Assessing the impact of Tyrosine Kinase Inhibitors on bone metastasis in lung cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the response of patients with non-small cell lung cancer (NSCLC) and bone metastases to standard treatments. It involves two groups: one with actionable driver mutations receiving Tyrosine Kinase Inhibitors (TKIs) and the other without such mutations receiving chemotherapy or immunotherapy alongside bone resorption inhibitors. The study measures changes in bone turnover markers and imaging results over a 12-month period to assess treatment efficacy. Participants will undergo regular monitoring of their condition and treatment response.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

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

   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, 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

Where it's running

• University of Colorado Hospital
  Aurora, Colorado, United States Recruiting
• Lone Tree Medical Center
  Lone Tree, Colorado, United States Recruiting

Study contacts

• Principal investigator: Erin Schenk, MD — University of Colorado, Denver
• Study coordinator: Febin Elias
• Email: febin.elias@cuanschutz.edu
• Phone: 13037249459

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.