2022 World Conference on Lung Cancer (ePosters)-EP08.02-021. A Phase II Trial of Upfront Aumolertinib (HS-10296) plus Radiotherapy for EGFR Mutated Non-small-cell Lung Cancer Patients with Brain Metastases

EP08.02-021. A Phase II Trial of Upfront Aumolertinib (HS-10296) plus Radiotherapy for EGFR Mutated Non-small-cell Lung Cancer Patients with Brain Metastases

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This study aims to investigate the safety and effectiveness of using a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) called Aumolertinib, in combination with radiotherapy, for non-small-cell lung cancer (NSCLC) patients with brain metastases. EGFR-TKI is a standard treatment for advanced NSCLC patients with EGFR mutations. Aumolertinib has shown promising results in the first-line treatment of EGFR mutated NSCLC patients, with a longer progression-free survival compared to other drugs. Radiotherapy, particularly stereotactic radiosurgery (SRS), is essential for treating a limited number of brain metastases. However, the optimal approach for combining EGFR-TKI and radiotherapy is still unknown.<br /><br />The study plans to enroll 37 patients with advanced NSCLC who have measurable central nervous system (CNS) lesions and EGFR mutations. The patients will take Aumolertinib orally for three months as an induction therapy. After the induction therapy, patients with brain metastases must meet specific criteria on a diagnostic MRI to undergo radiotherapy. SRS treatment will be conducted with a total dose of 30 Gy in five fractions, accompanied by Aumolertinib. For patients with oligometastasis after SRS, stereotactic body radiotherapy (SBRT) will be recommended. Aumolertinib will be continued until disease progression or intolerable toxicity.<br /><br />The primary endpoint of the study is the duration of response in the central nervous system, assessed by specific criteria. Secondary endpoints include intracranial progression-free survival, intracranial and extracranial response rates, overall survival, neurocognitive function, and quality of life. The enrollment of patients started in November 2020 and will last for two years.<br /><br />The study protocol has been approved by the ethics committee of Hangzhou Cancer Hospital and registered on clinicaltrials.gov with the identifier NCT04643847. The inclusion criteria for patients include advanced NSCLC with EGFR mutation, PS 0-2, measurable brain metastases, and a prescribed dose of Aumolertinib for three months. The trial aims to provide insights into the safety and efficacy of combining Aumolertinib with radiotherapy for NSCLC patients with brain metastases.

Asset Subtitle

Yi Tang

Meta Tag

Speaker Yi Tang

Topic Metastatic Non-small Cell Lung Cancer - Molecular Targeted Treatments

Keywords

third-generation epidermal growth factor receptor tyrosine kinase inhibitor

Aumolertinib

radiotherapy

non-small-cell lung cancer

NSCLC

brain metastases

EGFR mutations

progression-free survival

stereotactic radiosurgery

clinical trial