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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChina Medical University, China

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • denosumab combined anti-PD-1 inhibitor with chemotherapy

Treatment groups

40 Participants
are divided into 1 treatment group