Actively Recruiting
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
Eligibility Criteria
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
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
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
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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