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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%

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05557591
Recruitment Status : Recruiting
First Posted : September 28, 2022
Last Update Posted : April 23, 2024
Sponsor:
Collaborator:
BioNTech SE
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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Brief 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)

Condition or disease Intervention/treatment Phase
Advanced Non-Small Cell Lung Cancer Drug: BNT116 Drug: Cemiplimab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 : April 21, 2023
Estimated Primary Completion Date : March 2, 2027
Estimated Study Completion Date : June 7, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 2: Cemiplimab
Arm A: Cemiplimab is administered by IV infusion Q3W
 Drug: Cemiplimab
Cemiplimab is administered Q3W by IV infusion
Other Names:
  • REGN2810
  • Libtayo
Experimental: Phase 2: BNT116 + Cemiplimab
Arm B: BNT116 is administered by IV injection. Cemiplimab is administered by IV infusion Q3W.
 Drug: BNT116
BNT116 is administered by IV injection.

Drug: Cemiplimab
Cemiplimab is administered Q3W by IV infusion
Other Names:
  • REGN2810
  • Libtayo


Outcome Measures
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Primary Outcome Measures :
  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) [ Time Frame: Up to 136 weeks from randomization ]
    Proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR)


Secondary Outcome Measures :
  1. ORR by investigator assessment [ Time Frame: Up to 136 weeks from randomization ]
    Proportion of patients with a best overall response of confirmed CR or PR

  2. Duration of Response (DOR) as assessed by BIRC using RECIST 1.1 [ Time Frame: Up to 3 years from last patient randomized ]
    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

  3. DOR by investigator assessment [ Time Frame: Up to 3 years from last patient randomized ]
    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

  4. Progression Free Survival (PFS) as assessed by BIRC using RECIST 1.1 [ Time Frame: Up to 3 years from last patient randomized ]
    The time from randomization to the date of the first radiographic progression or death due to any cause, whichever occurred earlier

  5. PFS by investigator assessment [ Time Frame: Up to 3 years from last patient randomized ]
    The time from randomization to the date of the first radiographic progression or death due to any cause, whichever occurred earlier

  6. Overall Survival (OS) [ Time Frame: Up to 3 years from last patient randomized ]
    The time from enrollment to the date of death due to any cause

  7. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 3 years ]
    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.

  8. Incidences of serious adverse events (SAEs) [ Time Frame: Up to 3 years ]

    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

  9. Incidences of deaths [ Time Frame: Up to 3 years ]
  10. Incidences of laboratory abnormalities [ Time Frame: Up to 3 years ]
    According to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Causality grading system (≥ Grade 3 or higher)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) in ≥50% of tumor cells stained using the VENTANA PD-L1 (SP263) Assay as performed by a central laboratory
  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, 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
  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 with the exception 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 as long as toxicities have resolved to CTCAE grade ≤1 or baseline with the exception of 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 as long as 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05557591


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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Sponsors and Collaborators
Regeneron Pharmaceuticals
BioNTech SE
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
More Information
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05557591    
Other Study ID Numbers: R2810-ONC-2045
2021-006901-31 ( EudraCT Number )
2023-503221-19-00 ( Registry Identifier: EUCT )
First Posted: September 28, 2022    Key Record Dates
Last Update Posted: April 23, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data 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, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Cancer Vaccine
Immunotherapy
Programmed cell death ligand-1 (PD-L1) monoclonal antibody
Treatment naïve Advanced Non-Small Cell Lung Cancer (NSCLC)
EMPOWERVAX Lung 1
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents