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
Recruiting · NCT07034391 · Interventional (participants receive a specific treatment) · Lead sponsor: China Medical University, China
View the official record on ClinicalTrials.gov →Interventions studied
denosumab combined anti-PD-1 inhibitor with chemotherapy
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
1 location listed.
- The First Affiliated Hospital of China Medical University - Shenyang, Liaoning, China