Response of Bony Metastasis to Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancers With Actionable Driver Mutations.
2 other identifiers
observational
100
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2019
CompletedFirst Posted
Study publicly available on registry
May 22, 2019
CompletedStudy Start
First participant enrolled
April 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 28, 2028
May 21, 2025
May 1, 2025
7.9 years
May 14, 2019
May 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage 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).
3 months post-treatment
Secondary Outcomes (5)
Skeletal-related events (SREs)
1, 3, 6, and 12 months post-treatment
Progression Free Survival (PFS)
at 1 year
Objective Response Rate (ORR)
at 1 year
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
Percentage normalization of blood total alkaline phosphatase
From baseline at 1, 3, 6, and 12 months
Study Arms (2)
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.
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.
Interventions
Targeted therapy given as standard of care.
Given Q4 weeks as standard of care
Given Q12 weeks for bone disease as standard of care
Eligibility Criteria
About 30-40% of patients w/ lung cancer develop bone metastases during their disease; the median survival time of patients w/ this secondary lesion is 7 months. In a retrospective study of 259 non-small cell lung cancer (NSCLC) patients, the most common site of skeletal metastases was the spine in 50% of patients, followed by the ribs (27.1%), ilium (10%), sacrum (7.1%), femur (5.7%) \&humerus, scapula \& sternum (2.9%). At our institution, it is standard practice not to use anti-bone resorptive therapy in driver mutation-addicted NSCLC w/ bony metastasis, while anti-bone resorptive therapies are commonly used in NSCLC w/ bony metastases w/o any actionable driver mutation. This study relates to exploring the potential differential need for anti-resorptive bone medications (bisphosphonates or RANK-L inhibitors) in patients w/ advanced non-small cell lung cancer \& bone metastases w/ \& w/o actionable driver mutations.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- Cancer League of Coloradocollaborator
Study Sites (2)
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Lone Tree Medical Center
Lone Tree, Colorado, 80124, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erin Schenk, MD
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2019
First Posted
May 22, 2019
Study Start
April 28, 2020
Primary Completion (Estimated)
March 5, 2028
Study Completion (Estimated)
April 28, 2028
Last Updated
May 21, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- immediately following publication. no end date.
- Access Criteria
- Anyone who wishes to access the data. any purpose. Data are available indefinitely.
Clinical data (including AEs, concomitant medications, and expected adverse reactions data) and clinical laboratory data will be entered into REDCap; the data system includes password protection and internal quality checks, such as automatic range checks, to identify data that appear inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the source documents.Data will be tracked using REDCap. Data collected for this study will be analyzed and stored at the University of Colorado Cancer Center. When the study is completed, access to study data will be provided through the UCCC Oncology Clinical Research Support Team.