An Open-label, Single-arm, Phase II Clinical Study of Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Participations will receive the drug treatments preoperatively: Firmonertinib 80mg qd oral for 8 weeks. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment.
Participations will receive the drug treatments preoperatively: Firmonertinib 160mg qd oral for 8 weeks. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment.
Participations will receive the drug treatments preoperatively: Firmonertinib 80mg qd oral for 16 weeks. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment.
Major Pathological Response (MPR) Rate
Defined as the time from the date of surgery to the first occurrence of local or distant disease recurrence, or death from any cause.
Time frame: At the time of surgery (approximately Week 12 from treatment initiation for Cohort 1 and Cohort 2, and Week 20 for Cohort 3), Assessed up to 3 years
Objective Response Rate (ORR)
The percentage of patients who achieve a Complete Response (CR) or Partial Response (PR) based on radiological evaluation (e.g., RECIST v1.1).
Time frame: From baseline up to the pre-operative tumor assessment (at Week 8 for Cohort 1 and Cohort 2, and at Week 16 for Cohort 3). Assessed up to 3 years
Disease Control Rate (DCR)
The percentage of patients who achieve CR, PR, or Stable Disease (SD) based on radiological evaluation (e.g., RECIST v1.1).
Time frame: From baseline up to the pre-operative tumor assessment (at Week 8 for Cohort 1 and Cohort 2, and at Week 16 for Cohort 3). Assessed up to 3 years
Pathological Complete Response (pCR) Rate
The proportion of patients with no remaining viable tumor cells (ypT0N0) in the resected primary tumor and sampled lymph nodes
Time frame: From baseline up to the pre-operative tumor assessment (at Week 8 for Cohort 1 and Cohort 2, and at Week 16 for Cohort 3). Assessed up to 3 years
R0 Resection Rate
The percentage of patients who achieve radical tumor resection with microscopically negative margins (R0 resection) as confirmed by histopathological analysis.
Time frame: At the time of surgery (approximately Week 12 from treatment initiation for Cohort 1 and Cohort 2, and Week 20 for Cohort 3) compared to baseline clinical staging. Assessed up to 3 years
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Pathological Lymph Node Downstaging Rate
The proportion of patients who exhibit a reduction in pathological lymph node stage compared to their pre-treatment clinical staging
Time frame: From baseline up to the pre-operative tumor assessment (at Week 8 for Cohort 1 and Cohort 2, and at Week 16 for Cohort 3). Assessed up to 3 years
Disease-Free Survival (DFS)
Defined as the time from the date of surgery to the first occurrence of local or distant disease recurrence, or death from any cause.
Time frame: From the date of radical surgery up to the date of first documented disease recurrence or death from any cause, assessed up to 3.5 years
Incidence and Severity of Adverse Events (AEs)
The frequency, severity, and types of adverse events, graded and classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: From the first dose of study drug until 28 days after the last dose of study drug, and throughout the perioperative/adjuvant treatment period assessed up to 3.5 years
Incidence of Surgical Complications
The percentage and specific types of surgery-related complications reported in the perioperative phase.
Time frame: Within 30 days following the surgical procedure assessed up to 3.5 years