Response of Bony Metastasis to Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancers With Actionable Driver Mutations
University of Colorado, Denver
Summary
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.
Description
This is an observational study involving two arms of NSCLC with metastatic bony disease at the time of enrollment in the study. One group will have an actionable driver oncogene and initiate treatment in any line with a TKI as standard of care and concurrent to participation to this study; expected to have an objective response rate in ≥40% who have not previously seen anti-bone resorptive therapy. The other group will not have actionable mutations and initiate treatment with chemotherapy/immunotherapy along with new onset therapy with IV zoledronic acid 4mg Q4 weeks or subcutaneous denosumab…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
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 t…
Interventions
- BiologicalTyrosine Kinase Inhibitor
Targeted therapy given as standard of care.
- DrugZoledronic Acid 4 MG/100 ML Intravenous Solution [ZOMETA]
Given Q4 weeks as standard of care
- DrugDenosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]
Given Q12 weeks for bone disease as standard of care
Locations (2)
- University of Colorado HospitalAurora, Colorado
- Lone Tree Medical CenterLone Tree, Colorado