118TiP A multicenter, randomized, double-blind, placebo-controlled phase III trial of camrelizumab plus chemotherapy with or without radiation therapy (RT) as first-line treatment for patients with brain metastatic non-small cell lung cancer (BM-NSCLC; CTONG2003): Trial in progress

At diagnosis, 10%-15% NSCLC patients have brain metastases. BM-NSCLC suffer worse prognosis. For BM-NSCLC, local therapies, e.g., surgery and radiation therapy, are the mainstream of treatment. Immunotherapy combined with or without chemotherapy is first-line standard of care for NSCLC. Immunotherapy showed trends for benefit in BM-NSCLC and a synergistic effect with radiation therapy. However, there is a lack of high-quality evidence on additional immunotherapy on chemotherapy for BM-NSCLC. The present phase III trial aims to confirm camrelizumab, an anti-programmed cell death protein-1 antibody, plus chemotherapy with or without stereotactic or whole brain RT as first-line treatment for BM-NSCLC without driver gene mutation.