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

Last updated: June 22, 2025
Sponsor: China Medical University, China
Overall Status: Active - Recruiting

Phase

2

Condition

Non-small Cell Lung Cancer

Treatment

denosumab combined anti-PD-1 inhibitor with chemotherapy

Clinical Study ID

NCT07034391
QL-NSCLC-LUDX-3001
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed locally advanced or metastaticnon-squamous non-small cell lung cancer (NSCLC)

  • Documented negative for EGFR/ALK/ROS1/BRAFV600E/RET/METex14 mutations by validatedgenomic 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

Exclusion Criteria:

  • Histologically or cytologically confirmed combined small cell and non-small celllung 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 ofthe jaw

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: denosumab combined anti-PD-1 inhibitor with chemotherapy
Phase: 2
Study Start date:
May 12, 2025
Estimated Completion Date:
October 31, 2027

Connect with a study center

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning 110000
    China

    Active - Recruiting

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