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NCT05557591 | RECRUITING | Advanced Non-Small Cell Lung Cancer

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)
Sponsor:

Regeneron Pharmaceuticals

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)

Condition or disease

Advanced Non-Small Cell Lung Cancer

Intervention/treatment

BNT116

Cemiplimab

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
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%
Actual Study Start Date : 2023-04-21
Estimated Primary Completion Date : 2027-03-02
Estimated Study Completion Date : 2027-06-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
    • 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)

    Location Details

    NCT05557591

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, California

    The Oncology Institute of Hope and Innovation

    Los Angeles, California, United States, 90033

    WITHDRAWN

    United States, California

    University of California Irvine

    Orange, California, United States, 92697

    RECRUITING

    United States, California

    UCLA Medical Center

    Santa Monica, California, United States, 90095

    RECRUITING

    United States, Kentucky

    Norton Cancer Institute, Downtown

    Louisville, Kentucky, United States, 40202

    WITHDRAWN

    United States, Massachusetts

    Dana Farber/Harvard Cancer Center

    Boston, Massachusetts, United States, 02215

    WITHDRAWN

    United States, New Mexico

    San Juan Oncology Associates

    Farmington, New Mexico, United States, 87401

    RECRUITING

    United States, New York

    Weill Cornell Medicine

    New York, New York, United States, 10065

    WITHDRAWN

    United States, North Carolina

    Oncology Specialists of Charlotte PA

    Charlotte, North Carolina, United States, 28207

    RECRUITING

    United States, North Carolina

    FirstHealth of the Carolinas Outpatient Cancer Center

    Pinehurst, North Carolina, United States, 28374

    TERMINATED

    United States, Texas

    Millenium Research & Clinical Development

    Houston, Texas, United States, 77090

    RECRUITING

    United States, Virginia

    Virginia Cancer Specialists

    Fairfax, Virginia, United States, 22031

    RECRUITING

    United States, Washington

    Northwest Medical Specialties, PLLC

    Tacoma, Washington, United States, 98405

    RECRUITING

    Georgia,

    LTD High Technology Hospital Medcenter

    Batumi, Georgia, 6000

    RECRUITING

    Georgia,

    LLC Todua Clinic

    Tbilisi, Georgia, 0112

    RECRUITING

    Georgia,

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

    Tbilisi, Georgia, 0144

    RECRUITING

    Georgia,

    LTD New Hospitals

    Tbilisi, Georgia, 0162

    RECRUITING

    Georgia,

    LTD Cancer Research Centre

    Tbilisi, Georgia, 0179

    RECRUITING

    Georgia,

    Caucasus Medical Centre

    Tbilisi, Georgia, 0186

    RECRUITING

    Germany, Bavaria

    Staedtisches Clinic Muenchen Bogenhausen

    Munich, Bavaria, Germany, 81925

    RECRUITING

    Germany,

    Clinic of Johann Wolfgang Goethe University Frankfurt

    Frankfurt, Germany, 60590

    NOT YET RECRUITING

    Germany,

    Universitaetsklinikum Giessen and Marburg GmbH location Giessen

    Pour, Germany, 80336

    RECRUITING

    Germany,

    Hospital Martha-Maria Halle-Doelau gGmbH

    Halle, Germany, 06120

    RECRUITING

    Germany,

    Kempten-Oberallgäu Clinic Association

    Kempten, Germany, 87349

    RECRUITING

    Korea, Republic of, Gyeonggi

    Korea University Anam Hospital

    Seoul, Gyeonggi, Korea, Republic of, 02841

    RECRUITING

    Korea, Republic of, Jeonnam

    Chonnam National University Hwasun Hospital

    Hwasun, Jeonnam, Korea, Republic of, 58128

    RECRUITING

    Korea, Republic of,

    National Cancer Center Korea

    Shake, Korea, Republic of, 10408

    NOT YET RECRUITING

    Korea, Republic of,

    Asan Medical Center

    Seoul, Korea, Republic of, 05505

    NOT YET RECRUITING

    Korea, Republic of,

    4th generation, the turbulent era

    Seoul, Korea, Republic of, 3722

    RECRUITING

    Korea, Republic of,

    Samsung Medical Center

    Seoul, Korea, Republic of, 6351

    RECRUITING

    Korea, Republic of,

    Seoul National University Hospital

    Seoul, Korea, Republic of, 744

    RECRUITING

    Spain, Barcelona

    Catalan Institute of Oncology Badalona

    Badalona, Barcelona, Spain, 08916

    RECRUITING

    Spain, Barcelona

    Althaia University Assistance Network Manresa

    Manresa, Barcelona, Spain, 08243

    RECRUITING

    Spain, Castellon

    Castellon Provincial Hospital Consortium

    Castle of the Plain, Castellon, Spain, 12002

    RECRUITING

    Spain,

    Gregorio Marañon University General Hospital (HGGM)

    Madrid, Spain, 28007

    RECRUITING

    Spain,

    Clinic University of Navarra - Madrid

    Madrid, Spain, 28027

    RECRUITING

    Spain,

    Jimenez Diaz Foundation University Hospital

    Madrid, Spain, 28040

    RECRUITING

    Spain,

    Regional University Hospital of Malaga

    Malaga, Spain, 29010

    RECRUITING

    Spain,

    Virgen del Rocio University Hospital

    Malaga, Spain, 29010

    RECRUITING

    Spain,

    Clinic University of Navarra

    Pamplona, Spain, 31008

    NOT YET RECRUITING

    Spain,

    Valencian Institute of Oncologia

    Valencia, Spain, 46009

    RECRUITING

    Spain,

    University Hospital I POLITECNIC THE FAITH OF VALENCIA

    Valencia, Spain, 46026

    NOT YET RECRUITING

    Taiwan,

    Medical University.

    composed, Taiwan, 807

    RECRUITING

    Taiwan,

    Taipei Tzu Chi Hospital

    New Taipei City, Taiwan, 23142

    NOT YET RECRUITING

    Taiwan,

    Taipei Medical University - Shuang Ho Hospital

    New Taipei City, Taiwan, 23561

    RECRUITING

    Taiwan,

    Tri-Service General Hospital

    Taipei City, Taiwan, 114

    NOT YET RECRUITING

    Taiwan,

    National Taiwan University Hospital

    Taipei, Taiwan, 100225

    RECRUITING

    Turkey, Adana

    Basque University

    Eurgir, Adana, Turkey, 01230

    RECRUITING

    Turkey, Istanbul

    Yeditepe University Kosuyolu Hospital

    Kadikoy, Istanbul, Turkey, 34718

    RECRUITING

    Turkey, Izmir

    Ege University Faculty of Medicine

    Bornova, Izmir, Turkey, 35100

    RECRUITING

    Turkey, Seyhan

    Adana Medical Park Seyhan Hospital

    Adana, Seyhan, Turkey, 01140

    RECRUITING

    Turkey,

    Ozel Liv Hospital

    Ankara, Turkey, 06100

    RECRUITING

    Turkey,

    Sbu Doctor Abdurrahman Yurataslan Ankara Onkoloji husband

    Ankara, Turkey, 06100

    RECRUITING

    Turkey,

    Ankara Bilkent City Hospital

    Ankara, Turkey, 06800

    NOT YET RECRUITING

    Turkey,

    Bezmialem Foundation University Medical Faculty

    Istanbul, Turkey, 34093

    WITHDRAWN

    Turkey,

    IAU VM Medical Park Hospital

    Istanbul, Turkey, 34295

    RECRUITING

    Turkey,

    Prof. Dr. Istanbul Medeniyet University Dr. Suleyman Yalcin Eşe City Hospital

    Istanbul, Turkey, 81450

    RECRUITING

    Turkey,

    Izmir Economy University Medical Point Hospital

    Izmir, Turkey, 35325