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RecruitingNCT03958565

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

◆ AI Clinical Summary

This study looks at how bone metastases (cancer that has spread to bones) respond to targeted drug treatments in patients with non-small cell lung cancer. Researchers will measure specific markers in urine and blood that show bone breakdown to see if these targeted drugs help slow or stop bone damage.

Key Objective:The trial tests whether targeted tyrosine kinase inhibitor drugs can reduce bone damage in lung cancer patients whose tumors have specific genetic mutations.

Who to Consider:Patients with non-small cell lung cancer that has spread to the bones should consider enrolling, especially those whose tumors have actionable genetic driver mutations.

Trial Parameters

ConditionCarcinoma, Non-Small-Cell Lung
SponsorUniversity of Colorado, Denver
Study TypeOBSERVATIONAL
PhaseN/A
Enrollment100
SexALL
Min Age18 Years
Max Age100 Years
Start Date2020-04-28
Completion2028-03-05
Interventions
Tyrosine Kinase InhibitorZoledronic Acid 4 MG/100 ML Intravenous Solution [ZOMETA]Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]

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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.

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, den

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