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NCT03924869 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Terminated
- Registry status
- Phase 3
- Development phase
- 448
- Enrollment target
NCT03924869 is a Phase 3 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 448 participants.
The verdict
NCT03924869, a Phase 3 study, was terminated before completion, sponsored by Merck Sharp & Dohme.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 448 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected Stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC). The primary study hypothesis is SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution).
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Placebo
- RADIATION Stereotactic Body Radiotherapy (SBRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 448 participants |
| Start Date | 2019-06-25 |
| Est. Completion | 2025-01-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03924869
The ClinicalTrials.gov registry entry for NCT03924869 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 448 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03924869 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03924869 about?
NCT03924869 is a clinical study titled "Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)". The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected Stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC). The primary study hypothesis is SBRT plus ...
What is the current status of trial NCT03924869?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 448 participants. The study started on 2019-06-25. Estimated completion is 2025-01-20.
What interventions are being tested in trial NCT03924869?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (DRUG), Stereotactic Body Radiotherapy (SBRT) (RADIATION).
Who is sponsoring clinical trial NCT03924869?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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