About this trial
This is an interventional study to explore the efficacy and safety of denosumab combined chemotherapy and anti-PD-1/PD-L1 inhibitor in locally advanced or metastatic NSCLC.
Eligibility criteria
Qualifiers
Histologically or cytologically confirmed locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)
Documented negative for EGFR/ALK/ROS1/BRAFV600E/RET/METex14 mutations by validated genomic testing, with no prior targeted therapy and no history of other malignancies
No previous systemic therapy for advanced/metastatic disease
At least one measurable lesion per RECIST v1.1
Disqualifiers
Histologically or cytologically confirmed combined small cell and non-small cell lung cancer (mixed histology)
Any previous systemic anticancer treatment for NSCLC, including chemotherapy, biologics, immunotherapy, or investigational agents
Prior use of denosumab or any bone-modifying agents (e.g., bisphosphonates)
Uncontrolled hypocalcemia or hypophosphatemia
Trial design
Treatments tested in this trial
- denosumab combined anti-PD-1 inhibitor with chemotherapy