Abstract 1371TiP
Background
Brain is one of the most common sites of distant metastasis from lung cancer. Patients with brain metastasis (BM) from lung cancer have a poor prognosis, with a natural mean survival time of only 1-2 months. Radiotherapy is the cornerstone of the treatment of brain metastases in patients with non-small cell lung cancer (NSCLC), which can improve the survival rate and reduce the local recurrence rate. At present, the vast majority of prospective clinical studies on lung cancer immunotherapy have excluded patients with BM. Some retrospective studies have shown the efficacy of programmed cell death protein 1 (PD-1) inhibitors in the treatment of lung cancer brain metastasis. The efficacy of immunotherapy in lung cancer brain metastasis remains to be explored and confirmed. Several studies have shown the efficacy of antiangiogenic therapy in lung cancer with brain metastasis. However, the safety and efficacy of radiotherapy combined with immunotherapy and antiangiogenic therapy of BMs remains unclear. Therefore, this study was conducted to explore its efficacy.
Trial design
This study is a single-arm exploratory clinical study, which is expected to enroll 42 patients with wild type NSCLC with BM from April 2021 to April 2023, and will be treated with brain radiotherapy combined with apatinib (antiangiogenic drugs against vascular endothelial growth factor receptor-2) and PD-1 inhibitors. The primary end points were intracranial progression-free time (refer to the immunotherapy Response Assessment in Neuro-Oncology (iRANO) standard). The secondary endpoints were: intracranial objective response rate (IORR), objective response rate (ORR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), quality of life score (QOL), and safety. The exploratory endpoints were neurocognitive function status (Mini-mental State Examination and Neurologic Assessment in Neuro-Oncology scale) and edema index. Expectation: This study is expected to provide new treatment options for patients with brain metastases from advanced non-small cell lung cancer and bring new hope.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The author.
Funding
Has not received any funding.
Disclosure
The author has declared no conflicts of interest.