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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

Recruiting
18-75 years
All
Phase 2
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Overview

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

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

Study details
    Non-Small Cell Lung Cancer

NCT07034391

China Medical University, China

16 October 2025

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