NCT03958565|Recruiting
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Sponsor study identifier
Secondary identifiers
OTHER · CTRP
observational
100
1 country
2
Study Start
April 28, 2020
Actual (reported)Primary Completion
March 5, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 14, 2019
Actual (reported)May 22, 2019
Actual (reported)April 28, 2020
Actual (reported)March 5, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
Targeted therapy given as standard of care.
Given Q4 weeks as standard of care
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.
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Lone Tree Medical Center
Lone Tree, Colorado, 80124, United States
Erin Schenk, MD
University of Colorado, Denver
First Submitted
May 14, 2019
First Posted
May 22, 2019
Study Start
April 28, 2020
Actual (reported)Primary Completion
March 5, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC)
Given Q12 weeks for bone disease as standard of care
Contact the study team to confirm eligibility.
Study Completion
April 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 3, 2026
Record last verified: 2026-06
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.
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Source: ClinicalTrials.gov.
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