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 | Recruiting Phase 2

• 1 other identifier: QL-NSCLC-LUDX-3001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 6-month PFS rate

  6-month progression-free rate

  6 months

Secondary Outcomes (5)

• 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

Study Arms (1)

denosumab combined chemotherapy plus anti-PD-1/PD-L1 inhibitor

EXPERIMENTAL

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

Interventions

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

denosumab combined chemotherapy plus anti-PD-1/PD-L1 inhibitor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Qu chief physician

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhang Chief Physician

CONTACT

15909881516; zhangly1105@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: June 24, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-03

Locations

CN (1)