Combining PD-1 immunotherapy, denosumab, and chemotherapy for advanced non-squamous lung cancer without targetable mutations
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
Run by China Medical University, China · NCT07034391 · Data updated 2026-11-12
This trial will test whether adding a PD-1 immunotherapy and denosumab to standard chemotherapy helps people with advanced non-squamous non-small cell lung cancer who do not have targetable driver mutations.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | China Medical University, China Academic / other |
| Drugs / interventions | denosumab, chemotherapy, immunotherapy |
| Locations | 1 site (Shenyang, Liaoning) |
| Status | Recruiting |
| Started | May 12, 2025 |
| Main results expected | October 31, 2026 |
| Study ends | October 31, 2027 |
| Registry record updated | June 24, 2025 |
| Trial ID | NCT07034391 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically confirmed locally advanced or metastatic non-squamous NSCLC who are negative for EGFR/ALK/ROS1/BRAFV600E/RET/METex14 mutations, have not received prior systemic therapy for advanced disease, have measurable disease, ECOG 0-1, and adequate organ and marrow function are the intended participants.
✕Probably not a fit
Patients with targetable driver mutations, prior systemic therapy for advanced NSCLC, mixed small-cell/non-small-cell histology, prior use of denosumab or other bone-modifying agents, or poor performance status are unlikely to benefit from this regimen.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 interventional trial gives participants a PD-1/PD-L1 inhibitor together with denosumab and standard chemotherapy to see how well the combination controls locally advanced or metastatic non-squamous NSCLC that lacks common driver mutations. Eligible patients have no prior systemic therapy for advanced disease, measurable disease by RECIST v1.1, ECOG performance status 0-1, and adequate organ function. The trial will monitor tumor responses, disease control, and safety/tolerability during treatment. Outcomes will compare response rates and adverse events to historical expectations for chemotherapy plus immunotherapy.
Why it matters
Potential benefit: If successful, the combination could improve tumor response and disease control for patients without targetable mutations compared with chemotherapy alone.
How similar studies have gone: PD-1 inhibitors combined with chemotherapy have shown benefit in many prior trials, but adding denosumab as an immune-modulating or supportive agent is less tested and remains relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China Recruiting
Study contacts
- Principal investigator: Qu chief physician — First Hospital of China Medical University
- Study coordinator: Zhang Chief Physician
- Email: zhangly1105@126.com
- Phone: 15909881516
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.