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Association details:
| Biomarker: | EGFR mutation |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Ameile (aumolertinib) (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
367P - High-dose aumolertinib in EGFR-mutant NSCLC patients with brain metastases: Primary data from ACHIEVE
Published date:
11/28/2022
Excerpt:
Treatment-naïve EGFR-mutant NSCLC patients with asymptomatic brain metastases received aumolertinib 165mg orally once daily….The overall ORR was 90.9% (20/22; 95% CI: 70.8-98.9). The CNS ORR was 86.3 (19/22; 95% CI: 65.1-97.1). The overall and CNS DCR were both 100%.
Trial ID:
Source:
Title:
Aumolertinib activity in patients with CNS metastases and EGFR-mutated NSCLC treated in the randomized double-blind phase III trial (AENEAS).
Published date:
05/26/2022
Excerpt:
Au also achieved longer CNS median PFS over G in cFAS (29.0 vs 8.3 months; HR = 0.323; 95% CI, 0.181-0.576; P< 0.0001)….Au demonstrated superior clinical efficacy against CNS metastases over G as first-line therapy in EGFR-mutated advanced NSCLC, and the safety profile was consistent with that reported previously.
DOI:
10.1200/JCO.2022.40.16_suppl.9096
Trial ID:
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:
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....
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 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:
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:
Clinical study of ametinib as neoadjuvant therapy in EGFR positive patients with stage IIB to IIIA non-small cell lung cancer
Excerpt:
...Patients with EGFR mutation positive stage IIB to IIIA NSCLC confirmed by histopathology and / or cytology; 3. ...
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:
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:
Mechanism of resistance to second-line Aumolertinib and exploring combined treatment after resistance
Excerpt:
...Patients with locally advanced (stage IIIB) or metastatic (stage IV) NON-small cell lung cancer with positive EGFR-resistant mutations who are unable to undergo curative surgery or radiotherapy and whose T790M mutation is confirmed; 2. ...
Trial ID:
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:
Source:
Title:
Clinical observation of Aumolertinib in the treatment of residual ground glass nodules in patients with Ⅰ stage EGFR mutation positive after resection of lung cancer
Excerpt:
......
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 Vs. Erlotinib/Chemotherapy for Neo-adjuVant Treatment of Stage IIIA-N2 EGFR-mutated NSCLC
Excerpt:
......
Trial ID:
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:
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:
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:
In vitro antitumor activity and clinical efficacy of almonertinib in NSCLC with uncommon EGFR mutation
Excerpt:
...In vitro experiments (1) Aged 18 to 75 years; (2) NSCLC diagnosed by histopathology and expressing any rare EGFR mutation such as 20 insertion, G719X, L861Q, S768I or L747S; (3) Malignant pleural effusion exists, and pleural effusion treatment is required; (4) The subjects themselves participated voluntarily and signed the informed consent in writing. ...
Trial ID:
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:
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:
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:
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....
Source:
Title:
Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Non-small Cell Lung Cancer
Excerpt:
...- Lung adenocarcinoma patient with EGFR sensitive mutation as confirmed by needle biopsy;...
Trial ID:
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:
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
Excerpt:
...The tumor harbors uncommon EGFR mutations (one of the following...
Trial ID:
Source:
Title:
Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC
Excerpt:
...Patients must has sensitizing EGFR mutation (e.g....
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:
Less C2 evidence
Source:
Title:
480P - Aumolertinib as adjuvant therapy for resectable stage I-III EGFR-mutant NSCLC: Also effective in EGFR co-mutation
Published date:
11/27/2023
Excerpt:
The 1-year DFS rate is 100%....This study demonstrated the significant efficacy of aumolertinib as adjuvant therapy for completely resected stage I-III EGFR-mutated NSCLC, and reported the consistent efficacy of aumolertinib in pts with co-mutation for the first time.
Source:
Title:
Almonertinib plus chemotherapy versus almonertinib alone in second-line treatment of advanced non-small cell lung cancer with mutated epidermal growth factor receptor: a retrospective study
Published date:
09/27/2023
Excerpt:
For advanced NSCLC patients with EGFR mutations, second-line treatment with almonertinib plus chemotherapy significantly improved PFS compared with almonertinib alone without a significant increase in adverse events, providing efficacy and safety.
Secondary therapy:
Chemotherapy
DOI:
10.3389/fonc.2023.1248690
Source:
Title:
Safety and Efficacy of Aumolertinib in Patients with advanced NSCLC Harboring Uncommon EGFR Mutations: Cohort 2 Updated
Published date:
08/08/2023
Excerpt:
In patients with advanced NSCLC harboring uncommon EGFR mutations, high-dose aumolertinib demonstrated a tolerable safety profile and encouraging antitumor activity in NSCLC pts harboring uncommon EGFR mutations.
Source:
Title:
A Study of Aumolertinib Monotherapy or Combination Treated EGFR-mutated NSCLC Patients with Symptomatic Brain Metastases
Published date:
08/08/2023
Excerpt:
The study retrospectively analyzed 33 patients with advanced EGFR-mutated positive NSCLC with symptomatic brain metastases….The confirmed partial response (PR) were 9 (40.9%) patients and stable disease (SD) were 13 (59.1%) patients, all the patients had progressed. The ORR was 40.9% (9/22) and the DCR was 100 % (22/22). The median PFS and OS were 12.1months and 32.0 months, respectively. The main treatment regimens are aumolertinib monotherapy (40.9%), aumolertinib combined with WBRT (36.4%)....This retrospective study first demonstrated aumolertinib monotherapy or combined with local therapy had prolong the survival time and also improve the BM-related neurological symptoms and quality of life, no matter the first-line or therapy.
Source:
Title:
Conversion to Aumolertinib in NSCLC Patients with EGFR Mutations Who Are Safety Intolerant after Osimertinib Treatment: A Retrospective Study
Published date:
08/08/2023
Excerpt:
We retrospectively collected data from NSCLC patients with EGFR-mutation who were intolerant after osimertinib treatment and received aumolertinib 110mg daily...15 patients subsequently received aumolertinib treatment. The 3-month conversion success rate was 100%, and overall ORR was 80% (2 CR, 10 PR, 95% CI: 51.9-95.7), DCR was 100%. ORR in subgroups with safety intolerance (rash and diarrhea) after treatment with osimertinib were respectively 87.5% (2 CR, 5 PR, 95% CI: 47.3-99.7) and 100% (2 CR, 4 PR).... This study confirmed safety and efficacy of aumolertinib in EGFR-mutation advanced NSCLC patients with safety intolerance after treatment with osimertinib...
Source:
Title:
The Safety and Efficacy of Aumolertinib in Advanced EGFR-mutant NSCLC Patients Who Were Intolerant to Osimertinib Treatment
Published date:
08/08/2023
Excerpt:
Aumolertinib is a safety and efficacy choice in locally advanced or metastatic EGFR-mutant NSCLC pts who were intolerant to osimertinib treatment.
Source:
Title:
18P - Stereotactic radiotherapy(SRT) in combination with Aumolertinib to treat intracranial oligometastatic Non-Small Cell Lung Cancer (NSCLC): An update of the phase II, prospective study
Published date:
03/23/2023
Excerpt:
Intracranial oligometastatic patients with EGFR sensitive mutations (EGFR-TKIs naive) were enrolled and received aumolertinib 110 mg daily until intracranial disease progression….After administration of aumolertinib, the best response of all patients in intracranial and extracranial lesions was partial response (PR), with an iORR of 100%.
Trial ID:
Source:
Title:
371P - Real-world data of first-line treatment with aumolertinib for elderly EGFR+ NSCLC patients
Published date:
11/28/2022
Excerpt:
This study enrolled pts with stage IIA-IVB EGFR+ NSCLC who received aumolertinib alone as first-line therapy...Overall, ORR and DCR were 74.2% and 97.0%, respectively...ORR was 71.4% and 77.4% for pts ≥65 and <65 yr, respectively, and DCR was 97.1% and 96.8%, respectively.
Source:
Title:
375P - Stereotactic radiotherapy (SRT) in combination with aumolertinib to treat intracranial oligometastatic non-small cell lung cancer (NSCLC): A phase II, prospective study
Published date:
11/28/2022
Excerpt:
Aumolertinib showed preliminary efficacy and good tolerability in intracranial oligometastatic EGFR mutated NSCLC.
Trial ID:
Source:
Title:
EP08.02-004 - Aumolertinib in Treatment-Naïve EGFR-mutant NSCLC Patients With Brain Metastases: Primary Efficacy and Safety Data from the ARTISTRY
Published date:
07/12/2022
Excerpt:
Aumolertinib showed preliminary antitumor activity with a manageable safety profile as first-line therapy in EGFR-mutant NSCLC patients with brain metastases.
Trial ID:
Source:
Title:
EP08.02-006 Data from Real World to Evaluate the Efficacy of Almonertinib in EGFR-mutant NSCLC Patients
Published date:
07/12/2022
Excerpt:
100 patients’ medical records were reviewed for EGFR mutated ANSCLC treated with almonertinib, Data from 2020/4/1 to 2021/3/1 in Henan Cancer Hospital were also collected and retrospectively analyzed…. The ORR of the patients who received almonertinib as first-line treatment (n=45) was 71%, mPFS was 16.7 months, and mOS was still not reached....Almonertinib has been shown good efficacy and safety in EGFR-mutant ANSCLC.... Elevated creatine kinase is an important predictor of longer mPFS.
Source:
Title:
86P-Aumolertinib as adjuvant therapy in postoperative EGFR-mutated non-small cell lung cancer
Published date:
03/23/2022
Excerpt:
At the data cutoff, all patients have no symptoms of tumor recurrence, 25 (37.9%) patients have been followed up for over 1 year. At 12 months, 100% patients were alive and disease-free...This is the first study to demonstrate that aumolertinib has preliminary efficacy and a tolerable safety profile in patients with completely resected stage I-III NSCLC harboring EGFR mutations.
DOI:
https://doi.org/10.1016/j.annonc.2022.02.09687
Source:
Title:
Intracranial complete remissions in an aumolertinib-treated EGFR mutation-positive non-small cell lung cancer (NSCLC) patient with symptomatic brain metastases and Eastern Cooperative Oncology Group performance status (ECOG PS) up to 4: a case report
Published date:
02/28/2023
Excerpt:
Further tissue and imaging analysis revealed EGFR-mutant stage IV (cT2N3M1) NSCLC...After 2 weeks of aumolertinib administration, the patient showed significant improvement...
DOI:
10.21037/tcr-22-1614
Source:
Title:
Sequence-dependent synergistic effect of aumolertinib-pemetrexed combined therapy on EGFR-mutant non-small-cell lung carcinoma with pre-clinical and clinical evidence
Published date:
05/03/2022
Excerpt:
Their inhibition effects on cell proliferation and metastasis were firstly compared upon three human NSCLC cell lines in vitro...Aumolertinib-pemetrexed combined therapy is promising for EGFR mutant NSCLC but only in right administration sequence.
Secondary therapy:
pemetrexed
DOI:
https://doi.org/10.1186/s13046-022-02369-3
