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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Targeted therapy given as standard of care.
Given Q4 weeks as standard of care
Given Q12 weeks for bone disease as standard of care
University of Colorado Hospital
Aurora, Colorado, United States
RECRUITINGLone Tree Medical Center
Lone Tree, Colorado, United States
RECRUITINGPercentage reduction of urine NTX and serum CTX
The percentage reduction in the bone turnover markers including urine N-telopeptide (NTX) and serum C-terminal telopeptide (CTX) from baseline at 3 months from starting TKI (oncogene arm) or anti-resorptive therapy as part of standard systemic therapy (non-oncogene arm).
Time frame: 3 months post-treatment
Skeletal-related events (SREs)
Skeletal-related events (SREs) defined as the adverse events associated with bone metastases. SREs would include pathologic fractures, the requirement for surgery or radiotherapy, spinal cord compression.
Time frame: 1, 3, 6, and 12 months post-treatment
Progression Free Survival (PFS)
Progression Free Survival (PFS) would be defined as progression of disease or death from any cause from time of randomization until the end of study.
Time frame: at 1 year
Objective Response Rate (ORR)
Objective Response Rate (ORR) defined as proportion of patients with reduction in bony metastases as evaluated by using both the MD Anderson (MDA) criteria for patients who receive CT or bone scans and Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) for patients who undergo FDG PET/CT. These criteria allow for categorization of disease response from complete response to progressive disease.
Time frame: at 1 year
Percentage reduction in the bone turnover markers including urine N-telopeptide (NTX) and serum C-terminal telopeptide (CTX)
Percentage reduction in the bone turnover markers including urine N-telopeptide (NTX) and serum C-terminal telopeptide (CTX) from baseline at 1, 6 and 12 months.
Time frame: From Baseline at 1, 6, and 12 months post-treatment
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Percentage normalization of blood total alkaline phosphatase
Percentage normalization of blood total alkaline phosphatase from baseline at 1, 3, 6, and 12 months. Normal level of blood total alkaline phosphatase would be defined as equal or less than 147 IU/L.
Time frame: From baseline at 1, 3, 6, and 12 months