Ivesa (firmonertinib)

However, both 3-year RFS and 5-year OS were significantly better in group A (P=0.045; P=0.046) and group B (P=0.004; P=0.006) compared with group C. For peripheral solid stage IA3 LUAD with pulmonary dysfunction, SR combined with EGFR-TKI did not increase the incidence rate of grade 1-2 AEs, and the 3y-RFS and 5y-OS were superior to those SR alone. Better study designs are required to compare long term survival between SR + EGFR-TKI and lobectomy.

P2, N=45, Not yet recruiting, Shanghai Pulmonary Hospital, Shanghai, China

P2, N=46, Completed, Sun Yat-sen University | Recruiting --> Completed | N=30 --> 46

P=N/A, N=42, Recruiting, Guangzhou University of Traditional Chinese Medicine | Not yet recruiting --> Recruiting

We report a 73-year-old woman with EGFR L858R-mutated NSCLC who developed LM after multiple lines of therapy, including gefitinib, osimertinib, chemotherapy, anti-angiogenic therapy, and radiotherapy. Treatment with high-dose furmonertinib (240 mg daily) combined with bevacizumab resulted in symptom relief and additional survival. Remarkably, her overall survival exceeded six years from initial diagnosis. This case highlights the potential role of dose-escalated furmonertinib as salvage therapy in LM after osimertinib resistance and underscores the importance of sequential and multimodal management in advanced EGFR-mutant NSCLC.

P1, N=288, Recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Not yet recruiting --> Recruiting

P2, N=63, Not yet recruiting, Jiangmen Central Hospital

This case suggests that, in EGFR-mutant advanced NSCLC with extensive CNS progression after multiline treatment failure in whom radiotherapy is not feasible, high-dose furmonertinib may represent a potential salvage option and may help inform individualized treatment strategies in this high-risk population. This single case is hypothesis-generating and larger cohorts/prospective studies are needed to confirm efficacy, safety, and appropriate patient selection.

The management of human epidermal growth factor receptor 2 (HER2)-mutant non-small cell lung cancer (NSCLC) remains a significant clinical challenge, with limited effective and accessible treatment options beyond antibody-drug conjugates such as trastuzumab deruxtecan (T-DXd)...Following chemotherapy and sintilimab failure in August 2025 due to progressive disease, furmonertinib rechallenge at 160 mg/day again induced a response within 5 days, with no grade ≥3 adverse events...The structural homology between HER2 p.Y772_A775dup and EGFR exon 20 "near-loop" insertions may facilitate TKI binding. Furmonertinib emerges as a potential, cost-effective oral therapeutic alternative for this patient population, especially when standard therapies are not feasible, warranting further prospective investigation.

P1, N=160, Active, not recruiting, ArriVent BioPharma, Inc. | Trial completion date: Dec 2025 --> Dec 2026

P1, N=94, Not yet recruiting, Fuzhou General Hospital

High-dose Furmonertinib combined with IP is an effective and well-tolerated regimen for EGFR-mutant NSCLC-LM. The addition of Bevacizumab may further improve outcomes, offering a promising strategy for refractory patients.