to evaluate the efficacy and safety of gefitinib in adjuvant chemotherapy for lung adenocarcinoma

Conditions: NSCLC; EGFR

Summary: the purpose of this study was to evaluate the efficacy and safety of targeted gefitinib versus oral vinorelbine and carboplatin in egfr-mutant nsclc patients.

the purpose of this study was to evaluate the efficacy and safety of targeted gefitinib versus oral vinorelbine and carboplatin in egfr-mutant nsclc patients. the purpose is to explore the role of tki in neoadjuvant therapy, and to further improve disease-free survival (dfs) and pathologic complete remission (pcr) in egfr-mutant populations; and reduce surgical complications and mortality. objectives: to evaluate the efficacy of oral gefitinib versus neoadjuvant vinorelbine and carboplatin in operable stage ii-iiia egfr-mutant non-squamous nsclc patients, with a 2-year disease-free survival rate. 2ydfs). secondary objective: to evaluate pcr, 0rr, and other efficacy measures (safety, complete) for oral gefitinib vs. neoadjuvant vinorelbine and carboplatin in patients with operable stage ii-iiia egfr-mutant non-squamous cell carcinoma nsclc. resection rate, tumor regression, mediastinal lymph node clearance, perioperative complications, and mortality rate).

Eligibility criteria:
inclusion criteria: 1. the pathological diagnosis is non-squamous cell carcinoma and non-small cell lung cancer. the pre-treatment tumor stage is stage ii-iiia; 2. the gene detects egfr mutations is positive; 3. the age is between 18-70 years; 4. ecog 0-1; 5. liver and kidney function and bone marrow hematopoiesis is normal; 6. there are no serious systemic, respiratory, cardiovascular and other important systemic dysfunctions and severe malnutrition; 7. no other malignant diseases within 5 years; 8. patients who have not received radiotherapy, systemic chemotherapy, or biological therapy; 9. understand the whole process of the trial and voluntarily participate in and sign the informed consent form. exclusion criteria: 1. the tumor has invaded the surrounding tissue; 2. preoperative evidence suggests that distant metastases of the lesion include contralateral mediastinal lymph node metastasis; 3. arrhythmias require anti-arrhythmia therapy (β-blocker or digoxin except), symptomatic coronary artery disease or myocardium. ischemic or congestive heart failure exceeds nyha class ii; 4. severe hypertension with poor drug control; 5. moderate to severe proteinuria; 6. hiv fluhistory of infection or active chronic hepatitis b or c; 7. malnutrition, decompensation of organ function; 8. history of chest radiotherapy; 9. incomplete inflammation of eyes; 10. patients with seizures that need to be treated; 11. interstitial pneumonia; 12. drug abuse and others that may interfere with patients' participation in the study or studythe assessment of the results has an impact; 13. allergies to the study drug are known or suspected to be allergic to or administered to any drug associated with this test; 14. any instability. the condition of the patient may jeopardize patient safety and compliance; 15. pregnancy or breastfeeding women and having fertility without adequate contraception.

Keywords: egfr nsclc carboplatin vinorelbine gefitinib