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

NCT07034391 · tracked via the Priya Life Science China tracker

Sponsor

China Medical University, China

Phase

Phase 2

Started

2025-05-12

Last updated

2025-06-24

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

denosumab combined anti-PD-1 inhibitor with chemotherapy

denosumab combined anti-PD-1 inhibitor with chemotherapy: 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

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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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

Primary outcome measure(s)

6-month PFS rate — 6 months
6-month progression-free rate

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of China Medical University	Shenyang	Liaoning	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07034391 on ClinicalTrials.gov ↗ ← All trials in China