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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: denosumab combined anti-PD-1 inhibitor with chemotherapy.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Single-Arm 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
Overview
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.
Interventions
- Drug 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
Primary outcome measures
- 6-month PFS rate [Time frame: 6 months]
Secondary outcome measures (5)
- progression-free survival（PFS） [Time frame: 24 months]
- overall survival (OS) [Time frame: 24 months]
- objective response rate (ORR) [Time frame: 6 months]
- disease control rate (DCR) [Time frame: 6 months]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time frame: 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of China Medical University — Shenyang
Identifiers
NCT: NCT07034391 · QL-NSCLC-LUDX-3001