RecruitingNot applicableNCT03958565
Official study title

Response of Bony Metastasis to Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancers With Actionable Driver Mutations.

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedTyrosine Kinase Inhibitor and Zoledronic Acid 4 MG/100 ML Intravenous Solution [ZOMETA]

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 3, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Not applicable

Observational

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?University of Colorado, Denver

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
University of Colorado, Denver
Interventions being studied
Biological: Tyrosine Kinase Inhibitor; Drug: Zoledronic Acid 4 MG/100 ML Intravenous Solution [ZOMETA]; Drug: Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Colorado HospitalAurora, Colorado
  • Lone Tree Medical CenterLone Tree, Colorado

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 3, 2026. Always confirm current availability with the study team.

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