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NCT03996473 · ClinicalTrials.gov registry record · Phase 1
Study to Test the Safety and How Radium-223 Dichloride an Alpha Particle-emitting Radioactive Agent Works in Combination With Pembrolizumab an Immune Checkpoint Inhibitor in Patients With Stage IV Non-small Cell Lung Cancer With Bone Metastases
A Phase 1 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT03996473 is a Phase 1 study that was terminated before completion, run by Bayer. The registered enrollment target is 8 participants.
The verdict
NCT03996473, a Phase 1 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
The purpose of the study was to determine the safety and test the efficacy of the combination of radium-223 dichloride and pembrolizumab in patients with stage IV non-small cell lung cancer (NSCLC) with bone metastases who either had not received any systemic therapy for their advanced disease or had progressed on prior immunologic checkpoint blockade with antibodies against the programmed cell death protein-(ligand) 1 (PD-1/PD-L1). In this study researchers wanted to measure tumor shrinkage in response to treatment and how long that shrinkage lasted and gathered information on safety. Pembrolizumab is an immunologic checkpoint blocker that promotes an immune response against the tumor. Radium-223 dichloride is an alpha particle-emitting radioactive agent which kills cancer cells.
Interventions
- DRUG Pembrolizumab
- DRUG Radium-223 dichloride (Xofigo, BAY 88-8223)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-03-06 |
| Est. Completion | 2023-01-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03996473
The ClinicalTrials.gov registry entry for NCT03996473 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03996473 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03996473 about?
NCT03996473 is a clinical study titled "Study to Test the Safety and How Radium-223 Dichloride an Alpha Particle-emitting Radioactive Agent Works in Combination With Pembrolizumab an Immune Checkpoint Inhibitor in Patients With Stage IV Non-small Cell Lung Cancer With Bone Metastases". The purpose of the study was to determine the safety and test the efficacy of the combination of radium-223 dichloride and pembrolizumab in patients with stage IV non-small cell lung cancer (NSCLC) with bone metastases who either had not received any systemic therapy for their advanced disease or ha...
What is the current status of trial NCT03996473?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2020-03-06. Estimated completion is 2023-01-30.
What interventions are being tested in trial NCT03996473?
The interventions under investigation include: Pembrolizumab (DRUG), Radium-223 dichloride (Xofigo, BAY 88-8223) (DRUG).
Who is sponsoring clinical trial NCT03996473?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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