Recruiting

Tyrosine Kinase Inhibitors

Sponsor:

University of Colorado, Denver

Code:

NCT03958565

Conditions

Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tyrosine Kinase Inhibitor

Zoledronic Acid 4 MG/100 ML Intravenous Solution [ZOMETA]

Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]

Study Details

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study ID

NCT03958565

Start date

Apr 28, 2020

Status verified date

Jun, 2026

Completion date

Apr 28, 2028

Anticipated

Primary completion date

Mar 5, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Actionable driver oncogene

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.

No Actionable Mutations

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 120 mg Q12 weeks for bone disease, which is standard of care and would be concurrent to participation in this study.

Interventions

Tyrosine Kinase Inhibitor

Targeted therapy given as standard of care.

Zoledronic Acid 4 MG/100 ML Intravenous Solution [ZOMETA]

Given Q4 weeks as standard of care

Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]

Given Q12 weeks for bone disease as standard of care

Primary outcome measure

  • Percentage reduction of urine NTX and serum CTX [ Time Frame: 3 months post-treatment ]

Central Contacts and Locations

Central contacts

Locations

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Erin Schenk, MD

Lone Tree Medical Center

Recruiting

Lone Tree, Colorado, United States, 80124

Contacts

Principal Investigator:

Hannah Robinson, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-06-03.