Response of Bony Metastasis to Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancers With Actionable Driver Mutations.
Recruiting · NCT03958565 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Colorado, Denver
View the official record on ClinicalTrials.gov →Interventions studied
Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]Tyrosine Kinase InhibitorZoledronic Acid 4 MG/100 ML Intravenous Solution [ZOMETA]
What this trial is about
The purpose of this study is to assess percentage reduction in the of urine NTX and serum CTX , in patients with NSCLC and bone metastases 1) with actionable driver oncogene on standard of care (SOC) TKI at 3 months post treatment and 2) without actionable mutations on standard of care therapy (chemotherapy/immunotherapy) treated with zoledronic acid or denosumab at the same time period.
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Provision to sign and date the consent form
- Stated willingness to comply with all study procedures and be available for the duration of the study
- Be a male or female aged 18-100 years
- Pathologically confirmed non-small cell lung cancer
- Molecular testing through a CLIA-validated NGS assay. This can be done using either tissue based samples or blood-based samples (ctDNA)
- ECOG PS 0-2
- Decision to be on a particular standard of care TKI or chemotherapy +/- immunotherapy (clinical decision that would occur prior to study enrollment)
- Patients who will be treated with an osteoclast inhibitor must receive dental clearance prior to starting treatment
- Bone metastases must be detected through radiographic imaging prior to enrollment on this study.
Exclusion criteria
- Actionable driver mutation NSCLC patient who has been on anti-bone resorptive therapy
- a. Excluded anti-bone resorptive therapy includes: zolendronic acid, pamidronate, alendronate, denosumab or any medication that acts as an osteoclast inhibitor
- Have any condition or illness that, in the opinion of the investigator, would compromise participant safety or interfere with evaluation while on standard of care treatments for the NSCLC.
- Patients with actionable driver mutation who received TKI in past or currently on TKI prior to screening
- Bone metastases that have received prior radiotherapy unless unequivocal progression has occurred since radiation therapy
Where it is running
2 locations listed across 1 US state.
- University of Colorado Hospital - Aurora, Colorado, United States
- Lone Tree Medical Center - Lone Tree, Colorado, United States