2022 World Conference on Lung Cancer (ePosters)-EP08.01-029. NIVIPI-BRAIN, A Phase II Study of Nivolumab plus Ipilimumab Combined with Chemotherapy for Patients with NSCLC and Synchronous Brain Metastases

EP08.01-029. NIVIPI-BRAIN, A Phase II Study of Nivolumab plus Ipilimumab Combined with Chemotherapy for Patients with NSCLC and Synchronous Brain Metastases

Back to course

Pdf Summary

The NIVIPI-BRAIN trial is a phase II study investigating the safety and effectiveness of a combination treatment in patients with advanced non-small cell lung cancer (NSCLC) and synchronous brain metastases (BM). Brain metastases are a common complication of NSCLC and can negatively impact quality of life and prognosis.<br /><br />The trial is assessing the combination of two cycles of chemotherapy with ipilimumab and nivolumab in this patient population. The primary endpoint of the study is the rate of intracranial clinical benefit, defined as the percentage of patients who do not progress in the brain for at least 6 months. Secondary endpoints include overall response rate, progression-free survival, duration of response, safety, overall survival, and quality of life.<br /><br />The study aims to enroll a total of 71 patients, with 22 patients already included in the trial. Key inclusion criteria for patients include stage IV NSCLC with no prior systemic therapy or brain radiotherapy, measurable disease in the brain and systemic organs, Eastern Cooperative Oncology Group performance status of 0-1, and adequate organ function.<br /><br />Exclusion criteria include previous malignant disease within the past 3 years, certain types of brain metastases, neurological symptoms, certain mutations or fusions, autoimmune disease, active severe infection, and pregnancy or breastfeeding.<br /><br />The statistical considerations of the trial aim to show that the experimental treatment will achieve a disease control rate of at least 50% at 6 months. The trial is being conducted at 18 participating sites.<br /><br />Overall, the NIVIPI-BRAIN trial seeks to determine the safety and efficacy of the combination treatment in patients with advanced NSCLC and untreated brain metastases.

Asset Subtitle

Ernest Nadal

Meta Tag

Speaker Ernest Nadal

Topic Metastatic Non-small Cell Lung Cancer - Immunotherapy

Keywords

NIVIPI-BRAIN trial

phase II study

non-small cell lung cancer

synchronous brain metastases

combination treatment

chemotherapy

ipilimumab

nivolumab

intracranial clinical benefit

progression-free survival