Phase
Condition
Non-small Cell Lung Cancer
Treatment
denosumab combined anti-PD-1 inhibitor with chemotherapy
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically or cytologically confirmed locally advanced or metastaticnon-squamous non-small cell lung cancer (NSCLC)
Documented negative for EGFR/ALK/ROS1/BRAFV600E/RET/METex14 mutations by validatedgenomic 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
Exclusion Criteria:
Histologically or cytologically confirmed combined small cell and non-small celllung 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 ofthe jaw
Study Design
Connect with a study center
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning 110000
ChinaActive - Recruiting

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