Befotertinib Adjuvant Therapy in Stage IA2-IB NSCLC Patients
- Conditions
- 3-year Disease-free Survival
- Registration Number
- NCT06561620
- Lead Sponsor
- Fudan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Age: 18-75 years old.<br><br> 2. Gender: both men and women are acceptable, as balanced as possible.<br><br> 3. Patients with lung adenocarcinoma who underwent R0 resection and were clinically<br> confirmed as IA2-IB by histopathology and whose tumor size was (1-4cm), the surgical<br> tissue samples tested positive for EGFR-sensitive mutations and positive for MRD<br> after surgery.<br><br> 4. Accompanied by arbitrary = 2 high-risk factors; High risk factors such as pleural<br> invasion, airway diffusion, vascular infiltration, low differentiation, pathological<br> micropapillary composition = 15%, complex glandular composition = 20%, etc.<br><br> 4. Achieve R0 resection: For CTR < 50% ground glass nodules, wedge resection is<br> acceptable and the margin is negative, and 3 groups of lymph node biopsies are<br> negative; for CTR = 50% or pure solid nodules, at least segmental resection is<br> undergone, and lymph node dissection is systematically performed; if there is no<br> clear evidence of metastasis, if it cannot be judged, it can be determined by an<br> independent review committee for pathological consultation.<br><br> 5. The ECOG behavioral status score is 0 to 1, and the expected survival time is > 1<br> year.<br><br> 6. Voluntary MRD screening and voluntary befortinib adjuvant therapy; 7. Have a certain<br> organ system function, defined as follows, based on the researcher's experience A.<br> Absolute neutrophil count (ANC) = 1.5 x 109/L B. Platelets = 100 x 109/L; C.<br> Hemoglobin = 9 g/dL (= 90 g/L) Note that in order to achieve the required hemoglobin<br> level, blood transfusion is allowed; D. Total bilirubin = 1.5 times the upper limit<br> of normal (ULN); E. If there is no liver metastasis, alanine aminotransferase (ALT)<br> and aspartate aminotransferase (AST) = 2.5 × ULN; if liver metastasis, = 5 × ULN; F.<br> Creatinine = 1.5 x ULN. Patients are still eligible for inclusion if the creatinine<br> clearance value calculated by the Cockcroft-Gault method is = 50 mL/min (0.83 mL/s).<br><br> 8. Female subjects of childbearing age must have a serum pregnancy test within 3 days<br> before the start of the study drug, and the result is negative, and they are willing<br> to use a medically approved high-efficacy contraceptive method (such as intrauterine<br> devices, contraceptives or condoms) during the study period and within 3 months<br> after the last administration of the study drug; for significant other male subjects<br> who are women of childbearing age, they should be surgically sterilized, or agree to<br> use effective methods of contraception during the study period and within 3 months<br> after the last study dose.<br><br> 9. Voluntary and capable of following the test and follow-up procedures. 10. Sign the<br> informed consent form.<br><br>Exclusion Criteria:<br><br> 1. There is any other treatment before the operation, and no informed consent is<br> signed;<br><br> 2. The patient has been diagnosed with cancer within 2 years;<br><br> 3. Have a history of interstitial lung disease, drug-induced interstitial disease or<br> any active interstitial lung disease with clinical evidence; CT scan at baseline<br> revealed idiopathic pulmonary fibrosis.<br><br> 4. Patients who are known to be allergic to any component of befortinib or similar<br> drugs;<br><br> 5. Pregnant or lactating women;<br><br> 6. Situations considered unsuitable for inclusion by other researchers.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-year disease-free survival
- Secondary Outcome Measures
Name Time Method