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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how treatment changes urine and blood markers of bone breakdown after 3 months in people with non-small cell lung cancer that has spread to bone. It studies people with gene changes that can be targeted by drugs called TKIs, and people without these changes who get chemotherapy or immune therapy plus zoledronic acid or denosumab.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 100 years old.
  • Have non-small cell lung cancer confirmed by lab testing.
  • Have cancer that has spread to bone, shown on imaging scans before joining.
  • Have gene testing using a tissue or blood sample through a lab test that meets required standards.
  • Be able to care for yourself and be out of bed or a chair for more than half of your waking hours (ECOG score 0–2).
  • Have a treatment plan chosen before joining: a TKI drug or chemotherapy with or without immune therapy.
  • Get a dentist’s approval before starting a drug that slows bone breakdown, if this treatment is planned.
  • Sign and date the consent form, agree to follow study steps, and be available for the whole study.

Who can't join

  • If your cancer has a gene change that can be targeted: have used drugs that slow bone breakdown, such as zoledronic acid, pamidronate, alendronate, or denosumab.
  • Have a health problem that the study doctor believes could make treatment unsafe or make study results hard to assess.
  • If your cancer has a gene change that can be targeted: have taken a TKI drug before screening or are taking one now.
  • Have had radiation to cancer in the bones, unless that cancer has clearly gotten worse since radiation.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (2)

CO