A randomised, open-label phase III trial evaluating the addition of denosumab to standard first-line anticancer treatment in advanced NSCLC
SPLENDOUR: Survival improvement in lung cancer induced by denosumab therapy
Denosumab is a monoclonal antibody targeting and inhibiting RANKL, a protein that acts as the primary signal for bone resorption. The trial was designed to investigate the potential of denosumab added to standard treatment (chemotherapy) compared to standard treatment alone to increase survival of patients with advanced NSCLC with or without bone metastasis in advanced unselected treatment-naïve patients.
After the excellent initial recruitment, the accrual rate has dramatically slowed down, potentially due to more attractive treatment alternatives for this patient population, in the context of a competitive landscape of ongoing immune-oncology clinical trials. The trial Steering Committee has therefore decided to close the recruitment prematurely. No safety concerns led to this decision.
Trial Scheme
