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Lung cancer vaccine combo shows promise in early trial

NCT ID NCT05557591

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether adding an mRNA vaccine (BNT116) to standard immunotherapy (cemiplimab) works better than immunotherapy alone for people with advanced non-small cell lung cancer. About 51 patients whose tumors have high PD-L1 levels will receive either the combination or just cemiplimab. The study aims to see if the vaccine helps shrink tumors and improve response rates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cemiplimab (an immunotherapy drug) and BNT116 (an mRNA vaccine)
What this could lead to
If it works, this combination could shrink tumors or slow cancer growth better than immunotherapy alone, offering a new treatment option for advanced lung cancer.
What could go wrong
This is a small, early-phase trial (51 people) with no results yet. The vaccine may not boost effectiveness, and side effects from the combination could be worse than with immunotherapy alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

51 people

The number who actually took part.

Started

Apr 2023

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key 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 Key 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. Note: Other protocol-defined Inclusion/Exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced non-small cell lung cancer

Contacts and locations

Locations

  • Adana Medical Park Seyhan Hospital

    Adana, Adana, 01140, Turkey (Türkiye)

  • Althaia Xarxa Assistencial Universitaria Manresa

    Manresa, Barcelona, 08243, Spain

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Baskent University

    Yüreğir, Adana, 01230, Turkey (Türkiye)

  • Bezmialem Foundation University Medical Faculty

    Istanbul, 34093, Turkey (Türkiye)

  • Catalan Institute of Oncology Badalona

    Badalona, Barcelona, 08916, Spain

  • Caucasus Medical Centre

    Tbilisi, 0186, Georgia

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128, South Korea

  • Clinica Universidad de Navarra

    Pamplona, 31008, Spain

  • Clinica Universidad de Navarra - Madrid

    Madrid, 28027, Spain

  • Consorcio Hospitalario Provincial de Castellon

    Castellon, Castellon, 12002, Spain

  • Ege University Faculty of Medicine

    Bornova, İzmir, 35100, Turkey (Türkiye)

  • FirstHealth of the Carolinas Outpatient Cancer Center

    Pinehurst, North Carolina, 28374, United States

  • Hospital General Universitario Gregorio Marañon (HGUGM)

    Madrid, 28007, Spain

  • Hospital Regional Universitario de Malaga

    Málaga, 29010, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario Virgen del Rocio

    Málaga, 29010, Spain

  • Instituto Valenciano de Oncologia

    Valencia, 46009, Spain

  • Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital

    Istanbul, 81450, Turkey (Türkiye)

  • Izmir Economy University Medical Point Hospital

    Izmir, 35325, Turkey (Türkiye)

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt

    Frankfurt, 60590, Germany

  • Klinikverbund Kempten-Oberallgäu

    Kempten, 87349, Germany

  • Korea University Anam Hospital

    Seoul, Gyeonggi-do, 02841, South Korea

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    Halle, 06120, Germany

  • LLC Todua Clinic

    Tbilisi, 0112, Georgia

  • LTD Cancer Research Centre

    Tbilisi, 0179, Georgia

  • LTD High Technology Hospital Medcenter

    Batumi, 6000, Georgia

  • LTD New Hospitals

    Tbilisi, 0114, Georgia

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

    Tbilisi, 0144, Georgia

  • Millenium Research & Clinical Development

    Houston, Texas, 77090, United States

  • National Cancer Center Korea

    Goyang, 10408, South Korea

  • National Taiwan University Hospital

    Taipei, 100225, Taiwan

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405, United States

  • Norton Cancer Institute, Downtown

    Louisville, Kentucky, 40202, United States

  • Ozel Liv Hospital

    Ankara, 06100, Turkey (Türkiye)

  • Samsung Medical Center

    Seoul, 6351, South Korea

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401, United States

  • Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam

    Ankara, 06100, Turkey (Türkiye)

  • Seoul National University Hospital

    Seoul, 744, South Korea

  • Staedtisches Klinikum Muenchen Bogenhausen

    München, Bavaria, 81925, Germany

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City, 23561, Taiwan

  • Taipei Tzu Chi Hospital

    New Taipei City, 23142, Taiwan

  • The Oncology Institute of Hope and Innovation

    Los Angeles, California, 90033, United States

  • Tri-Service General Hospital

    Taipei, 114, Taiwan

  • UCLA Medical Center

    Santa Monica, California, 90095, United States

  • Universitaetsklinikum Giessen Und Marburg Gmbh Standort Giessen

    Giessen, 80336, Germany

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

  • Yeditepe University Kosuyolu Hospital

    Kadıköy, Istanbul, 34718, Turkey (Türkiye)

  • Yonsei Severance

    Seoul, 3722, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.