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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Hospital, Aurora, Colorado, United States, 80045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 1. Actionable driver mutation NSCLC patient who has been on anti-bone resorptive therapy
  • 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

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Colorado, Denver,

Tejas Patil, MD, PRINCIPAL_INVESTIGATOR, Colorado Research Center

Study Record Dates

2026-03-05