Approximately 25 to 40% of patients with NSCLC have brain metastases (BM) and 3% to 4% develop leptomeningeal metastases (LM). Prognosis for patients with NSCLC and BM or LM is dismal, which seriously affects the quality of life and survival of patients. Several therapeutic options have been applied to manage BM or LM. However, the efficacy is limited. More recently, EGFR-TKIs have shown potential as a treatment option for BM or LM NSCLC patients. Almonertinib (HS-10296), a third-generation EGFR tyrosine kinase inhibitor (TKI), efficiently penetrates the blood brain barrier. This study aims to explore the efficacy and safety of different doses of almonertinib in the first-line and second-line treatment of BM or LM NSCLC patients.
The ARTISTRY study (NCT04778800) was a single-arm, three cohort study. NSCLC patients with EGFR mutations who developed CNS progression are eligible for this study. This trial prepared to enroll approximately 60 patients. For cohort 1, the patients had to have measurable brain lesions and undergone no previous treatment with EGFR-TKI or radiotherapy for brain metastases(n=30). And they will receive oral almonertinib 110 mg/d first and receive 160 mg/d with disease progression in the central nervous system for this group. For cohort 2, the patients had to have LMs confirmed by either CSF cytology or brain MRI and have undergone no previous treatment with EGFR-TKI or radiotherapy for brain metastases(n=10). For cohort 3, the patients have measurable brain lesions whose disease had progressed on first or second-generation EGFR-TKI therapy. For cohort 2 and 3, patients will receive almonertinib 110/160/220 mg/d once daily with a dose-escalation phase if no disease progression was observed in twice consecutive assessments. The primary endpoint is intracranial progression-free survival. Secondary endpoints are progression-free survival, overall survival, intracranial objective response rate, disease control rate, intracranial disease control rate, safety and tolerability.
Clinical trial identification
NCT04778800; 3 March 2021.
Legal entity responsible for the study
Henan Cancer Hospital.
Jiangsu Hansoh Pharmaceutical Co., Ltd.
The author has declared no conflicts of interest.