Response of Bony Metastasis to Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancers With Actionable Driver Mutations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Percentage reduction of urine NTX and serum CTX
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Molecular testing through a CLIA-validated NGS assay. This can be done using either tissue based samples or blood-based samples (ctDNA)
- •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)
- •Patients who will be treated with an osteoclast inhibitor must receive dental clearance prior to starting treatment
- •Bone metastases must be detected through radiographic imaging prior to enrollment on this study.
排除标准
- •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
- •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
- •Bone metastases that have received prior radiotherapy unless unequivocal progression has occurred since radiation therapy
研究组 & 干预措施
Actionable driver oncogene
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.
干预措施: Tyrosine Kinase Inhibitor (Biological)
No Actionable Mutations
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.
干预措施: Zoledronic Acid 4 MG/100 ML Intravenous Solution [ZOMETA] (Drug)
No Actionable Mutations
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.
干预措施: Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA] (Drug)
结局指标
主要结局
Percentage reduction of urine NTX and serum CTX
时间窗: 3 months post-treatment
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).
次要结局
- Skeletal-related events (SREs)(1, 3, 6, and 12 months post-treatment)
- 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 post-treatment)
- Objective Response Rate (ORR)(at 1 year)
- Progression Free Survival (PFS)(at 1 year)
- Percentage normalization of blood total alkaline phosphatase(From baseline at 1, 3, 6, and 12 months)