This study is a patient-centered, two-group, three-cohort, multi-center, prospective study to further evaluate the survival benefits and safety of zorifertinib as a first-line treatment in EGFRm+ advanced NSCLC patients with CNS metastases, and to compare the clinical value of zorifertinib with other epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs).
Male or female, aged ≥18 years.
Histologically or cytologically confirmed NSCLC with EGFR sensitizing mutations (including L858R or Exon 19Del), ineligible for curative surgery or radiotherapy.
CNS metastases diagnosed as brain metastases (BM) and/or leptomeningeal metastases (LM) by imaging and/or cerebrospinal fluid pathological examination.
Planning to receive zorifertinib (zorifertinib group) or other anti-tumor treatments (other treatment group) as first-line treatment.
Currently participating or planning to participate in any interventional clinical study for first-line treatment (patients who have participated in non-interventional, real-world studies may still be included).
Other reasons that, in the Investigator's opinion, make the patient unsuitable for this study.
. No prior treatment with chemotherapy, EGFR-TKIs, biological therapy, immunotherapy, or any investigational drug that is considered first line treatment for advanced NSCLC.
. Eligible patients are not candidates for definitive surgical resection or radiation of all lesions in the opinion of the treating physician.
Patients with advanced non-small cell lung cancer (NSCLC) who have been diagnosed with epidermal growth factor receptor mutation type (EGFRm+) and have central nervous system (CNS) metastasis
Cohort
Prospective
zorifertinib
DrugCohort A and B will receive zorifertinib as first line treatment
Overall Survival (OS)
The period from the first administration date of the study treatment to the date of death due to any cause.
Incidence of Adverse Events (AEs) for zorifertinib
All adverse events were classified according to the CTCAE (version: 5.0)
Incidence of Dose Adjustments for zorifertinib
The dose adjustments during the treatment by zorifertinib
Progression-free survival (PFS)
Investigator conducted the assessment based on RECIST 1.1
intracranial Progression-free survival (iPFS)
Investigator conducted the assessment based on RECIST 1.1
The progression-free survival period of the zorifertinib treatment group (PFS2)
The period from the first administration date of the study treatment to the date of disease progression or death in the second-line treatment（Just for the zorifertinib treatment group ). Investigator conducted the assessment based on RECIST 1.1
The Genetic Resistance Status
Conduct genetic testing when disease progression occurs during the first-line zorifertinib treatment.
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