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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: Clinical Trial Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03924869 is a Phase 3 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 448 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
EFS was defined as the time from randomization to the first occurrence of any of the following events: 1) local, regional, or distant recurrence of disease as assessed by radiographic recurrence by blinded independent central review (BICR), positive pathology by local assessment, physical examination by local assessment confirmed by positive pathology and/or radiographic recurrence by BICR, OR 2) death due to any cause. EFS was reported for each arm.
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 |
Why NCT03924869 stopped before completion
NCT03924869 is an interventional study that assigns participants to a tested intervention. The registered 448 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03924869 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03924869's enrollment target sits among peer trials
448 864th of 2000 higher than 1,137 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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