Furmonertinib Mesylate Neoadjuvant Treatment of Resectable Stage Ⅱ-ⅢB Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor（EGFR）Sensitive Mutation：a Prospective，Muliticenter，Open Label，Phase Ⅱ Single-arm Study
EGFR-TKI has firmly established itself as a first-line treatment for advanced lung cancer with EGFR-sensitive mutations, and the ADAURA study has added to its indications for use as postoperative adjuvant therapy in early- and mid-stage lung cancer.However, clinical data on neoadjuvant EGFR-TKI therapy are still incomplete. A phase II clinical study, CTONG1103, currently ongoing, comparing the efficacy of the first generational EGFR-TKI erlotinib and gemcitabine combined with cisplatin as neoadjuvant therapy for stage IIIA-N2 EGFR mutation-positive non-small-cell lung cancer, did not yield significantly positive objective remission rate (ORR) results. Furmonertinib is a third-generation Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations.Furmonertinib demonstrates definite efficacy and favorable safety in first-line EGFR-sensitive mutations and EGFR T790M Mutations in second-line and late-line treatment of advanced NSCLC.The aim of this study was to explore the efficacy and safety of furmonertinib neoadjuvant therapy for resectable stage II-IIIB EGFR-sensitive mutant non-small cell lung cancer efficacy and safety. Patinents are planned to be recruited from five centers in China. Eligible patients will receive furmonertinib neoadjuvant therapy for 8 weeks to evaluate the efficacy and safety of furmonnertinib neoadjuvant.
• 1）Provide informed consent prior to any study specific procedures
• 2）at least 18 years of age，not more than 75 years
• 3）Histology or cytology diagnose of non-small cell lung cancer within 60 days
• 4）ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks
• 5）Stage II-IIIB NSCLC that is expected to be resectable, as assessed by the investigator (8 thUICCTNM staging), with stage IIIB only including cT3N2M0 patients
• 6）According to RECIST 1.1, patients have at least one measureable tumor lesion (The longest axis ≥10mm)
• 7）EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
• 8）Without prior anti-tumor treatment
• 9\) Withe adequate organ function of hematology, liver and kidney
• 10）Using adequate and effective contraception, Male patients should be use condoms; women should refrain from breastfeeding and have a negative pregnancy test prior to the first administration of the study drug if within during child-bearing age