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Response of Bony Metastasis to Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancers With Actionable Driver Mutations.
Response of Bony Metastasis to Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancers With Actionable Driver Mutations
Who can join
Ages 18 to 100 · All sexes
Full eligibility criteria
Inclusion Criteria: 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 9. Bone metastases must be detected through radiographic imaging prior to enrollment on this study. Exclusion Criteria: 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
About the 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.
What is being tested
- Tyrosine Kinase Inhibitor (biological)
- Zoledronic Acid 4 MG/100 ML Intravenous Solution [ZOMETA] (drug)
- Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA] (drug)
Sponsor: University of Colorado, Denver · Participants: 100 · Started: Apr 28, 2020
Contact the study team
- Febin Elias · Phone: 13037249459
Official record on ClinicalTrials.gov — NCT03958565
Locations in the U.S.
| Colorado | University of Colorado Hospital, Aurora Lone Tree Medical Center, Lone Tree |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.