Firmonertinib combined with cisplatin/carboplatin plus pemetrexed as neoadjuvant therapy in resectable stage II-IIIb EGFR -mutated non–small cell lung cancer: A single-arm, single-center, open-label phase II study.

8058 Background: For patients with resectable, locally advanced EGFR-mutated NSCLC, traditional neoadjuvant chemotherapy yields suboptimal efficacy. While EGFR-TKIs are standard in the adjuvant therapy, their role in neoadjuvant therapy is under active investigation. Methods: This single-arm, phase II study evaluated neoadjuvant firmonertinib plus platinum-based chemotherapy in patients with stage II-IIIB EGFR-mutated NSCLC. The primary endpoint was major pathological response (MPR), the major second endpoint were pathological complete response (pCR), objective response rate (ORR), R0 resection rate and rate of downstaging. Results: Among the 13 patients currently enrolled, 11 completed 4 cycles of neoadjuvant therapy, and 9 underwent radical surgery. The MPR rate and the pCR rate are both currently at 0. The ORR is 77.8%, and the radical resection rate reaches 100%. The TNM tumor stage reduction rate is 66.7%. The incidence of grade 3/4 adverse events is 11.1%, and there are no 5-grade adverse events. Conclusions: Firmonertinib with chemotherapy as neoadjuvant in II-IIIB EGFR-mutated NSCLC demonstrated a promising surgical conversion rate and a manageable safety profile, supporting its feasibility for further study. Clinical trial information: NCT06890182 .