This study aims to verify the efficacy and safety of osimertinib in patients with EGFR-sensitive mutation non-small cell lung cancer who progressed after adjuvant targeted therapy following radical surgery. The main questions it aims to answer is: whether EGFR-TKI is effective in the re-treatment of NSCLC after postoperative adjuvant targeted therapy relapse.
Aged 18 years or older (inclusive).
Histologically confirmed NSCLC (according to the 8th edition of AJCC lung cancer staging standards).
Subjects must be patients with stage IB-IIIB NSCLC after previous radical surgery, who received adjuvant targeted therapy with EGFR TKIs (first-, second-, or third-generation EGFR TKIs) after surgery, and had tumor recurrence and progression more than 3 months after the end of the adjuvant therapy course.
Tumor tissue samples or blood samples previously diagnosed with NSCLC were confirmed to have EGFR sensitive mutations by qualified laboratory tests.
Patients with only local recurrence and who are suitable for radical chest radiotherapy and chemotherapy.
Patients with any complications or other malignancies who require standard treatment or major surgery within 2 years after the first administration of study treatment.
Severe cardiovascular and cerebrovascular diseases, including but not limited to cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, unstable angina, heart failure ≥ grade II (New York Heart Association (NYHA) classification) within 6 months before enrollment, and severe arrhythmias (including: requiring drug control during the study; the drugs used will interfere with the normal treatment of the study drugs; arrhythmias that cannot be controlled by drugs).
A history of interstitial lung disease, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease.
Jin Ying
Lead sponsor
Zhejiang Cancer Hospital
Sponsor institution