Stage IB-?B EGFR-Positive Non-Small Cell Lung Cancer
Conditions
Interventions
Intervention group:Almonertinib Mesylate Tablets, PO, 110 mg once daily, up to 6 months
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate in this study and sign the informed consent form; 2. Aged >= 18 years, regardless of gender; 3. Patients diagnosed with non-small cell lung cancer (NSCLC) by histopathology or cytology; 4. Patients with resectable stage IB-IIIB NSCLC (assessed according to the 8th edition of the International Association for the Study of Lung Cancer (IASLC) Thoracic Oncology Staging Manual); with confirmed EGFR 19del or L858R mutation positivity in the primary tumor or lymph node metastases; 5. No prior treatment for NSCLC; 6. According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, at least one unidimensionally measurable lesion with the longest diameter >= 10mm as measured by spiral CT; 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 8. Estimated survival time of no less than 12 weeks; 9. Male and female patients of childbearing age agree to use reliable contraceptive methods before entering the trial, during the study, and until 8 weeks after drug withdrawal; 10. Patients who agree to receive surgical treatment; 11. Patients without surgical contraindications as judged by specialist physicians; 12. Normal function of major organs, meeting the following criteria: (1)Pulmonary ventilation function test forced expiratory volume in 1 second (FEV1) >= 1.5L, or predicted FEV1 >= 800ml after lobectomy/pneumonectomy; (2)Blood routine test standards (no blood transfusion or blood products within 14 days, no correction with granulocyte colony-stimulating factor (G-CSF) or other hematopoietic stimulants): 1)Hemoglobin (HB) >= 90g/L; 2)Absolute neutrophil count (ANC) >= 1.5×10^9/L; 3)Platelet (PLT) >= 80×10^9/L; (3)Biochemical test standards: 1)Total bilirubin (TBIL) = 60ml/min; 13. Female patients of childbearing age (15-49 years old) must undergo a urine pregnancy test within 7 days before the start of treatment with a negative result.
Exclusion criteria
Exclusion criteria: 1. Small cell carcinoma, large cell carcinoma, and mixed cell lung cancer; 2. Any prior systemic anticancer treatment for NSCLC, including cytotoxic drug therapy, immunotherapy, investigational therapy, etc.; 3. Prior local radiotherapy for NSCLC; 4. Treatment with systemic immunostimulants (including but not limited to interferon, interleukin-2, tumor necrosis factor) within 4 weeks prior to enrollment or within 5 half-lives of the drug (whichever is longer) (prior use of cancer vaccines is permitted); 5. Use of any Chinese herbal medicine for cancer control within 14 days before the first administration of the study drug; 6. Patients with a history of other cancers (excluding NSCLC) within 5 years before the start of treatment in this study. Exceptions include carcinoma in situ of the cervix, cured basal cell carcinoma, and bladder epithelial tumors; 7. Patients with any severe and/or uncontrolled diseases, including: Poorly controlled blood pressure (systolic blood pressure >= 150 mmHg, diastolic blood pressure >= 100 mmHg),Myocardial ischemia of grade >= I, myocardial infarction, arrhythmia (including QTc >= 480ms), and congestive heart failure of grade >= 2 (New York Heart Association (NYHA) classification), Active or uncontrolled severe infection, Liver cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral treatment, Renal failure requiring hemodialysis or peritoneal dialysis, History of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or organ transplantation, Poorly controlled diabetes mellitus (fasting blood glucose (FBG) > 10 mmol/L),Patients with epilepsy requiring treatment, Long-term unhealed wounds, fractures, etc.; 8. Prior history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring hormone therapy, or any clinically evident active interstitial lung disease; 9. History of arterial/venous thromboembolic events (such as cerebrovascular accident including transient ischemic attack, deep vein thrombosis, and pulmonary embolism) within 6 months; 10. Current peripheral neuropathy of grade >= CTCAE 2 (excluding that caused by trauma); 11. Subjects who have undergone major surgery or suffered severe trauma with less than 14 days of resolution of surgical/traumatic effects before enrollment; 12. Patients currently participating in other clinical studies or with less than 4 weeks since the end of treatment in the previous clinical study; 13. Pregnant or lactating women; 14. Patients with poorly controlled neurological or psychiatric diseases/disorders, poor compliance, and inability to cooperate with or report treatment; 15. Patients judged by the investigator to have other factors that may force early termination of the study, such as other serious diseases, severe laboratory abnormalities, or family/social factors that may affect the subject's safety or the collection of study data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response Rate;Complete Pathological Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Preoperative Objective Response Rate;R0 Resection Rate;Clinical Downstaging Rate;Lymph Node Downstaging Rate;Treatment-Related Adverse Events;2-Year Progression-Free Survival; | — |
Countries
China
Contacts
Public ContactYang Yang
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed