Clinical trial · Interventional
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
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
NCT07034391CI-TRIAL-00091285recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| denosumab combined anti-PD-1 inhibitor with chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- denosumab combined chemotherapy plus anti-PD-1/PD-L1 inhibitor
- interventionNames
- Drug: denosumab combined anti-PD-1 inhibitor with chemotherapy
Primary outcomes (1)
- measure
- 6-month PFS rate
- timeFrame
- 6 months
- description
- 6-month progression-free rate
Secondary outcomes (5)
- measure
- progression-free survival（PFS）
- timeFrame
- 24 months
- measure
- overall survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.