Non-Small Cell Lung Cancer
Conditions
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.
Interventions
DRUGdenosumab 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
Sponsors
China Medical University, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-month PFS rate | 6 months | 6-month progression-free rate |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactZhang Chief Physician
Outcome results
None listed