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NCT03958565 · ClinicalTrials.gov registry record
Response of Bony Metastasis to Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancers With Actionable Driver Mutations.
A clinical trial of Carcinoma, Non-Small Cell Lung, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- 100
- Enrollment target
- 2
- Study locations
NCT03958565: Recruiting study of Carcinoma, Non-Small Cell Lung, sponsored by University of Colorado, Denver.
NCT03958565 is a study of Carcinoma, Non-Small Cell Lung that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 100 participants, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (69% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03958565, a study of Carcinoma, Non-Small Cell Lung, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- BIOLOGICAL Tyrosine Kinase Inhibitor
- DRUG Zoledronic Acid 4 MG/100 ML Intravenous Solution [ZOMETA]
- DRUG Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]
Study Locations (2)
Colorado
- University of Colorado Hospital - Aurora
- Lone Tree Medical Center - Lone Tree
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-04-28 |
| Est. Completion | 2028-04-28 |
What NCT03958565 shows while recruiting
NCT03958565 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 3 interventions - of which Tyrosine Kinase Inhibitor is the first listed.
NCT03958565 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT03958565 about?
NCT03958565 is a clinical study titled "Response of Bony Metastasis to Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancers With Actionable Driver Mutations.". 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 (chem...
What is the current status of trial NCT03958565?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2020-04-28. Estimated completion is 2028-04-28.
What conditions does trial NCT03958565 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT03958565?
The interventions under investigation include: Tyrosine Kinase Inhibitor (BIOLOGICAL), Zoledronic Acid 4 MG/100 ML Intravenous Solution [ZOMETA] (DRUG), Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA] (DRUG).
Who is sponsoring clinical trial NCT03958565?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03958565 being conducted?
This trial has 2 study locations across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03958565's enrollment target sits among peer trials
100 72nd of 130 higher than 58 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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