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DRUG:

Ameile (aumolertinib)

i
Other names: EQ 143, HS10296, HS-10296, HS 10296, EQ143, EQ-143
Company:
Abdul Latif Jameel Health, Jiangsu Hansoh Pharma
Drug class:
EGFR inhibitor
Related drugs:
3d
Risk of treatment-related toxicity from EGFR tyrosine kinase inhibitors: a systematic review and network meta-analysis of randomized clinical trials in EGFR-mutant non-small cell lung cancer. (PubMed, J Thorac Dis)
This review included 23 randomized clinical trials incorporating 7,006 patients and 11 treatments: erlotinib, gefitinib, icotinib, afatinib, dacomitinib, osimertinib, furmonertinib, aumolertinib, pemetrexed-free chemotherapy (PfCT), pemetrexed-based chemotherapy (PbCT) and placebo. Difference in safety between the third-generation EGFR-TKIs was also first investigated comprehensively. Furthermore, this review elaborated the varied predominate spectrum and ranked the toxicity of EGFR-TKIs for providing toxicity rationale for treatment decisions.
Clinical • Retrospective data • Review • Journal
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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Tagrisso (osimertinib) • erlotinib • Gilotrif (afatinib) • gefitinib • pemetrexed • Conmana (icotinib) • Ameile (aumolertinib) • Vizimpro (dacomitinib) • Ivesa (firmonertinib)
3d
Determination of furmonertinib in human plasma and cerebrospinal fluid by UPLC-MS/MS: Application in lung cancer patients with and without brain metastasis. (PubMed, J Chromatogr B Analyt Technol Biomed Life Sci)
Quantitative ion pairs were m/z 569.3 → 72.2 for furmonertinib and m/z 526.5 → 72.2 for aumolertinib, which was used as the internal standard (IS). The established analytical methods showed great sensitivity, simplicity, accuracy and reliability for the analysis of furmonertinib in human plasma and CSF. This assay would be helpful to predict the effectiveness and toxicities of furmonertinib in the pursuit of precision medicine for lung cancer patients.
Journal
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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Ameile (aumolertinib) • Ivesa (firmonertinib)
5d
Aumolertinib combined with anlotinib inhibits proliferation of non-small cell lung cancer cells by down-regulating the PI3K/AKT pathway (PubMed, Nan Fang Yi Ke Da Xue Xue Bao)
Aumolertinib combined with anlotinib can effectively inhibit NSCLC cell proliferation by downregulating the PI3K-Akt pathway, suggesting a potentially new option for NSCLC treatment.
Journal • IO biomarker
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BCL2 (B-cell CLL/lymphoma 2) • CDH1 (Cadherin 1) • MMP2 (Matrix metallopeptidase 2) • BAX (BCL2-associated X protein) • VIM (Vimentin) • MMP9 (Matrix metallopeptidase 9)
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BCL2 expression • CDH1 expression • BAX expression • VIM expression
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Focus V (anlotinib) • Ameile (aumolertinib)
9d
Enrollment open
|
Tagrisso (osimertinib) • Ameile (aumolertinib) • Ivesa (firmonertinib)
15d
Almonertinib Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB Non-Small Cell Lung Cancer With EGFR-sensitive Mutations (clinicaltrials.gov)
P3, N=192, Active, not recruiting, Jiangsu Hansoh Pharmaceutical Co., Ltd. | Trial primary completion date: Jan 2026 --> Jul 2024
Trial primary completion date
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EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
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Ameile (aumolertinib)
22d
Third-generation EGFR-TKI Treatment in Metastatic EGFR-mutant NSCLC (clinicaltrials.gov)
P=N/A, N=4000, Completed, Fudan University | N=500 --> 4000
Enrollment change • Metastases
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Tagrisso (osimertinib) • Ameile (aumolertinib) • Ivesa (firmonertinib)
2ms
Successful rapid improvement of acute respiratory distress syndrome induced by EGFR-mutated non-small cell lung cancer with almonertinib: a case report. (PubMed, BMC Pulm Med)
This case represents the first documented successful treatment of ARDS induced by EGFR E19 mutated NSCLC using almonertinib. The favorable clinical response observed in this critically ill patient suggests that almonertinib may be a viable therapeutic option for managing severe complications in NSCLC. Further research is necessary to corroborate these findings and optimize dosage and toxicity management strategies for broader clinical application.
Journal
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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Ameile (aumolertinib)
2ms
Efficacy and patient-reported outcomes in advanced non-small cell lung cancer patients receiving aumolertinib as first-line therapy: a real-world study. (PubMed, Front Pharmacol)
Aumolertinib demonstrated superior progression-free survival (PFS) and a well-tolerated toxicity profile compared to gefitinib in front-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in the AENEAS trial. In this real-world study, aumolertinib showed comparable disease control and objective response rates as reported in the AENEAS trial for advanced NSCLC patients with EGFR-sensitizing mutations. Aumolertinib treatment improved PROs, further supporting it in first-line clinical practice.
Journal • Real-world evidence • Patient reported outcomes • Real-world • Metastases
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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gefitinib • Ameile (aumolertinib)
2ms
New trial • Metastases
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Tagrisso (osimertinib) • Ameile (aumolertinib) • Ivesa (firmonertinib)
2ms
cost-effectiveness of aumolertinib as first-line treatment for EGFR-mutated advanced nonsmall-cell lung cancer. (PubMed, Future Oncol)
Sensitivity and scenario analyses were performed to explore the robustness of the model. Compared with gefitinib, aumolertinib yielded an additional 0.941 expected life-years and 0.692 quality-adjusted life-years (QALYs), with an incremental cost of $18,855.55 over a 20-year time horizon. The incremental cost-effectiveness ratios were $20,051.67/life-year and $27,272.29/QALY, that below the willing-to-pay threshold of $38,223.34/QALY. Aumolertinib was a cost-effective alternative first-line treatment for patients with epidermal growth factor receptor-positive advanced nonsmall-cell lung cancer in China.
Journal • HEOR • Cost-effectiveness • Cost effectiveness • Metastases
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EGFR (Epidermal growth factor receptor)
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EGFR mutation • EGFR positive
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gefitinib • Ameile (aumolertinib)
2ms
New trial
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Tagrisso (osimertinib) • Ameile (aumolertinib) • Ivesa (firmonertinib)
2ms
A Phase I Study of HRS2300 or Combined With SHR-1316 or SHR-1701 or Trametinib or Almonertinib in Patients With Advanced Malignancies (clinicaltrials.gov)
P1, N=13, Terminated, Jiangsu HengRui Medicine Co., Ltd. | N=345 --> 13 | Recruiting --> Terminated; Sponsor R&D strategy adjustment
Enrollment change • Trial termination • Metastases
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Mekinist (trametinib) • Ameile (aumolertinib) • retlirafusp alfa (SHR-1701) • Ariely (adebrelimab)
3ms
New P1 trial • Combination therapy • Metastases
|
Ameile (aumolertinib)
3ms
Aumolertinib in EGFR-Mutant Resected Stage IB-IIIA NSCLC (AERESA). (clinicaltrials.gov)
P2, N=85, Recruiting, Sun Yat-sen University | Not yet recruiting --> Recruiting
Enrollment open
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Ameile (aumolertinib)
3ms
Simultaneous determination of icotinib, osimertinib, aumolertinib, and anlotinib in human plasma for therapeutic drug monitoring by UPLC-MS/MS. (PubMed, J Pharm Biomed Anal)
Overall, the method proved to be sensitive, reliable, and straightforward, enabling successful simultaneous determination of blood concentrations of icotinib, osimertinib, aumolertinib, and anlotinib in patients. The validity of the method has been confirmed across various instruments.
Journal
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FGFR (Fibroblast Growth Factor Receptor)
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Tagrisso (osimertinib) • Focus V (anlotinib) • Conmana (icotinib) • Ameile (aumolertinib)
3ms
Long term survival achieved through combination of almonertinib and pyrotinib in EGFR-mutant/HER2-amplified advanced NSCLC patient: a case report and literature review. (PubMed, Front Oncol)
The patient achieved partial remission and did not show any further progression during the follow-up period. For NSCLC patients with both EGFR mutation and HER2 amplification, the combination of almonertinib and pyrotinib is a valuable therapy that can continuously reduce tumor burden and achieve long-term survival.
Review • Journal • Metastases
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
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Irene (pyrotinib) • Ameile (aumolertinib)
3ms
Synergistic antitumor activity of baicalein combined with almonertinib in almonertinib-resistant non-small cell lung cancer cells through the reactive oxygen species-mediated PI3K/Akt pathway. (PubMed, Front Pharmacol)
Furthermore, baicalein combined with almonertinib results in massive accumulation of reactive oxygen species (ROS) and preincubation with N-acetyl-L-cysteine (ROS remover) prevents proliferation as well as inhibits apoptosis induction, with partial recovery of the decline of p-PI3K and p-Akt. The combination of baicalein and almonertinib can improve the antitumor activity in almonertinib-resistant NSCLC through the ROS-mediated PI3K/Akt pathway.
Journal • PARP Biomarker
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CASP3 (Caspase 3) • CASP9 (Caspase 9)
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Ameile (aumolertinib)
4ms
Potential Utility of a 4th-Generation EGFR-TKI and Exploration of Resistance Mechanisms-An In Vitro Study. (PubMed, Biomedicines)
Ba/F3 cells with an osimertinib-resistant secondary mutation were refractory to all 3G TKIs tested (alflutinib, lazertinib, rezivertinib, almonertinib, and befotertinib)...HCC827BIR cells had MET gene amplification and were sensitive to a combination of capmatinib (MET-TKI) and BI4020...This study suggests that erlotinib may be more suitable than 4G TKIs to overcome secondary mutations after front-line osimertinib. We found that off-target mechanisms that cause resistance to earlier-generation TKIs will also cause resistance to 4G TKIs.
Preclinical • Journal
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MET (MET proto-oncogene, receptor tyrosine kinase)
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Tagrisso (osimertinib) • erlotinib • Ameile (aumolertinib) • Tabrecta (capmatinib) • Ivesa (firmonertinib) • Lazcluze (lazertinib) • BI-4020 • Semena (befotertinib) • Rui Bi Da (rezivertinib)
4ms
Central nervous system efficacy of aumolertinib versus gefitinib in patients with untreated, EGFR-mutated, advanced non-small cell lung cancer: data from a randomized phase III trial (AENEAS). (PubMed, Cancer Commun (Lond))
These results indicate a potential advantage of aumolertinib over gefitinib in terms of CNS PFS and the risk of CNS progression in patients with EGFR-mutated advanced NSCLC with baseline CNS metastases.
Clinical • P3 data • Journal • Metastases
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EGFR (Epidermal growth factor receptor)
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gefitinib • Ameile (aumolertinib)
4ms
New P2 trial
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EGFR (Epidermal growth factor receptor)
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Ameile (aumolertinib) • etoposide oral
5ms
Neoadjuvant aumolertinib monotherapy for EGFR-mutant lung squamous cell carcinoma: a case report. (PubMed, Transl Lung Cancer Res)
The result of patient treatment demonstrated the potential feasibility of neoadjuvant Aumolertinib monotherapy for locally advanced LUSQm. The report provides some support for neoadjuvant target-therapy for LUSQm.
Journal
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EGFR (Epidermal growth factor receptor)
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Ameile (aumolertinib)
5ms
New trial • Metastases
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Ameile (aumolertinib)
5ms
New P1/2 trial • Combination therapy • Metastases
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carboplatin • pemetrexed • Ameile (aumolertinib) • SHR-A1921 • SHR-A2009
5ms
Phase II Trial of Almonertinib Plus Lastet for EGFR+ Non-small Cell Lung Cancer (clinicaltrials.gov)
P2, N=60, Not yet recruiting, Shanghai Pulmonary Hospital, Shanghai, China
New P2 trial • Combination therapy • Metastases
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Ameile (aumolertinib) • etoposide oral
5ms
Identification of EGFR R776H germline mutations in a patient with multifocal lung adenocarcinoma: A case report and literature review. (PubMed, Respir Med Case Rep)
Following the lobectomy, the patient received treatment with almonertinib, a third-generation EGFR tyrosine kinase inhibitor (TKI), and at the latest follow-up, the patient has achieved partial remission...It stresses the importance of acquiring a comprehensive family history and performing genetic testing on leukocytes. Moreover, for the infrequent EGFR R776H mutation, third generation EGFR-TKIs may be a viable option.
Review • Journal
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EGFR (Epidermal growth factor receptor)
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Ameile (aumolertinib)
5ms
Gumarontinib Combined With 3rd EGFR-TKI in Patients With Non-small Cell Lung Cancer. (clinicaltrials.gov)
P2, N=91, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
New P2 trial • Metastases
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Tagrisso (osimertinib) • Ameile (aumolertinib) • Ivesa (firmonertinib) • Haiyitan (gumarontinib)
6ms
PIKACHU: Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation (clinicaltrials.gov)
P2, N=6000, Recruiting, Hunan Province Tumor Hospital | Phase classification: P --> P2 | N=100 --> 6000 | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2024 --> Dec 2026
Phase classification • Enrollment change • Trial completion date • Trial primary completion date
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EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
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)
6ms
Almonertinib and alflutinib show novel inhibition on rare EGFR S768I mutant cells. (PubMed, Clin Transl Oncol)
These findings suggest that almonertinib and alflutinib may be potential therapeutic options for non-small cell lung cancer patients with the EGFR S768I mutation.
Journal
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EGFR (Epidermal growth factor receptor)
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Tagrisso (osimertinib) • Gilotrif (afatinib) • gefitinib • Ameile (aumolertinib) • Ivesa (firmonertinib)
6ms
New P2/3 trial • Metastases
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Ameile (aumolertinib) • PM1080
7ms
Phase classification • Metastases
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EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR L861Q • EGFR G719X • EGFR exon 20 mutation
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cisplatin • Tagrisso (osimertinib) • carboplatin • gemcitabine • albumin-bound paclitaxel • pemetrexed • Ameile (aumolertinib)
7ms
Clinical efficacy and safety analysis of aumolertinib in real-world treatment of EGFR-mutated advanced non-small-cell lung cancer. (PubMed, Front Pharmacol)
Furthermore, subsequent-line treatment multivariate Cox regression analysis showed a statistically significant impact of elevated creatine kinase on median PFS (p = 0.026) and a significant effect on the number of metastatic organs (p = 0.017), co-mutation (p = 0.035), and elevated creatine kinase (p = 0.014) on median OS. Aumolertinib has shown clinical significance and can safely be used in the real-world setting for patients with EGFR mutation-positive NSCLC.
Journal • HEOR • Real-world evidence • Real-world • Metastases
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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Ameile (aumolertinib)
7ms
ACHIEVE: Almonertinib as First-line Treatment in Patients With EGFR Mutations Positive in Advanced NSCLC With Brain Metastases (clinicaltrials.gov)
P2, N=63, Active, not recruiting, Zhejiang Cancer Hospital | Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2024 --> Jun 2024
Enrollment closed • Trial primary completion date • Metastases
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EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
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Ameile (aumolertinib)
8ms
LungMate-007: Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Non-small Cell Lung Cancer (clinicaltrials.gov)
P2, N=56, Active, not recruiting, Shanghai Pulmonary Hospital, Shanghai, China | Recruiting --> Active, not recruiting
Enrollment closed
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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Ameile (aumolertinib)
10ms
Neoadjuvant Aumolertinib in Patients With AI-diagnosed EGFR-mutant High-risk Pulmonary Ground-glass Opacity. (clinicaltrials.gov)
P2, N=22, Recruiting, The First Affiliated Hospital of Guangzhou Medical University | Not yet recruiting --> Recruiting
Enrollment open
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EGFR (Epidermal growth factor receptor)
|
EGFR mutation
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Ameile (aumolertinib)
10ms
Lipocalin 2 (LCN2) confers acquired resistance to almonertinib in NSCLC through LCN2-MMP-9 signaling pathway. (PubMed, Pharmacol Res)
Pharmacological inhibition of MMP-9 could overcome resistance to almonertinib, as evidenced in both in vitro and in vivo models. Our findings suggest that LCN2 was a crucial regulator for conferring almonertinib-resistance in NSCLC and demonstrate the potential utility of targeting the LCN2-MMP-9 axis for clinical treatment of almonertinib-resistant lung adenocarcinoma.
Preclinical • Journal
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EGFR (Epidermal growth factor receptor) • HIF1A (Hypoxia inducible factor 1, alpha subunit) • TGFB1 (Transforming Growth Factor Beta 1) • LCN2 (Lipocalin-2) • MMP9 (Matrix metallopeptidase 9)
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EGFR mutation • EGFR T790M • EGFR H1975
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Ameile (aumolertinib)
10ms
New P2 trial
|
Ameile (aumolertinib)
11ms
RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations (clinicaltrials.gov)
P2, N=108, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
New P2 trial • Metastases
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HER-2 (Human epidermal growth factor receptor 2)
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Tagrisso (osimertinib) • Irene (pyrotinib) • Ameile (aumolertinib) • Aidixi (disitamab vedotin) • Ivesa (firmonertinib)
12ms
Clinical analysis of lung adenocarcinoma with epidermal growth factor receptor mutation transformed into sarcoma (PubMed, Zhonghua Jie He He Hu Xi Za Zhi)
We reported a patient with lung adenocarcinoma who developed EGFR-T790M mutation after first-line treatment with icotinib and sarcoma transformation after second-line treatment with almonertinib. Sarcoma transformation can be one of the forms of drug resistance in patients with lung adenocarcinoma with EGFR-TKIs. The prognosis of patients with adenocarcinoma after transformation into sarcoma is poor.
Journal • IO biomarker
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EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR mutation • EGFR T790M • ALK mutation • ROS1 mutation
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Conmana (icotinib) • Ameile (aumolertinib)
12ms
Efficacy and Safety of Ametinib Combined With Bevacizumab in First-line Treatment of Non-oligometastatic Advanced NSCLC With EGFR-mutations. (ChiCTR2300075120)
P2, N=100, Recruiting, The Second Affiliated Hospital of Shandong First Medical University; The Second Affiliated Hospital of Shandong First Medical University
New P2 trial
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR positive
|
Avastin (bevacizumab) • Ameile (aumolertinib)
1year
APPROACH: MRD Guiding Treatment After Almonertinib Induction Therapy for EGFRm+ Stage III NSCLC in the MDT Diagnostic Model. (clinicaltrials.gov)
P3, N=192, Recruiting, Guangdong Association of Clinical Trials | Not yet recruiting --> Recruiting | Phase classification: P2 --> P3 | Trial completion date: Aug 2024 --> Dec 2026 | Trial primary completion date: Oct 2022 --> Dec 2024
Enrollment open • Phase classification • Trial completion date • Trial primary completion date
|
Ameile (aumolertinib)
1year
Clinical • PARP Biomarker
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ARID1A (AT-rich interaction domain 1A)
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ARID1A mutation • EGFR V834L
|
Lynparza (olaparib) • Ameile (aumolertinib)
1year
ARISE: Almonertinib as First-line Treatment in Patients With EGFR+ Positive Pulmonary Adenosquamous Carcinoma or Combined Adenocarcinoma and Squamous Cell Carcinoma (clinicaltrials.gov)
P2, N=13, Recruiting, Fujian Cancer Hospital | Not yet recruiting --> Recruiting | N=134 --> 13 | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: May 2023 --> Dec 2023
Enrollment open • Enrollment change • Trial completion date • Trial primary completion date
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EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
Ameile (aumolertinib)