Lung Cancer Clinical Trial
Response of Bony Metastasis to Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancers With Actionable Driver Mutations.
Summary
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.
Full Description
This is an observational study involving two arms of NSCLC with metastatic bony disease at the time of enrollment in the study. One group will have an actionable driver oncogene and initiate treatment in any line with a TKI as standard of care and concurrent to participation to this study; expected to have an objective response rate in ≥40% who have not previously seen anti-bone resorptive therapy. The other group will not have actionable mutations and initiate treatment with chemotherapy/immunotherapy along with new onset therapy with IV zoledronic acid 4mg Q4 weeks or subcutaneous denosumab 120 mg Q12 weeks for bone disease, which is standard of care and would be concurrent to participation in this study.
Baseline and on-treatment imaging and serum total alkaline phosphatase will be performed per SOC.
Additional non-SOC bone turnover markers including , urine N-telopeptide (NTX) and serum C-terminal telopeptide (CTX), will be checked at baseline and then at 1, 3, 6, and 12 months.
Eligibility Criteria
Inclusion Criteria:
Provision to sign and date the consent form
Stated willingness to comply with all study procedures and be available for the duration of the study
Be a male or female aged 18-100 years
Pathologically confirmed Non-Small Cell Lung Cancer with bone metastasis and with or without driver actionable oncogene
ECOG PS 0-2
Decision to be on a particular standard of care TKI or chemotherapy/immunotherapy (clinical decision that would occur prior to study enrollment)
Exclusion Criteria:
Actionable driver mutation NSCLC patient who has been on anti-bone resorptive therapy
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
Patients with actionable driver mutation who received TKI in past or currently on TKI prior to screening
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There is 1 Location for this study
Aurora Colorado, 80045, United States More Info
Principal Investigator
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