Clareo Health | A Study Evaluating the Efficacy of PD-1 Inhibitor Combined With Denosumab and Chemotherapy in Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Patients With Driver Gene-Negative Status
A Study Evaluating the Efficacy of PD-1 Inhibitor Combined With Denosumab and Chemotherapy in Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Patients With Driver Gene-Negative Status
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
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
No use of parathyroid hormone/derivatives, calcitonin, osteoprotegerin, mithramycin, or potassium supplements within the past 6 months
Adequate organ and marrow function
You may not be if
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
History or current evidence of osteonecrosis of the jaw (ONJ) or osteomyelitis of the jaw