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

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

This study is testing if a new type of cancer drug called Tyrosine Kinase Inhibitors can help lung cancer patients with bone metastases feel better compared to those getting standard treatments.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: University of Colorado, Denver (Academic / other)
• Drugs / interventions: denosumab, chemotherapy, immunotherapy, radiation
• Locations: 2 sites (Aurora, Colorado and 1 other locations)
• Trial ID: NCT03958565 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-100 with pathologically confirmed NSCLC and detectable bone metastases, who are either eligible for TKI therapy or standard chemotherapy/immunotherapy.

Not a fit: Patients who have previously received anti-bone resorptive therapy or those without actionable driver mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into more effective treatment strategies for lung cancer patients with bone metastases.

How similar studies have performed: While there have been studies on the effects of TKIs and bone resorption therapies, this specific approach in NSCLC with actionable mutations is relatively novel.

Eligibility criteria

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 this trial is running

Aurora, Colorado and 1 other locations

• 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

Conditions Carcinoma, Non-Small-Cell Lung