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Association details:
| Biomarker: | EGFR L858R |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Ameile (aumolertinib) (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
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 EGFR L858R, the mPFS for the aumolertinib and gefitinib groups was 13.4 months and 8.3 months, respectively (HR, 0.60; P = .0102)…
DOI:
10.1200/JCO.21.02641
Trial ID:
Source:
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:
Source:
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:
Source:
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)....
Source:
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:
More C2 evidence
Source:
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....
Source:
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....
Source:
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....
Source:
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....
Source:
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:
Source:
Title:
A Study to Evaluate Safety, PK and Efficacy of HS-10296 in Patients With NSCLC
Excerpt:
...- Confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) OR must have experienced clinical benefit from EGFR TKI, according to the Jackman criteria (followed by systemic objective progression (RECIST or World Health Organization [WHO]) while on continuous treatment with an EGFR TKI....
Source:
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)....
Source:
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:
Source:
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:
Source:
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:
Source:
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....
Source:
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....
Source:
Title:
Almonertinib Plus Microwave Ablation in Advanced Non-small Cell Lung Cancer
Excerpt:
...EGFR Exon 19del or Exon 21 L858R mutations; 4....
Trial ID:
Source:
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:
Source:
Title:
Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC
Excerpt:
...exon 19 deletion or exon 21 L858R)....
Trial ID:
Source:
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:
Source:
Title:
Almonertinib for Advanced NSCLC Patients With Rare Mutations in EGFR
Excerpt:
...Positive EGFR driver mutation (rare mutation other than 19 exon deletion or L858R) detected by tumor tissue or blood samples....
Trial ID:
Source:
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:
Source:
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....
Source:
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:
Source:
Title:
Almonertinib Vs. Erlotinib/Chemotherapy for Neo-adjuVant Treatment of Stage IIIA-N2 EGFR-mutated NSCLC
Excerpt:
......
Trial ID:
Source:
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:
Source:
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:
Source:
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:
Source:
Title:
Real-world protocol for first-line ematinib therapy in patients with locally advanced or metastatic NSCLC who are EGFR mutation-positive (21 L858R)
Excerpt:
...A tumor tissue sample or blood sample was confirmed as an EGFR-sensitive mutation (21 L858R) by an investigator-approved local laboratory test. ...
Trial ID:
Source:
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:
Source:
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....
Source:
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....
Source:
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....
Less C2 evidence
Source:
Title:
Aumolertinib Effectively Reduces Clinical Symptoms of an EGFR L858R-Mutant Non-Small Cell Lung Cancer Case Coupled With Osimertinib-Induced Cardiotoxicity: Case Report and Review
Published date:
05/23/2022
Excerpt:
A 62-year-old non-smoking woman was initially diagnosed with stage cT2aN2M1c IVB NSCLC with synchronous brain and bone metastasis in April 2020. Further genetic screening of the patient identified Leu858Arg (L858R) mutation in EGFR...aumolertinib (110 mg/day), along with a supplement treatment plan was prescribed to the patient. Interestingly, this new treatment plan of aumolertinib significantly inhibited tumor growth in 8 months.
DOI:
10.3389/fendo.2022.833929
