A Phase 2 interventional study of Furmonertinib in Non-Small Cell Lung Cancer, sponsored by Shanghai Zhongshan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Shanghai Zhongshan Hospital · Phase 2, Interventional, and Treatment
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.
Not Provided
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 40 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients enrolled into this study will receive furmonertinib 80mg for 8 weeks neoadjuvant therapy before surgery.
Drug: Furmonertinib
Furmonertinib 80mg QD oral 8 weeks.
Also known as: Furmonertinib(AST2818)
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.
Time frame: Approximately 8 weeks following the first dose of study drug
Main Pathological Response（MPR）
Proportion of resected specimens with ≤10% residual tumor cells assessed by surgical specimen pathology
Time frame: Approximately 12 weeks following the first dose of study drug
Pathological Complete Response Rate（pCR)
The proportion of patients with pathological response rate in the resected tumor.
Time frame: Approximately 12 weeks following the first dose of study drug
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
Time frame: Approximately 12 weeks following the first dose of study drug
Delayed Surgery Rate
Proportion of surgeries performed 2 weeks after the last dose of furmonertinib because of adverse drug reactions and other reasons.
Time frame: Approximately 12 weeks following the first dose of study drug
Rate of R0 Resection
The proportion of patients with R0 resection.
Time frame: Approximately 12 weeks following the first dose of study drug
Percentage of minimally invasive mid-rotation open chest
Proportion of minimally invasive surgeries converted to open thoracic for various reasons
Time frame: Approximately 12 weeks following the first dose of study drug
Incidence of adverse drug events (AE)
Unfavorable clinical events in the course of drug treatment
Time frame: Approximately 12 weeks following the first dose of study drug
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Carcinoma, Non-Small-Cell Lung→
Shanghai Zhongshan Hospital