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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

RECRUITINGPhase 2Sponsored by China Medical University, China
Actively Recruiting
PhasePhase 2
SponsorChina Medical University, China
Started2025-05-12
Est. completion2026-10-31
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07034391

Summary

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

Age: 18 Years – 75 YearsHealthy volunteers accepted
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

Conditions3

CancerLung CancerNon Small Cell Lung Cancer

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