The Feasibility of Dynamic Liquid Biopsy Monitoring During Neoadjuvant Treatment for EGFR-mutated NSCLC

Prior treatment

• Patients who are using immunosuppressive agents or require systemic hormone therapy

Other illness

• Patients with other primary malignancies within the past 3 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ)
• Patients with active hepatitis B/C
• Patients with any active autoimmune diseases or a history of autoimmune diseases
• Patients with hypertension but without good control even through antihypertensive medication treatment ; patients with clinical symptoms or diseases related to unsatisfying cardiac function
• Patients with active infection
• Patients with congenital or acquired immune dysfunction (such as HIV infection)

Lab values

• Patients with abnormal coagulation function (INR\>2.0, PT\>16s)

Other

• Arterial/venous thrombotic events occurred before screening within 6 months
• According to the judgment of the researchers, patients have other factors that may affect the results of the research or cause the research to be terminated

• Patients should voluntarily join this study and sign the informed consent form
• Patients diagnosed with resectable stage II-IIIB (T1-4N0-2M0, excluding T4 with invasion of vital structures and bulky or infiltrative N2) NSCLC
• Patients with EGFR 19del or L858R mutations.
• Age from 18 to 75 years old, both male and female
• ECOG score 0-1
• According to the RECIST v1.1 , patients should have at least one measurable lesion
• For suspicious mediastinal lymph nodes (including pathological enlargement or PET-CT indicating malignancy, etc.), further sampling is required for pathological diagnosis by EUBS, thoracoscopy, or mediastinoscopy
• According clinical evaluation, the lung function of patients (such as FVC, FEV1, TLC, FRC, DLco, etc.) should be sufficient for pneumonectomy
• The function of important organs should meet the following requirements: absolute count of neutrophils ≥ 1.5 × 109/L# Platelets
  • ≥ 100 × 109/L# Hemoglobin ≥ 90g/L; Serum albumin ≥ 35g/L; Thyroid hormone (TSH) ≤ 1 × ULN# Serum bilirubin ≤ 1.5 × ULN# ALT and AST ≤ 3 × ULN# International standardized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN# Serum creatinine ≤ 1.5 × ULN
• Female patients at childbearing age are required to use contraceptive measures; for male patients whose partners are women at childbearing age, effective methods of contraception should be used during the trial period