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.
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
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
Single group
denosumab combined anti-PD-1 inhibitor with chemotherapy
Drug120mg of denosumab，d1 in a 28-days cycle；200mg of anti-PD-1 inhibitor, d1 in a 21-days cycle；500mg/m2 of pemetrexed, d1 in a 21-days cycle; AUC4-5 of carboplatin, d1 in a 21-days cycle, for 4-6 cycle
6-month PFS rate
6-month progression-free rate
progression-free survival（PFS）
overall survival (OS)
objective response rate (ORR)
disease control rate (DCR)
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