This is a Phase II, single-arm, open-label, multicenter clinical study aimed at evaluating the efficacy and safety of Firmonertinib 160 mg combined with Bevacizumab as neoadjuvant therapy in patients with resectable stage II-IIIB Epidermal Growth Factor Receptor(EGFR)-mutated non-small cell lung cancer.
Male or female, aged ≥18 years.
Histologically/cytologically confirmed primary non-small cell lung cancer within 60 days prior to the study.
Stage II-IIIB disease evaluated by endobronchial ultrasound guided tranbronchial needle aspiration(EBUS-TBNA), mediastinoscopy, or Positron Emission Tomography/Computed Tomography (PET/CT), with lesions planned for radical resection after neoadjuvant therapy.
EGFR mutation-positive confirmed by local laboratory testing of tissue or blood samples.
Presence of small cell lung cancer or mixed pathological types of NSCLC. EGFR exon 20 insertion mutation detected by genetic testing.
Exposure to any other antitumor therapy prior to enrollment, including perioperative radiotherapy.
The patient is in pregnancy or lactation.
History of other malignant tumors, or currently combined with other malignant tumors (except for malignancies that have undergone radical surgery with no recurrence within 5 years post-operation, such as cervical carcinoma in situ, basal cell carcinoma of the skin, and papillary thyroid carcinoma, etc.).
Single group
Firmonertinib Mesilate Tablets
DrugFirmonertinib Mesilate Oral administration 160 mg once daily for 3 months before surgery. Radical tumor resection will be performed at least 6 weeks after completion of Bevacizumab treatment. After surgery, the treatment plan was determined by the researchers, with options including Firmonertinib Mesilate Tablets: Oral administration once daily, 80mg per dose, for 3 years or until disease progression or intolerable toxicity occurs.
Bevacizumab injection
DrugBevacizumab injection (intravenous infusion, 7.5 mg/kg) administered every 21 days as one cycle, for a total of 2 cycles. Radical tumor resection will be performed at least 6 weeks after completion of Bevacizumab treatment.
pathological Complete Response(pCR) rate
Defined as the proportion of patients with no residual viable tumor cells in the primary lesion, as assessed by central laboratory pathologists after surgical resection.
Major pathological response (MPR) rate
Defined as the proportion of patients with ≤10% viable tumor cells in the primary lesion of the surgically resected specimen as assessed by central laboratory pathologists.
Radical resection rate
Defined as the proportion of patients who successfully underwent R0 resection among enrolled patients
Lymph node downstaging rate
Defined as the proportion of patients whose lymph node staging was downgraded after neoadjuvant therapy and surgical treatment, as confirmed by pathological assessment.
Pathological positive lymph node conversion rate
Defined as the proportion of pathologically positive lymph nodes that convert to negative after neoadjuvant therapy, as assessed by pathologists.
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