Lung Cancer Clinical Trial

Safety and Efficacy of Intravenous Cemiplimab Plus BNT116 Versus Cemiplimab Alone in Advanced Non-Small Cell Lung Cancer in Adult Participants With PD-L1 ≥ 50%

Summary

The 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" in this form. The study is focused on patients who have advanced non-small cell lung cancer (NSCLC).

The aims of the 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 your 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 your 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)

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria

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) in ≥50% of tumor cells stained using the VENTANA PD-L1 (SP263) Assay as performed by a central laboratory
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

Key Exclusion Criteria

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, with the exception of 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 with the exception 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 as long as toxicities have resolved to CTCAE grade ≤1 or baseline with the exception of 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 as long as 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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT05557591

Recruitment Status:

Recruiting

Sponsor:

Regeneron Pharmaceuticals

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There are 40 Locations for this study

See Locations Near You

The Oncology institute of Hope and Innovation
Los Angeles California, 90033, United States
University of California Irvine
Orange California, 92697, United States
UCLA Medical Center
Santa Monica California, 90095, United States
Norton Cancer Institute, Downtown
Louisville Kentucky, 40202, United States
Dana Farber/Harvard Cancer Center
Boston Massachusetts, 02215, United States
San Juan Oncology Associates
Farmington New Mexico, 87401, United States
Oncology Specialists of Charlotte Pa
Charlotte North Carolina, 28204, United States
FirstHealth of the Carolinas, Inc.
Pinehurst North Carolina, 28374, United States
Millenium Research & Clinical Development
Houston Texas, 77090, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Northwest Medical Specialties, PLLC
Tacoma Washington, 98405, United States
LTD High Technology Hospital Medcenter
Batumi , 6000, Georgia
LLC Todua Clinic
Tbilisi , 0112, Georgia
LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi , 0144, Georgia
LTD New Hospitals
Tbilisi , 0162, Georgia
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
Frankfurt am Main , 60590, Germany
Universitaetsklinikum Giessen Und Marburg Gmbh Standort Giessen
Giessen , 80336, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle , 6120, Germany
Klinikverbund Kempten-Oberallgäu
Kempten , 87439, Germany
Staedtisches Klinikum Muenchen Bogenhausen
Muenchen , 81925, Germany
Catalan Institute of Oncology Badalona
Badalona , 08916, Spain
Althaia, Xarxa Assistencial Universitària Manresa
Barcelona , 08243, Spain
Consorcio hospitalario provincial de castellon
Castello , 12002, Spain
Hospital General Universitario Gregorio Marañon (HGUGM)
Madrid , 28007, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Regional Universitario de Málaga
Malaga , 29010, Spain
Hospital Universitario Virgen del Rocio
Malaga , 29010, Spain
Clinica Universidad de Navarra
Pamplona , 31008, Spain
Instituto Valenciano de Oncologia
Valencia , 46009, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia , 46026, Spain
Baskent University Faculty of Medicine Ankara Hospital
Ankara Bahcelievler, 06490, Turkey
Yeditepe University Kosuyolu Hospital
Kadikoy Istanbul, 34718, Turkey
Ege University Medical Faculty
Bornova Izmir, 35040, Turkey
Sbu Dr. A.Y. Ankara Onkoloji Suam
Ankara , 06100, Turkey
Liv Hospital
Ankara , 06680, Turkey
Ankara Bilkent Sehir Hastanesi
Ankara , 06800, Turkey
Bezmialem Foundation University Medical Faculty
Istanbul , 34093, Turkey
IAU VM Medical Park Hospital
Istanbul , 34295, Turkey
Istanbul Medeniyet University Prof. Dr. Suleyman Yalcin Sehir Hospital
Istanbul , 81450, Turkey
Izmir Medicalpark Hospital
Izmir , 35000, Turkey
Medical Park Seyhan Hospital
Seyhan , 01140, Turkey

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT05557591

Recruitment Status:

Recruiting

Sponsor:


Regeneron Pharmaceuticals

How clear is this clinincal trial information?

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