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NCT Number: NCT07034391

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location status: Recruiting

Location contact

Zhang chief physician

CONTACT

[email protected]

15909881516

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

denosumab combined anti-PD-1 inhibitor with chemotherapy

Drug

120mg of denosumab，d1 in a 28-days cycle；200mg of anti-PD-1 inhibitor, d1 in a 21-days cycle；500mg/m2 of pemetrexed, d1 in a 21-days cycle; AUC4-5 of carboplatin, d1 in a 21-days cycle, for 4-6 cycle

Primary outcomes

  1. 6-month PFS rate

    Time frame: 6 months

    6-month progression-free rate

Secondary outcomes

  1. progression-free survival（PFS）

    Time frame: 24 months

  2. overall survival (OS)

    Time frame: 24 months

  3. objective response rate (ORR)

    Time frame: 6 months

  4. disease control rate (DCR)

    Time frame: 6 months

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Zhang Chief Physician

CONTACT

[email protected]

15909881516

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Registry information

Official study title

A Phase II Single-Arm 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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