Ameile (aumolertinib)

P2, N=50, Not yet recruiting, Taipei Medical University Hospital

He had been taking almonertinib for 26 months, hybutimibe for 3 months and alirocumab for 1 month prior to admission. Almonertinib is a moderately sensitive substrate of CYP3A4, thereby may elevate statin concentration and increase the likelihood of developing myopathy. For patients who need to take almonertinib and cholesterol-lowering drugs simultaneously, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors and cholesterol absorption inhibitors (such as ezetimibe and hybutimibe) can be considered instead of atorvastatin for the reduction of cardiovascular events.

Animal experiment demonstrated significant DDIs between two drugs no matter single dose or multiple doses were administered, which obviously increased the drug exposure and inhibited elimination. Close attention should be paid to the combination regimens of these two drugs in clinical practice.

Remarkably, the patient has maintained disease-free survival without ILD relapse for 36 months. This case provides clinical evidence that switching to almonertinib may represent a viable and safe therapeutic strategy, thereby addressing a critical unmet need in the management of resected early-stage EGFR-mutant NSCLC after Osi-ILD.

P3, N=192, Active, not recruiting, Guangdong Association of Clinical Trials | Trial completion date: Dec 2027 --> Dec 2028

At 36-month follow-up, she remains disease-free with no significant treatment-related adverse events observed. This case demonstrates a potentially viable approach that warrants further investigation in this high-risk clinical scenario, offering a management template that simultaneously addresses infection resolution and tumor control to enable curative surgery.

P1/2, N=156, Recruiting, Shanghai Hengrui Pharmaceutical Co., Ltd. | Trial completion date: Jun 2027 --> Dec 2029 | Trial primary completion date: Jun 2026 --> Jun 2029

P3, N=192, Active, not recruiting, Guangdong Association of Clinical Trials | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2024 --> Dec 2026 | Recruiting --> Active, not recruiting

P1/2, N=156, Recruiting, Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting

This comparative study demonstrated the improved and consistent activity of aumolertinib across diverse uncommon EGFR E19del subtypes compared to osimertinib, due to its enhanced binding affinity and structural adaptability. These findings support molecular subtype-guided TKI selection, aumolertinib as a first-line option for patients harboring uncommon EGFR E19del variants, particularly in settings lacking comprehensive molecular stratification.

P2, N=32, Active, not recruiting, Guangdong Provincial People's Hospital | Trial completion date: Sep 2027 --> Apr 2026 | Recruiting --> Active, not recruiting

P=N/A, N=4000, Completed, Fudan University | Trial completion date: Sep 2024 --> Feb 2026