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Tests treatment safety and results for Non-Small Cell Lung Cancer
Official title 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
ClinicalTrials.gov ID: NCT07034391
What this study is testing
What is denosumab combined anti-PD-1 inhibitor with chemotherapy?
denosumab combined anti-PD-1 inhibitor with chemotherapy is an investigational medicine, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, Liaoning, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.