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Advanced Non-Small Cell Lung CancerPhase 2NCT05557591

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)

A Phase 2 study testing BNT116 and Cemiplimab in people with Advanced Non-Small Cell Lung Cancer, run by Regeneron Pharmaceuticals at 52 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Non-Small Cell Lung Cancer
What is being tested?
BNT116 and Cemiplimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
52 sitesin 7 countries
Study dates
21 Apr 2023to 16 May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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
  • 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.
  • Hypersensitivity to cemiplimab or BNT116 or any of their excipients, or contraindicated to cemiplimab per approved local labeling.
  • 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.
  • Note: Other protocol-defined Inclusion/Exclusion criteria apply

Trial locations and contacts

52 sites in 7 countries.

52 sites in 7 countries

Spain11 sites

  • Catalan Institute of Oncology Badalona

    Badalona, Barcelona, 08916

  • Consorcio Hospitalario Provincial de Castellon

    Castellon, Castellon, 12002

  • Hospital General Universitario Gregorio Marañon (HGUGM)

    Madrid, 28007

  • Clinica Universidad de Navarra - Madrid

    Madrid, 28027

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

  • Hospital Universitario Virgen del Rocio

    Málaga, 29010

  • Althaia Xarxa Assistencial Universitaria Manresa

    Manresa, Barcelona, 08243

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Instituto Valenciano de Oncologia

    Valencia, 46009

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

United States9 sites

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • Millenium Research & Clinical Development

    Houston, Texas, 77090

  • The Oncology Institute of Hope and Innovation

    Los Angeles, California, 90033

  • Norton Cancer Institute, Downtown

    Louisville, Kentucky, 40202

  • Weill Cornell Medicine

    New York, New York, 10065

  • FirstHealth of the Carolinas Outpatient Cancer Center

    Pinehurst, North Carolina, 28374

  • UCLA Medical Center

    Santa Monica, California, 90095

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

Other trials in United States

Turkey (Türkiye)9 sites

  • Adana Medical Park Seyhan Hospital

    Adana, Adana, 01140

  • Ozel Liv Hospital

    Ankara, 06100

  • Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam

    Ankara, 06100

  • Ege University Faculty of Medicine

    Bornova, İzmir, 35100

  • Bezmialem Foundation University Medical Faculty

    Istanbul, 34093

  • Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital

    Istanbul, 81450

  • Izmir Economy University Medical Point Hospital

    Izmir, 35325

  • Yeditepe University Kosuyolu Hospital

    Kadıköy, Istanbul, 34718

  • Baskent University

    Yüreğir, Adana, 01230

Other trials in Turkey (Türkiye)

South Korea7 sites

  • National Cancer Center Korea

    Goyang, 10408

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128

  • Korea University Anam Hospital

    Seoul, Gyeonggi-do, 02841

  • Asan Medical Center

    Seoul, 05505

  • Yonsei Severance

    Seoul, 3722

  • Samsung Medical Center

    Seoul, 6351

  • Seoul National University Hospital

    Seoul, 744

Other trials in South Korea

Georgia6 sites

  • LTD High Technology Hospital Medcenter

    Batumi, 6000

  • LLC Todua Clinic

    Tbilisi, 0112

  • LTD New Hospitals

    Tbilisi, 0114

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

    Tbilisi, 0144

  • LTD Cancer Research Centre

    Tbilisi, 0179

  • Caucasus Medical Centre

    Tbilisi, 0186

Other trials in Georgia

Germany5 sites

  • Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt

    Frankfurt, 60590

  • Universitaetsklinikum Giessen Und Marburg Gmbh Standort Giessen

    Giessen, 80336

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    Halle, 06120

  • Klinikverbund Kempten-Oberallgäu

    Kempten, 87349

  • Staedtisches Klinikum Muenchen Bogenhausen

    München, Bavaria, 81925

Other trials in Germany

Taiwan5 sites

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Taipei Tzu Chi Hospital

    New Taipei City, 23142

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City, 23561

  • National Taiwan University Hospital

    Taipei, 100225

  • Tri-Service General Hospital

    Taipei, 114

Other trials in Taiwan

About this study

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%

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.

Read more

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)
Being tested
BNT116, Cemiplimab
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BNT116Drug

    BNT116 is administered by IV injection.

  • CemiplimabDrug

    Also called REGN2810, Libtayo

    Cemiplimab is administered Q3W by IV infusion

Study groups in NCT05557591
Study groupRoleWhat they receive
Phase 2: CemiplimabExperimentalArm A: Cemiplimab is administered by IV infusion Q3W
Receives: Drug: Cemiplimab
Phase 2: BNT116 + CemiplimabExperimentalArm B: BNT116 is administered by IV injection. Cemiplimab is administered by IV infusion Q3W.
Receives: Drug: BNT116; Drug: Cemiplimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Up to 136 weeks from randomization

Secondary outcomes (10)

  1. ORR by investigator assessment

    Proportion of patients with a best overall response of confirmed CR or PR

    Measured: Up to 136 weeks from randomization

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

    The time from first response of CR or PR to first radiographic progression or death due to any cause for patients with confirmed CR or PR

    Measured: Up to 3 years from last patient randomized

  3. DOR by investigator assessment

    The time from first response of CR or PR to first radiographic progression or death due to any cause for patients with confirmed CR or PR

    Measured: Up to 3 years from last patient randomized

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

    The time from randomization to the date of the first radiographic progression or death due to any cause, whichever occurred earlier

    Measured: Up to 3 years from last patient randomized

  5. PFS by investigator assessment

    The time from randomization to the date of the first radiographic progression or death due to any cause, whichever occurred earlier

    Measured: Up to 3 years from last patient randomized

  6. Overall Survival (OS)

    The time from enrollment to the date of death due to any cause

    Measured: Up to 3 years from last patient randomized

  7. Incidence of treatment-emergent adverse events (TEAEs)

    A TEAE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.

    Measured: Up to 3 years

  8. Incidences of serious adverse events (SAEs)

    An SAE is any untoward medical occurrence that at any dose:

    • Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger)
    • Is life-threatening
    • Requires in-patient hospitalization or prolongation of existing hospitalization
    • Results in persistent or significant disability/incapacity
    • Is a congenital anomaly/birth defect
    • Is an important medical event

    Measured: Up to 3 years

  9. Incidences of deaths

    Measured: Up to 3 years

  10. Incidences of laboratory abnormalities

    According to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Causality grading system (≥ Grade 3 or higher)

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2022
  2. Study start21 Apr 2023
  3. Primary completion26 Jan 2028 (estimated)
  4. Study completion16 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05557591
Sponsor's protocol ID
R2810-ONC-2045
Other IDs
2021-006901-31, 2023-503221-19-00, 2023
Status last verified
May 2026
First submitted
23 Sep 2022
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BNT116 and Cemiplimab in people with Advanced Non-Small Cell Lung Cancer, run by Regeneron Pharmaceuticals at 52 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in Spain, United States, Turkey (Türkiye), South Korea, Georgia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Up to 136 weeks from randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05557591.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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