Denosumab and Nivolumab Combination as 2d-line Therapy in Stage IV NSC Lung Cancer With Bone Metastases (DENIVOS)
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
Bone metastases are common in Non-Small Cell Lung Cancer (NSCLC). They most often occur
during disease progression. It is thought that more than half of the patients with bone
metastases will have at least 1 skeletal-related event (SRE, i.e. pathological fractures,
medullary compression, analgesic radiotherapy, preventive and/or analgesic surgery and
hypercalcemia).
Expert and medical Society guidelines, notably European Society for Medical Oncology in 2014,
then in 2016, recommended using anti-resorptive agents (bisphosphonates or denosumab) to
prevent SREs, attenuate pain and improve the quality of life, and decrease the
medical-economic impact of this major metastatic site. Denosumab was accorded marketing
authorization in France in 2011 as an anti-resorptive agent for bone metastases to delay the
occurrence of SREs in lung-cancer patients.
Immunotherapy, notably immune-checkpoint inhibitors, like nivolumab (anti-programed death-1),
has recently become an integral part of the therapeutic arsenal against NSCLCs. Nivolumab was
accorded marketing authorization based on the phase III CHECKMATE 017 (squamous cell NSCLCs)
and CHECKMATE 057 (non-squamous cell NSCLCs) trials versus docetaxel, after the phase II
CHECKMATE 063 trial.
The denosumab-nivolumab combination is commonly used in current practice but has not been
evaluated prospectively. The aim of this trial is to evaluate the combination of denosumab
and nivolumab in second line of NSCLC with bone metastases.
Phase:
Phase 2
Details
Lead Sponsor:
Centre Hospitalier Annecy Genevois Centre Hospitalier de la Région d'Annecy