 deletion, L858R, T790M, and exon 20 insertion 3....
    Trial ID:
    AUTUMN
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Almonertinib Vs. Erlotinib/Chemotherapy for Neo-adjuVant Treatment of Stage IIIA-N2 EGFR-mutated NSCLC

    Excerpt:
    ...Pathological complete response (pCR)`Major Pathological Response (MPR)`Disease free survival (DFS)`Overall Survival (OS)`R0 resection rate`Downstaging rate`Concordance of EGFRm status between plasma-derived ctDNA`Incidence of Adverse Events (AEs)...
    Trial ID:
    ANSWER
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Almonertinib Plus Radiotherapy compared with Concurrent RadioChemotherapy in the treatment of unresectable EGFR-mutated stage III Non-Small Cell Lung Cancer: a Multicenter, Open-Label, Randomized, Control Phase III Study

    Excerpt:
    ...Tumor tissue samples or blood samples of stage III NSCLC diagnosed as unresectable are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R, both alone or coexist with other EGFR mutations). ...
    Trial ID:
    ChiCTR2000040590
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A multicenter, open-label, single-arm clinical study of Aumolertinib mesylate as postoperative adjuvant treatment for patients with EGFRm positive stage IB and pure solid stage IA2-3 invasive non-small cell lung cancer

    Excerpt:
    ...The patient had a classical mutation of EGFR (EGFR 19 Del or 21 L858R) in primary non-small cell lung cancer; 6. ...
    Trial ID:
    ChiCTR2200063184
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    IASLC-WCLC 2023
    Title:

    Aumolertinib as Neoadjuvant Therapy for EGFR-mutated Non-Small Cell Lung Cancer: A Subcohort Analysis of the PURPOSE Trial

    Published date:
    08/08/2023
    Excerpt:
    Eligible patients with EGFR 19del were given Aumolertinib 110mg orally per day for 9 weeks followed by surgery, as one of the six cohorts in the PURPOSE trial….Remarkably, the ORR was 100%. Five patients received VATS lobectomy (83.3%) and one underwent open bi-lobectomy. All patients achieved R0 resection. Importantly, two patients achieved pCR (pCR rate 33.3%) (including one squamous cell carcinoma) and one achieved MPR (MPR rate 50%)....The subcohort analysis from the PURPOSE study has illustrated that Aumolertinib as neoadjuvant therapy is effective and feasible for locally-advanced EGFR 19del NSCLCs.
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    IASLC-WCLC 2022
    Title:

    EP08.02-003 - Aumolertinib Plus Chemotherapy as 1st Line Treatment in Advanced Lung Cancer EGFR Mutation and ctDNA Cleared Analysis

    Published date:
    07/12/2022
    Excerpt:
    We are conducting a phase II trial in untreated patients with advanced NSCLC EGFR-sensitizing mutation and performance status of 0 to 2….Patients are treated with aumolertinib 110mg orally perday plus pemetrexed 500mg/m2 and carboplatin...Preliminary overall ORR was 88.2% (30/34)...This is the first report that the combination of aumolertinib and chemotherapy provided a promising therapeutic strategy for advanced EGFR mutation NSCLC patients, even with CNS metastasis. And preliminary data from this trial suggests patients harboring EGFR exon19 deletion mutation and TP53 mutation would benefit more from this combination strategy (Table 1).
    Secondary therapy:
    carboplatin + pemetrexed
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Expert Opin Pharmacother
    Title:

    An evaluation of aumolertinib for the treatment of EGFR T790M mutation-positive non-small cell lung cancer

    Published date:
    03/10/2022
    Excerpt:
    In subgroup analysis, for patients with EGFR exon 19 deletion, ORR and DCR were 72.2% and 96.1% respectively, the median DoR was 15.1 months, the median PFS was 12.4 months, the median OS was NR (95% CI: NR-NR). For patients with EGFR L858R mutation, ORR and DCR were 63.5% and 89.4% respectively, the median DoR was 16.5 months, the median PFS was 12.3 months, the median OS was NR (95% CI: 22.9-NR).
    DOI:
    https://doi.org/10.1080/14656566.2022.2050213