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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

RecruitingPhase 2Ages 18 Years - 75 YearsAllChina Medical University, China
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • denosumab combined anti-PD-1 inhibitor with chemotherapy
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Where

1 site
The First Affiliated Hospital of China Medical University
Shenyang, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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