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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT03958565
Status
Recruiting
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Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Tyrosine Kinase Inhibitor — BIOLOGICAL
    Targeted therapy given as standard of care.
  • Zoledronic Acid 4 MG/100 ML Intravenous Solution [ZOMETA] — DRUG
    Given Q4 weeks as standard of care
  • Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA] — DRUG
    Given Q12 weeks for bone disease as standard of care

Study Details

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.

Key Dates

Start date
Apr 28, 2020
Status verified
Jun 2026
Primary completion
Mar 5, 2028
Completion
Apr 28, 2028

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045
Vincent Johnson
[email protected]
3037249805
Erin Schenk, MD (PRINCIPAL_INVESTIGATOR)
Lone Tree Medical CenterLone TreeColorado80124
Sung-Ae Woo
[email protected]
720-516-9482
Hannah Robinson, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Colorado Hospital· Aurora, COLone Tree Medical Center· Lone Tree, CO

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