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)

NCT ID: NCT05557591

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-21
• Study Completion Date: 2028-05-16

Brief Summary

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)

Conditions

Advanced Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 2: Cemiplimab

Arm A: Cemiplimab is administered by IV infusion Q3W

Group Type: EXPERIMENTAL

Cemiplimab

Intervention Type: DRUG

Cemiplimab is administered Q3W by IV infusion

Phase 2: BNT116 + Cemiplimab

Arm B: BNT116 is administered by IV injection. Cemiplimab is administered by IV infusion Q3W.

Group Type: EXPERIMENTAL

BNT116

Intervention Type: DRUG

BNT116 is administered by IV injection.

Cemiplimab

Intervention Type: DRUG

Cemiplimab is administered Q3W by IV infusion

Interventions

BNT116

BNT116 is administered by IV injection.

Intervention Type: DRUG

Cemiplimab

Cemiplimab is administered Q3W by IV infusion

Intervention Type: DRUG

Other Intervention Names

REGN2810; Libtayo

Eligibility Criteria

Inclusion Criteria

1. Participants with non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC disease who are not candidates for surgical resection or definitive chemoradiation per investigator assessment or stage IV (metastatic) disease who received no prior systemic treatment for recurrent or metastatic NSCLC

2. Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample as defined in the protocol.

3. Expression of Programmed cell death ligand-1 (PD-L1) ≥50%, as described in the protocol.

4. Participants must have at least 1 radiographically measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria

5. Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Exclusion Criteria

1. Participants who have never smoked, defined as smoking ≤100 cigarettes in a lifetime

2. Active or untreated brain metastases or spinal cord compression. Participants are eligible if central nervous system (CNS) metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment

3. Participants with tumors tested positive for epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene receptor tyrosine kinase 1 (ROS1) fusions

4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment

5. Participants with history of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years

6. Prior splenectomy

7. Uncontrolled infection with human immunodeficiency virus (HIV), HBV or hepatitis C infection (HCV); or diagnosis of immunodeficiency as defined in the protocol

8. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk of immune-related treatment-emergent adverse events (imTEAEs)

9. Participants requiring corticosteroid therapy (>5 mg prednisone/day or equivalent) within 14 days of randomization

10. Another malignancy that is progressing or requires treatment, except for non melanomatous skin cancer that has undergone potentially curative therapy, in situ cervical carcinoma, or any other localized tumor that has been treated, and the participant is deemed to be in complete remission for at least 2 years prior to enrollment, and no additional therapy is required during the study period

11. Documented or suspected ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as defined in the protocol

12. Patients who have received prior systemic therapies for NSCLC are excluded except for of the following:

1. Adjuvant or neoadjuvant platinum-based doublet chemotherapy (after surgery and/or radiation therapy) if recurrent or metastatic disease develops more than 6 months after completing therapy if toxicities have resolved to CTCAE grade ≤1 or baseline except for alopecia and peripheral neuropathy.

2. Anti-PD-(L)1 with or without LAG-3 as an adjuvant or neoadjuvant therapy as long as the last dose is >12 months prior to enrollment.

3. Prior exposure to other immunomodulatory or vaccine therapies as an adjuvant or neoadjuvant therapy such as anti-cytotoxic T lymphocyte-associated antigen (anti-CTLA-4) antibodies if the last dose is >6 months prior to enrollment

13. History or current evidence of significant cardiovascular disease including, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classification III and IV), unstable angina, serious uncontrolled arrhythmia, and myocardial infarction 6 months prior to study enrollment.

14. Hypersensitivity to cemiplimab or BNT116 or any of their excipients, or contraindicated to cemiplimab per approved local labeling.

15. Patients treated with immunostimulatory agents that may influence the efficacy of the investigational medicinal products (IMPs) are not allowed if they received such agents within 6 weeks or five halve lives of the drug.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioNTech SE

INDUSTRY

Sponsor Role: collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

The Oncology Institute of Hope and Innovation

Los Angeles, California, United States

UCLA Medical Center

Santa Monica, California, United States

Norton Cancer Institute, Downtown

Louisville, Kentucky, United States

San Juan Oncology Associates

Farmington, New Mexico, United States

Weill Cornell Medicine

New York, New York, United States

FirstHealth of the Carolinas Outpatient Cancer Center

Pinehurst, North Carolina, United States

Millenium Research & Clinical Development

Houston, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Northwest Medical Specialties, PLLC

Tacoma, Washington, United States

LTD High Technology Hospital Medcenter

Batumi, , Georgia

LLC Todua Clinic

Tbilisi, , Georgia

LTD New Hospitals

Tbilisi, , Georgia

LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

Tbilisi, , Georgia

LTD Cancer Research Centre

Tbilisi, , Georgia

Caucasus Medical Centre

Tbilisi, , Georgia

Staedtisches Klinikum Muenchen Bogenhausen

München, Bavaria, Germany

Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt

Frankfurt, , Germany

Universitaetsklinikum Giessen Und Marburg Gmbh Standort Giessen

Giessen, , Germany

Krankenhaus Martha-Maria Halle-Doelau gGmbH

Halle, , Germany

Klinikverbund Kempten-Oberallgäu

Kempten, , Germany

Korea University Anam Hospital

Seoul, Gyeonggi-do, South Korea

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

National Cancer Center Korea

Goyang, , South Korea

Asan Medical Center

Seoul, , South Korea

Yonsei Severance

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Catalan Institute of Oncology Badalona

Badalona, Barcelona, Spain

Althaia Xarxa Assistencial Universitaria Manresa

Manresa, Barcelona, Spain

Consorcio Hospitalario Provincial de Castellon

Castellon, Castellon, Spain

Hospital General Universitario Gregorio Marañon (HGUGM)

Madrid, , Spain

Clinica Universidad de Navarra - Madrid

Madrid, , Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Hospital Regional Universitario de Malaga

Málaga, , Spain

Hospital Universitario Virgen del Rocio

Málaga, , Spain

Clinica Universidad de Navarra

Pamplona, , Spain

Instituto Valenciano de Oncologia

Valencia, , Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, , Spain

Kaohsiung Medical University - Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Taipei Tzu Chi Hospital

New Taipei City, , Taiwan

Taipei Medical University - Shuang Ho Hospital

New Taipei City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Adana Medical Park Seyhan Hospital

Adana, Adana, Turkey (Türkiye)

Baskent University

Yüreğir, Adana, Turkey (Türkiye)

Yeditepe University Kosuyolu Hospital

Kadıköy, Istanbul, Turkey (Türkiye)

Ege University Faculty of Medicine

Bornova, İzmir, Turkey (Türkiye)

Ozel Liv Hospital

Ankara, , Turkey (Türkiye)

Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam

Ankara, , Turkey (Türkiye)

Bezmialem Foundation University Medical Faculty

Istanbul, , Turkey (Türkiye)

Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital

Istanbul, , Turkey (Türkiye)

Izmir Economy University Medical Point Hospital

Izmir, , Turkey (Türkiye)

Countries

United States; Georgia; Germany; South Korea; Spain; Taiwan; Turkey (Türkiye)

Other Identifiers

2021-006901-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-503221-19-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

R2810-ONC-2045

Identifier Type: -

Identifier Source: org_study_id