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 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: R2810-ONC-20452021-006901-312023-503221-19-00
• Study Type: interventional
• Target: 51
• Locations: 7 countries
• Sites: 52

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

Keywords

Cancer Vaccine; Immunotherapy; Programmed cell death ligand-1 (PD-L1) monoclonal antibody; Treatment naïve Advanced Non-Small Cell Lung Cancer (NSCLC); EMPOWERVAX Lung 1

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) as assessed by blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

  Proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR)

  Up to 136 weeks from randomization

Secondary Outcomes (10)

• ORR by investigator assessment

  Up to 136 weeks from randomization

• Duration of Response (DOR) as assessed by BIRC using RECIST 1.1

  Up to 3 years from last patient randomized

• DOR by investigator assessment

  Up to 3 years from last patient randomized

• Progression Free Survival (PFS) as assessed by BIRC using RECIST 1.1

  Up to 3 years from last patient randomized

• PFS by investigator assessment

  Up to 3 years from last patient randomized

Study Arms (2)

Phase 2: Cemiplimab

EXPERIMENTAL

Arm A: Cemiplimab is administered by IV infusion Q3W

Drug: Cemiplimab

Phase 2: BNT116 + Cemiplimab

EXPERIMENTAL

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

Drug: BNT116; Drug: Cemiplimab

Interventions

BNT116 DRUG

BNT116 is administered by IV injection.

Phase 2: BNT116 + Cemiplimab

Cemiplimab DRUG

Cemiplimab is administered Q3W by IV infusion

Also known as: REGN2810, Libtayo

Phase 2: BNT116 + Cemiplimab; Phase 2: Cemiplimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample as defined in the protocol.
• Expression of Programmed cell death ligand-1 (PD-L1) ≥50%, as described in the protocol.
• 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
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1

You may not qualify if:

• Participants who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
• 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
• 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
• Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment
• 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
• Prior splenectomy
• Uncontrolled infection with human immunodeficiency virus (HIV), HBV or hepatitis C infection (HCV); or diagnosis of immunodeficiency as defined in the protocol
• 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)
• Participants requiring corticosteroid therapy (\>5 mg prednisone/day or equivalent) within 14 days of randomization
• 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
• Documented or suspected ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as defined in the protocol
• Patients who have received prior systemic therapies for NSCLC are excluded except for of the following:
• 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.
• 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.
• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• BioNTech SE: collaborator

Study Sites (52)

The Oncology Institute of Hope and Innovation

Los Angeles, California, 90033, United States

Location

UCLA Medical Center

Santa Monica, California, 90095, United States

Location

Norton Cancer Institute, Downtown

Louisville, Kentucky, 40202, United States

Location

San Juan Oncology Associates

Farmington, New Mexico, 87401, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

FirstHealth of the Carolinas Outpatient Cancer Center

Pinehurst, North Carolina, 28374, United States

Location

Millenium Research & Clinical Development

Houston, Texas, 77090, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

LTD High Technology Hospital Medcenter

Batumi, 6000, Georgia

Location

LLC Todua Clinic

Tbilisi, 0112, Georgia

Location

LTD New Hospitals

Tbilisi, 0114, Georgia

Location

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

Tbilisi, 0144, Georgia

Location

LTD Cancer Research Centre

Tbilisi, 0179, Georgia

Location

Caucasus Medical Centre

Tbilisi, 0186, Georgia

Location

Staedtisches Klinikum Muenchen Bogenhausen

München, Bavaria, 81925, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt

Frankfurt, 60590, Germany

Location

Universitaetsklinikum Giessen Und Marburg Gmbh Standort Giessen

Giessen, 80336, Germany

Location

Krankenhaus Martha-Maria Halle-Doelau gGmbH

Halle, 06120, Germany

Location

Klinikverbund Kempten-Oberallgäu

Kempten, 87349, Germany

Location

Korea University Anam Hospital

Seoul, Gyeonggi-do, 02841, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

Location

National Cancer Center Korea

Goyang, 10408, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Yonsei Severance

Seoul, 3722, South Korea

Location

Samsung Medical Center

Seoul, 6351, South Korea

Location

Seoul National University Hospital

Seoul, 744, South Korea

Location

Catalan Institute of Oncology Badalona

Badalona, Barcelona, 08916, Spain

Location

Althaia Xarxa Assistencial Universitaria Manresa

Manresa, Barcelona, 08243, Spain

Location

Consorcio Hospitalario Provincial de Castellon

Castellon, Castellon, 12002, Spain

Location

Hospital General Universitario Gregorio Marañon (HGUGM)

Madrid, 28007, Spain

Location

Clinica Universidad de Navarra - Madrid

Madrid, 28027, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

Location

Hospital Universitario Virgen del Rocio

Málaga, 29010, Spain

Location

Clinica Universidad de Navarra

Pamplona, 31008, Spain

Location

Instituto Valenciano de Oncologia

Valencia, 46009, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Kaohsiung Medical University - Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Taipei Tzu Chi Hospital

New Taipei City, 23142, Taiwan

Location

Taipei Medical University - Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

National Taiwan University Hospital

Taipei, 100225, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Adana Medical Park Seyhan Hospital

Adana, Adana, 01140, Turkey (Türkiye)

Location

Baskent University

Yüreğir, Adana, 01230, Turkey (Türkiye)

Location

Yeditepe University Kosuyolu Hospital

Kadıköy, Istanbul, 34718, Turkey (Türkiye)

Location

Ege University Faculty of Medicine

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Ozel Liv Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam

Ankara, 06100, Turkey (Türkiye)

Location

Bezmialem Foundation University Medical Faculty

Istanbul, 34093, Turkey (Türkiye)

Location

Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital

Istanbul, 81450, Turkey (Türkiye)

Location

Izmir Economy University Medical Point Hospital

Izmir, 35325, Turkey (Türkiye)

Location

MeSH Terms

Interventions

cemiplimab

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 28, 2022
• Study Start: April 21, 2023
• Primary Completion (Estimated): January 26, 2028
• Study Completion (Estimated): May 16, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

DE (5); TU (9); TW (5); US (9); GE (6); KR (7); ES (11)