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.
Single group
Osimertinib mesylate
DrugOsimertinib mesylate , 80mg QD，until the duration of treatment reaches 3 years, the disease progresses, or other treatment termination criteria are met
Objective remission rate evaluated by the investigator (ORR)
Objective Response Rate (ORR) (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments) is defined as the number (%) of patients with at least 1 visit response of Complete Response or Partial Response.
Progression-free survival (PFS) evaluated by the investigator
Progression-free survival (PFS) is defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression.
Duration of response (DoR) evaluated by the investigator
Duration of Response is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
Disease control rate (DCR) evaluated by the investigator
Disease control rate (DCR) is defined as the percentage of subjects who have a best overall response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the Investigator.
Overall survival (OS) evaluated by the investigator
Overall survival is defined as the time from the date of randomization until death due to any cause.
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Jin Ying
Lead sponsor
Zhejiang Cancer Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
