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

Last updated: May 15, 2025
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]

Tyrosine Kinase Inhibitor

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

Clinical Study ID

NCT03958565
19-0392.cc
NCI-2019-03377
  • Ages 18-100
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision to sign and date the consent form

  2. Stated willingness to comply with all study procedures and be available for theduration 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 eithertissue 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 dentalclearance prior to starting treatment

  9. Bone metastases must be detected through radiographic imaging prior to enrollment onthis study.

Exclusion

Exclusion Criteria:

  1. Actionable driver mutation NSCLC patient who has been on anti-bone resorptivetherapy 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, wouldcompromise participant safety or interfere with evaluation while on standard of caretreatments for the NSCLC.

  3. Patients with actionable driver mutation who received TKI in past or currently onTKI prior to screening

  4. Bone metastases that have received prior radiotherapy unless unequivocal progressionhas occurred since radiation therapy

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]
Phase:
Study Start date:
April 28, 2020
Estimated Completion Date:
April 28, 2028

Study Description

This is an observational study involving two arms of NSCLC with metastatic bony disease at the time of enrollment in the study. 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. 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.

Baseline and on-treatment imaging and serum total alkaline phosphatase will be performed per SOC.

Additional non-SOC bone turnover markers including , urine N-telopeptide (NTX) and serum C-terminal telopeptide (CTX), will be checked at baseline and then at 1, 3, 6, and 12 months.

Connect with a study center

  • University of Colorado Hospital

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Lone Tree Medical Center

    Lone Tree, Colorado 80124
    United States

    Active - Recruiting

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