A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)
Public ClinicalTrials.gov record NCT05557591. 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 2 Study of Cemiplimab (Anti-PD-1 Antibody) in Combination With BNT116 (FixVac Lung) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50%
Study identification
- NCT ID
- NCT05557591
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Regeneron Pharmaceuticals
- Industry
- Enrollment
- 51 participants
Conditions and interventions
Conditions
Interventions
- BNT116 Drug
- Cemiplimab Drug
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
- Apr 20, 2023
- Primary completion
- Jan 25, 2028
- Completion
- May 15, 2028
- Last update posted
- May 5, 2026
2023 – 2028
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Oncology Institute of Hope and Innovation | Los Angeles | California | 90033 | — |
| UCLA Medical Center | Santa Monica | California | 90095 | — |
| Norton Cancer Institute, Downtown | Louisville | Kentucky | 40202 | — |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | — |
| Weill Cornell Medicine | New York | New York | 10065 | — |
| FirstHealth of the Carolinas Outpatient Cancer Center | Pinehurst | North Carolina | 28374 | — |
| Millenium Research & Clinical Development | Houston | Texas | 77090 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | — |
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 43 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05557591, 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 May 5, 2026 · Synced May 8, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05557591 live on ClinicalTrials.gov.