NCT03958565Recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 14 May 2019
- Start date
- 28 Apr 2020
- Primary completion date
- 5 Mar 2028
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Lung cancer
- NCT number
- NCT03958565
What you commit to
- Study type: Observational
- Planned participants: 100
- From 28 Apr 2020 to the primary completion date, 5 Mar 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Actionable driver mutation NSCLC patient who has been on anti-bone resorptive therapy
- Excluded anti-bone resorptive therapy includes: zolendronic acid, pamidronate, alendronate, denosumab or any medication that acts as an osteoclast inhibitor
- 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
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Hospital Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Lone Tree Medical Center Coordinator of this site? Confirm its status | Lone Tree | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.