The investigators were to explore whether high-dose Furmonertinib, compared with osimertinib, could achieve longer survival in patients with EGFR-mutated NSCLC with CNS metastasis.
Male or female subjects aged >=18 and <=80 years old.
Patients with histologically or cytologically confirmed NSCLC with adenocarcinoma or adenocarcinoma components predominant, and with central nervous system metastases (with measurable lesions).
The tissue or blood sample is determined to be EGFR positive (including rare EGFR mutations) by testing by a tertiary Class A hospital or a qualified testing institution, and the tissue submitted for testing cannot be from a tumor lesion that has been treated with radiation, but can be used for a new lesion after local treatment.
Patients who had not previously received systemic anti-tumor therapy for locally advanced or metastatic non-small cell lung cancer (patients who had received first-line chemotherapy but had not received TKIs could be enrolled). Patients who have undergone radical surgery, radical chemo-radiotherapy, or adjuvant therapy (chemotherapy, radiation) for early NSCLC may be enrolled if they later develop disease recurrence or metastasis.
Previous use of any EGFR TKIs therapy;
Previously received systemic antitumor therapy (such as targeted therapy, biotherapy, immunotherapy, etc.) for advanced/metastatic non-small cell lung cancer;
Standard chemotherapy within 28 days before the first administration of the study drug; The study received anti-tumor therapy with traditional Chinese medicine within 7 days before the first administration of the drug;
Previous WBRT; Had received >30% of bone marrow radiotherapy or extensive radiotherapy within 28 days prior to the first dose of the study drug; Local radiotherapy (e.g., thoracic and rib radiotherapy) or palliative radiotherapy for bone metastases within 7 days prior to initial administration of the study drug;
Parallel
Furmonertinib
DrugFurmonertinib, 160mg po qd
Osimertinib
DrugOsimertinib，80mg po qd
progression free survival(PFS)
The time from the start of randomization until the first occurrence of disease. progression or death from any cause, whichever occurs first.
objective response rate(ORR)
The proportion of patients with a complete or partial response
Intracranial objective Response Rate(iORR)
The proportion of patients with a complete or partial response of intracranial tumors
Intracranial progression free survival(iPFS)
The time from the beginning of randomization to the first occurrence of objective progression or death of intracranial tumors, whichever occurs first.
overal survival time(OS)
The time from randomization to death from any cause
Dynamic changes of ct-DNA
The dynamic changes of ct-DNA in patients' blood before and after 3 weeks of medication
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