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

China Medical University, China

Status and phase

Enrolling

Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: denosumab combined anti-PD-1 inhibitor with chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07034391

QL-NSCLC-LUDX-3001

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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