RecruitingCarcinoma, Non-Small-Cell Lung
Response of Bony Metastasis to Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancers With Actionable Driver Mutations.
Eligible age
18–100 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Colorado, Denver
You may qualify if…
- ✓ 1. Provision to sign and date the consent form
- ✓ 2. Stated willingness to comply with all study procedures and be available for the duration of the study
- ✓ 3. Be a male or female aged 18-100 years
- ✓ 4. Pathologically confirmed non-small cell lung cancer
- ✓ 5. Molecular testing through a CLIA-validated NGS assay. This can be done using either tissue based samples or blood-based samples (ctDNA)
- ✓ 6. ECOG PS 0-2
- ✓ 7. Decision to be on a particular standard of care TKI or chemotherapy +/- immunotherapy (clinical decision that would occur prior to study enrollment)
- ✓ 8. Patients who will be treated with an osteoclast inhibitor must receive dental clearance prior to starting treatment
You may not qualify if…
- ✕ 1. 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
- ✕ 2. 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.
- ✕ 3. Patients with actionable driver mutation who received TKI in past or currently on TKI prior to screening
- ✕ 4. Bone metastases that have received prior radiotherapy unless unequivocal progression has occurred since radiation therapy
Where it's recruiting
Colorado
Aurora · Lone Tree
Source: ClinicalTrials.gov · NCT03958565 · last updated 2026-06-03