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) (NCT05557591)
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%
🩺 Plain-English Summary (8th-Grade Level)
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)
Who can join: Review the eligibility criteria below.
Location: The Oncology Institute of Hope and Innovation — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (52 Sites)
Showing the first 25 of 52 sites.
- The Oncology Institute of Hope and Innovation — Los Angeles, California
- UCLA Medical Center — Santa Monica, California
- Norton Cancer Institute, Downtown — Louisville, Kentucky
- San Juan Oncology Associates — Farmington, New Mexico
- Weill Cornell Medicine — New York, New York
- FirstHealth of the Carolinas Outpatient Cancer Center — Pinehurst, North Carolina
- Millenium Research & Clinical Development — Houston, Texas
- Virginia Cancer Specialists — Fairfax, Virginia
- Northwest Medical Specialties, PLLC — Tacoma, Washington
- LTD High Technology Hospital Medcenter — Batumi,
- LLC Todua Clinic — Tbilisi,
- LTD New Hospitals — Tbilisi,
- LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic — Tbilisi,
- LTD Cancer Research Centre — Tbilisi,
- Caucasus Medical Centre — Tbilisi,
- Staedtisches Klinikum Muenchen Bogenhausen — München, Bavaria
- Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt — Frankfurt,
- Universitaetsklinikum Giessen Und Marburg Gmbh Standort Giessen — Giessen,
- Krankenhaus Martha-Maria Halle-Doelau gGmbH — Halle,
- Klinikverbund Kempten-Oberallgäu — Kempten,
- Korea University Anam Hospital — Seoul, Gyeonggi-do
- Chonnam National University Hwasun Hospital — Hwasun, Jeollanam-do
- National Cancer Center Korea — Goyang,
- Asan Medical Center — Seoul,
- Yonsei Severance — Seoul,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Advanced Non-Small Cell Lung Cancer
- Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer — Bullhead City, Arizona
- Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Patients — Tarrytown, New York
- A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) — Tucson, Arizona
- T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer — Bethesda, Maryland
- The Study of NC318 Alone or in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer — New Haven, Connecticut
Explore by condition: All Advanced Non-Small Cell Lung Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.