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

Phase 2

Recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: denosumab combined anti-PD-1 inhibitor with chemotherapy

• Registration Number: NCT07034391
• Lead Sponsor: China Medical University, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-05-12
• Study First Submitted: 2025-05-18
• Study First Submitted QC: 2025-06-22
• Last Update Submitted: 2025-06-22
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Primary Completion: 2026-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
denosumab combined chemotherapy plus anti-PD-1/PD-L1 inhibitor	denosumab combined anti-PD-1 inhibitor with chemotherapy	-

Primary Outcome Measures

Name	Time	Method
6-month PFS rate	6 months	6-month progression-free rate

Secondary Outcome Measures

Name	Time	Method
progression-free survival（PFS）	24 months
overall survival (OS)	24 months
objective response rate (ORR)	6 months
disease control rate (DCR)	6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	24 months

Trial Locations

Locations (1)

The First Affiliated Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China