Ameile (aumolertinib)

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

We compare established and emerging perioperative approaches, including aumolertinib, furmonertinib, befotertinib, and neoadjuvant or perioperative osimertinib-based strategies, while underscoring that encouraging early signals should not be equated with established survival benefit before mature event-free survival or overall survival data are available. We also address three unresolved questions: the role of adjuvant chemotherapy in the osimertinib era, the extent to which targeted therapy should move into the neoadjuvant setting, and whether minimal residual disease assessment may eventually support treatment personalization. Overall, current evidence supports adjuvant osimertinib as the reference standard for resected EGFR-mutant NSCLC, whereas other third-generation adjuvant TKIs and perioperative targeted strategies remain promising but should be interpreted according to the maturity of their supporting data and the presence or absence of overall survival benefit.

The LAURA trial (consolidation osimertinib) and POLESTAR trial (consolidation aumolertinib) suggest that targeted consolidation therapy following chemoradiotherapy is a promising approach for Stage III unresectable EGFR-mutant NSCLC. The integration of radiation with targeted therapies, while promising, is complex and requires ongoing research and multidisciplinary efforts to optimize patient outcomes. This review examines the role of radiotherapy in treating EGFR-mutant NSCLC across various stages, highlighting the significance of minimal residual disease and circulating tumor DNA, and identifies key challenges for advancing the field.

P3, N=172, West China Hospital of Sichuan University; West China Hospital of Sichuan University

P2, N=62, West China Hospital of Sichuan University; West China Hospital of Sichuan University

Immediate discontinuation of almonertinib combined with intravenous methylprednisolone resulted in significant clinical and radiological improvement within 7 days. This case highlights two important clinical implications: (1) almonertinib-associated ILD can rapidly progress to a life-threatening condition and (2) occupational inhalational exposures (e.g., dust and smoking) have been directly and indirectly implicated as potential risk factors for EGFR-TKI-induced pulmonary toxicity in prior studies and may have contributed to the outcome in this case. Clinicians should maintain heightened vigilance for respiratory complications during almonertinib therapy, particularly in patients with preexisting pulmonary risk factors.

Initial thoracic radiotherapy (50 Gy in 25 fractions) successfully alleviated the SVCS, enabling subsequent systemic therapy with tislelizumab, nab-paclitaxel, and carboplatin...Treatment with a third-generation EGFR-TKI (aumolertinib) was initiated, resulting in significant symptomatic improvement and a progression-free survival of four months...To our knowledge, this is the first report demonstrating the successful sequential integration of radiotherapy and EGFR-TKI therapy in SMARCA4-dNSCLC. Our experience demonstrates that a proactive, individualized multimodal strategy-integrating radiotherapy for local control and targeted therapy guided by dynamic molecular profiling-can significantly extend survival beyond the historical median of approximately 12 months for SMARCA4-deficient NSCLC.