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
NCT ID: NCT07034391
Last Updated: 2025-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2025-05-12
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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denosumab combined chemotherapy plus anti-PD-1/PD-L1 inhibitor
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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China Medical University, China
OTHER
Responsible Party
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Xiujuan Qu
Chief Physician
Principal Investigators
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Qu chief physician
Role: PRINCIPAL_INVESTIGATOR
First Hospital of China Medical University
Locations
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The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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QL-NSCLC-LUDX-3001
Identifier Type: -
Identifier Source: org_study_id
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