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%
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is researching an investigational drug, called BNT116, in combination with cemiplimab. BNT116 and cemiplimab will each be called a "study drug", and together be called "study drugs". The study is focused on patients who have advanced non-small cell lung cancer (NSCLC). The aims of this study are to see how safe and tolerable BNT116 is in combination with cemiplimab and to see how effective BNT116 in combination with cemiplimab is compared to cemiplimab by itself at treating cancer. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drugs * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the drug less effective or could lead to side effects)
Study identification
- NCT ID
- NCT05557591
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 51 participants
Conditions and interventions
Conditions
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 Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05557591 live on ClinicalTrials.gov.