Phase 2 Study of Brain Radiotherapy Combined with PD-1PD-L1 Inhibitors and Chemotherapy in Patients with Untreated Non-Small Cell Lung Cancer Without Driver Mutations and Active Brain Metastases

What this Trial Is About

Non-small cell lung cancer NSCLC is the most common type of lung cancer and often spreads to the brain, causing brain metastases BM. Historically, patients with advanced NSCLC and BM had a median survival under six months with chemotherapy. Recent advances with immune checkpoint inhibitors ICIs, especially when combined with chemotherapy, have shown promise in improving response rates and survival. However, challenges like treatment resistance and recurrence persist, highlighting the need for better treatments. This phase 2 study focuses on combining brain radiotherapy with PD-1PD-L1 inhibitors and chemotherapy in patients with untreated NSCLC without driver gene mutations who have active brain metastases. Participants with active brain metastases will receive a combination of PD-1PD-L1 inhibitors and chemotherapy alongside stereotactic radiotherapy SRT or whole brain radiation therapy WBRT, depending on individual brain metastasis conditions. The study aims to assess the safety and effectiveness of this combined approach, which recent data suggest may improve local control and survival while maintaining safety. This treatment plan targets patients who have not received prior therapy and have brain lesions larger than 5mm. During the study, patients will undergo thorough baseline assessments including enhanced brain MRI and systemic lesion evaluation before treatment begins. Researchers will monitor overall survival, response rates, progression-free survival, and treatment-related side effects over one year. The study involves careful safety monitoring and ongoing evaluations to understand how well the combination therapy controls brain metastases and overall disease, with a goal to improve outcomes in this challenging patient group.

Cranial Radiotherapy Plus Chemoimmunotherapy in Untreated Driver-mutation Negative NSCLC With Active Brain Metastasis