A phase II clinical trial of denosumab treatment for advanced non-small cell lung cancer with bone metastasis
Phase 2
Recruiting
- Conditions
- non-small cell lung cancer
- Registration Number
- JPRN-UMIN000008314
- Lead Sponsor
- Dokkyo Medical University Department of Pulmonary Medicine and Clinivcal Immunology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) Hypersensitivity to denosumab 2) Need of emergency treatment for bone metastasis by radiotherapy or surgery 3) Need of treatment for hypercalcemia 4) Prior use of bisphosphonates 5) Symptomatic brain metastasis 6) Active severe infections 7) Severe odontopathy 8) Interstitial pneumonitis 9) Active concomitant malignancy 10) Pregnant or lactating 11) Uncontrolled heart disease, hepatic disease, diabetes mellitus, bleeding, etc. 12) Problematic psychiatric disease 13) Inappropriate patients for this study judged by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of skeletal-related events (SRE).
- Secondary Outcome Measures
Name Time Method 1) Time to develop SRE 2) Incidence of adverse events 3) Progression free survival 4) Overall survival 5) Response rate 6) Rate of change in bone metabolic markers 7) Rate of change in pain score