II-IIIB EGFR-mutated resectable non-small cell lung cancer
Conditions
Interventions
treatment group:Firmonertinib 160mg, PO, QD, for 8 weeks
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Written informed consent was obtained from the patients before any examination or analysis related to the study was conducted. 2. Male or female, aged >=18 years. 3. Histologically or cytologically confirmed primary non-small cell lung cancer within 60 days prior to study enrollment. 4. For stage II-IIIB disease assessed by EBUS-TBNA, mediastinoscopy, or PET/CT, radical resection after neoadjuvant therapy is expected. 5. EGFR mutation-positive (19Del or L858R mutation, with or without other EGFR mutations) as detected by local laboratory tissue or blood testing . 6. The presence of at least one measurable lesion with a longest diameter >=10 mm on baseline CT scan and suitable for accurate repeated measurement. 7. ECOG performance status score 0-1, with no deterioration within 2 weeks before the first dose. 8. Female patients must use highly effective contraception, refrain from breastfeeding, and have a negative pregnancy test prior to the first dose of the study drug; OR, at the time of screening, must meet one of the following criteria to confirm non-childbearing potential: a) Postmenopausal, defined as age 50 years or older and amenorrhoea for at least 12 months after cessation of all exogenous hormone therapy. b) Women younger than 50 years of age are considered postmenopausal if they have amenorrhoea for 12 months or more after cessation of exogenous hormone therapy and their luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the postmenopausal range. c) Documented irreversible surgical sterilization, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, excluding tubal ligation. 9. Male patients should be willing to use barrier contraception, such as condoms.
Exclusion criteria
Exclusion criteria: 1. The presence of small cell lung cancer or NSCLC with mixed pathological types. 2. Prior exposure to any antitumor therapy, including perioperative radiotherapy, before enrollment is excluded. 3. The patient is pregnant or breastfeeding. 4. Patients with a history of other malignant tumors or currently suffering from other malignant tumors (except for malignant tumors that have undergone radical surgery and have not recurred for 5 years after surgery, such as cervical carcinoma in situ, basal cell carcinoma of the skin, and papillary thyroid carcinoma). 5. Patients with severe or uncontrolled systemic diseases requiring treatment who are deemed unsuitable for trial participation by the investigators, including hypertension, diabetes, chronic heart failure (NYHA functional class III-IV), unstable angina, myocardial infarction within 1 year, etc.; patients with active infection requiring intravenous treatment. 6. Severe gastrointestinal dysfunction, diseases or clinical conditions that may affect the intake, transport or absorption of study drugs, such as inability to take oral medications, uncontrollable nausea and vomiting, history of extensive gastrointestinal resection, etc. 7. Any of the following laboratory tests indicates inadequate bone marrow reserve or organ reserve. a) Absolute neutrophil count 2.5 × upper limit of normal (ULN) e) Aspartate aminotransferase (AST) >2.5 × ULN f) Total bilirubin >1.5 × ULN or >3 × ULN in the presence of Gilbert's syndrome (unconjugated hyperbilirubinemia). 8. Patients who are known or suspected to be allergic to Firmonertinib or other ingredients of its preparations, or have other contraindications. 9. If the patient is unable to comply with the study procedures, restrictions and requirements, or the researcher believes that the patient is not suitable or suitable to participate in the study. 10. Patients who are currently or have previously participated in any other anti-tumor clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological response rate;TNM downstaging rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;R0 resection rate;Objective response rate;Safety; | — |
Countries
China
Contacts
Public ContactWeiming Yue
Qilu Hospital of Shandong University
Outcome results
None listed