Actively Recruiting

Age: 18Years - 100Years
All Genders
NCT03958565

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

Led by University of Colorado, Denver · Updated on 2025-05-21

100

Participants Needed

2

Research Sites

417 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

C

Cancer League of Colorado

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to sign and date the consent form
  • Willingness to follow all study procedures and be available for the study duration
  • Male or female aged 18 to 100 years
  • Pathologically confirmed non-small cell lung cancer
  • Molecular testing done through a validated NGS assay using tissue or blood samples
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Decision to receive standard of care TKI or chemotherapy with or without immunotherapy before enrollment
  • Dental clearance obtained before starting osteoclast inhibitor treatment
  • Bone metastases detected by radiographic imaging prior to enrollment
Not Eligible

You will not qualify if you...

  • Patients with actionable driver mutation NSCLC who have previously received anti-bone resorptive therapy such as zoledronic acid, pamidronate, alendronate, denosumab, or any osteoclast inhibitor
  • Any condition or illness that may compromise safety or interfere with treatment evaluation
  • Patients with actionable driver mutations who have received or are currently receiving TKI treatment prior to screening
  • Bone metastases previously treated with radiotherapy unless clear progression has occurred since radiation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of Colorado Hospital

Aurora, Colorado, United States, 80045

Actively Recruiting

2

Lone Tree Medical Center

Lone Tree, Colorado, United States, 80124

Actively Recruiting

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Research Team

F

Febin Elias

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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