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)
Public ClinicalTrials.gov record NCT03924869. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03924869
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 448 participants
Conditions and interventions
Conditions
Interventions
- Stereotactic Body Radiotherapy (SBRT) Radiation
- Pembrolizumab Biological
- Placebo Drug
Radiation · Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 25, 2019 (Actual)
- Primary completion
- Jun 11, 2024 (Actual)
- Completion
- Jan 20, 2025 (Actual)
- Last update posted
- Dec 11, 2025
2019 – 2025
United States locations
- U.S. sites
- 42
- U.S. states
- 22
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama ( Site 0099) | Birmingham | Alabama | 35233 | — |
| Infirmary Cancer Care ( Site 3044) | Mobile | Alabama | 36607 | — |
| Alaska Oncology and Hematology ( Site 3063) | Anchorage | Alaska | 99508 | — |
| Banner MD Anderson Cancer Center ( Site 3029) | Gilbert | Arizona | 85234 | — |
| CARTI Cancer Center ( Site 3045) | Little Rock | Arkansas | 72205 | — |
| USC Norris Comprehensive Cancer Center ( Site 0007) | Los Angeles | California | 90033 | — |
| Veterans Affairs Palo Alto Health Care System ( Site 3039) | Palo Alto | California | 94304 | — |
| National Jewish Health ( Site 0010) | Denver | Colorado | 80206 | — |
| Yale University ( Site 0011) | New Haven | Connecticut | 06510 | — |
| Mid Florida Hematology and Oncology Center ( Site 0067) | Orange City | Florida | 32763 | — |
| H. Lee Moffitt Cancer Center and Research Institute ( Site 0016) | Tampa | Florida | 33612 | — |
| Goshen Center for Cancer Care ( Site 0022) | Goshen | Indiana | 46526 | — |
| Franciscan Health Indianapolis ( Site 0024) | Indianapolis | Indiana | 46237 | — |
| University of Kentucky School of Medicine & Hospitals ( Site 0026) | Lexington | Kentucky | 40536 | — |
| Sinai Hospital of Baltimore ( Site 3011) | Baltimore | Maryland | 21215 | — |
| William E. Kahlert Regional Cancer Center ( Site 3031) | Westminster | Maryland | 21157 | — |
| Massachusetts General Hospital-Cancer Center Protocol Office ( Site 3007) | Boston | Massachusetts | 02114 | — |
| Mass General / North Shore Center for Outpatient Care ( Site 3040) | Danvers | Massachusetts | 01923 | — |
| University of Massachusetts ( Site 0029) | Worcester | Massachusetts | 01655 | — |
| Sanford Bemidji ( Site 0080) | Bemidji | Minnesota | 56601 | — |
| University of Minnesota ( Site 0069) | Minneapolis | Minnesota | 55455 | — |
| University of Missouri Hospital ( Site 3058) | Columbia | Missouri | 65212 | — |
| Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 3060) | Springfield | Missouri | 65807 | — |
| St. Vincent Healthcare Frontier Cancer Center ( Site 3012) | Billings | Montana | 59102 | — |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 3036) | Hackensack | New Jersey | 07601 | — |
| Rutgers Cancer Institute of New Jersey ( Site 0043) | New Brunswick | New Jersey | 08903-2681 | — |
| Hematology-Oncology Associates of CNY ( Site 3055) | East Syracuse | New York | 13057 | — |
| Mount Sinai Hospital ( Site 0046) | New York | New York | 10029 | — |
| Westchester Medical Center ( Site 3057) | Valhalla | New York | 10595 | — |
| White Plains Hospital ( Site 3014) | White Plains | New York | 10601 | — |
| Sanford Health Roger Maris Cancer Center ( Site 0079) | Fargo | North Dakota | 58102 | — |
| Lehigh Valley Hospital- Cedar Crest ( Site 3005) | Allentown | Pennsylvania | 18103 | — |
| St. Luke's University Health Network ( Site 3006) | Bethlehem | Pennsylvania | 18015 | — |
| Penn State University Milton S. Hershey Medical Center ( Site 0064) | Hershey | Pennsylvania | 17033 | — |
| Fox Chase Cancer Center ( Site 0051) | Philadelphia | Pennsylvania | 19111 | — |
| Allegheny General Hospital ( Site 3028) | Pittsburgh | Pennsylvania | 15212 | — |
| Lankenau Medical Center ( Site 3041) | Wynnewood | Pennsylvania | 19096 | — |
| Sanford Cancer Center Oncology Clinic ( Site 0053) | Sioux Falls | South Dakota | 57104 | — |
| Mountain States Health Alliance ( Site 3054) | Johnson City | Tennessee | 37604 | — |
| University of Tennessee Medical Center Knoxville ( Site 3010) | Knoxville | Tennessee | 37920 | — |
| Vanderbilt University Medical Center ( Site 0075) | Nashville | Tennessee | 37232 | — |
| Cancer Care Northwest ( Site 0063) | Spokane Valley | Washington | 99216 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 152 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03924869, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 11, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03924869 live on ClinicalTrials.gov.