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
1）Dual or multiple primary NSCLC
2）Any prior anti-tumor treatment
3）With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
4）History of interstitial lung disease or with relative risk factors
Single group
Furmonertinib
DrugFurmonertinib 80mg QD oral 8 weeks.
objective response rate(ORR)
According to RECIST 1.1 criteria, after 8 weeks of neoadjuvant therapy with furmonertinib CT scans scans assessed the proportion of patients in partial and complete remission.
Main Pathological Response（MPR）
Proportion of resected specimens with ≤10% residual tumor cells assessed by surgical specimen pathology
Pathological Complete Response Rate（pCR)
The proportion of patients with pathological response rate in the resected tumor.
Pathological Nodal Downstaging Rate
Neoadjuvant confirmed by pathologic evaluation of tumors and other tissues removed during surgery Percentage of patients downregulated from lymph node-positive to negative after treatment
Delayed Surgery Rate
Proportion of surgeries performed 2 weeks after the last dose of furmonertinib because of adverse drug reactions and other reasons.
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Shanghai Zhongshan Hospital
Lead sponsor
Xuhui Central Hospital, Shanghai
Collaborator
Shanghai Minhang Central Hospital
Collaborator
Ningbo No. 1 Hospital
Collaborator
