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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Firmonertinib 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 (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.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
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.
Time frame: Within 24 hours 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.
Time frame: Within 7 days after surgical resection
Radical resection rate
Defined as the proportion of patients who successfully underwent R0 resection among enrolled patients
Time frame: Within 7 days after surgical resection
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.
Time frame: Within 7 days after completion of neoadjuvant therapy and within 7 days after surgical resection
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.
Time frame: Within 7 days after completion of neoadjuvant therapy and within 7 days after surgical resection
Objective response rate (ORR) by investigator
Defined as the proportion of patients who achieved complete response or partial response after 9 weeks following the first dose of Firmonertinib, as assessed by investigator using Computed Tomography (CT) scans according to RECIST 1.1 criteria.
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Time frame: Approximately 9 weeks following the first dose of Firmonertinib
Event-free survival (EFS)
Defined as the time from the first administration of study treatment to the occurrence of an event or death, whichever occurs first. Events include documented disease progression that prevents surgery or necessitates non-protocol-specified treatment; local or distant disease recurrence or new lesions (pathologically confirmed new primary malignancies are not considered EFS events).
Time frame: From first dose until the event of interest, assessed up to 36 months after the first dose
Safety: Occurrence and frequency of adverse events, severity, surgical complications
Occurrence and frequency of adverse events, severity, surgical complications
Time frame: From randomization to 30 days after treatment completion
Patient-reported outcomes: Change from European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30)
Assessed using EORTC QLQ-C30 to evaluate patient symptoms and overall quality of life. Unit of Measure: Score on a 0-100 scale Range: 0 = Worst; 100 = Best (Higher score indicates better quality of life)
Time frame: Day1/21/42/63/84 of Neoadjuvant Therapy
Patient-reported outcomes: Change from European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13(QLQ-LC13)
Assessed using EORTC QLQ-LC13 to evaluate patient symptoms and overall quality of life. Unit of Measure: Score on a 0-100 scale Range: 0 = Worst; 100 = Best (Higher score indicates better quality of life)
Time frame: Day1/21/42/63/84 of Neoadjuvant Therapy