An Observational Study of Furmonertinib for EGFR Mutation-positive NSCLC Patients With Brain Metastasis

Summary

EGFR mutation positive advanced NSCLC patients with CNS metastases were associated with poor prognosis. Furmonertinib showed promising CNS efficacy in doses of 80 mg orally once daily or higher in patients with EGFR T790M mutation positive NSCLC. This study aims to investigate the efficacy and safety of furmonertinib in the treatment of EGFR-sensitive mutation positive NSCLC patients with brain metastasis.

Eligibility

Inclusion Criteria:

1. at least 18 years of age;
2. Histologically or cytologically confirmed metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC);
3. Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically.( EGFR L858R or Del 19 with/without T790M )
4. Imaging (MR/CT) confirmed untreated brain metastases before Furmonertinib initiation;
5. Organ function is compatible with oral Furmonertinib therapy (investigator determination based on real-world practice);
6. Life expectancy ≥12 weeks before Fumonertinib initiation;
7. ECOG PS of 0 to 2;
8. Sign the informed consent form.

Exclusion Criteria:

1. Any Third-Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) before Furmonertinib initiation;
2. Known hypersensitivity to Furmonertinib or its excipient components;
3. Simultaneous systemic chemotherapy or WBI;
4. The time from the treatment with any other investigational product or its analogue before Furmonertinib initiation does not exceed 5 half-lives of the drug or 14 days, whichever is longer;
5. Any evidence of severe or uncontrolled systemic diseases;
6. Presence of any disease that may strongly interfere with oral drug absorption; presence of any factor that contributes to QTc prolongation or increased risk of arrhythmia; presence of interstitial pneumonitis.

Conditions4

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