A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)

Purpose

This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer for whom surgery is planned. The aim is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug. The study is also looking at several other research questions, including: - What are the side effects associated with the investigational treatments in comparison to the control treatment? - Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed? - How much of the study drug(s) are in the blood at a given time? - Does the body make antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)?

Condition

  • Non-Small Cell Lung Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol 2. Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 3. Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol 4. Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1 5. Adequate organ and bone marrow function, as described in the protocol General

Exclusion Criteria

  1. Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol 2. Presence of known oncogenic alterations in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) in the tumor prior to randomization, as described in the protocol 3. Presence of grade≥ 2 peripheral neuropathy 4. Another malignancy that is progressing or requires active treatment, as described in the protocol Arm Specific Exclusion Criteria: Arm 1: 1. Grade ≥3 hypercalcemia, as defined in the protocol 2. Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol 3. Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram (QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol Note: Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Chemotherapy+Cemiplimab 		Control treatment
  • Drug: Cemiplimab
    Intravenous (IV) infusion administration
    Other names:
    • REGN2810
    • LIBTAYO
  • Drug: Platinum-based chemotherapy
    IV infusion
  • Drug: REGN7075
    IV infusion
    Other names:
    • EGFRxCD28 bispecific immunotherapy
Experimental
Arm 1: Chemotherapy+Cemiplimab+REGN7075 		Investigational Treatment
  • Drug: Cemiplimab
    Intravenous (IV) infusion administration
    Other names:
    • REGN2810
    • LIBTAYO
  • Drug: Platinum-based chemotherapy
    IV infusion
  • Drug: REGN7075
    IV infusion
    Other names:
    • EGFRxCD28 bispecific immunotherapy

Recruiting Locations

University of California Irvine
Orange, California 92868

Orchard Healthcare Research Inc.
Skokie, Illinois 60077

Karmanos Cancer Institute
Detroit, Michigan 48201

Detroit Clinical Research Center
Farmington Hills, Michigan 48334

Morristown Medical Center
Morristown, New Jersey 07960

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901

Oncology Hematology Care Clinical Trials LLC
Cincinnati, Ohio 45245

Providence Portland Medical Center
Portland, Oregon 97213

University Of Nebraska Medical Center
Portland, Oregon 97213

Lifespan Cancer Institute
Providence, Rhode Island 02903

Prairie Lakes Healthcare System
Watertown, South Dakota 57201

University of Tennessee Medical Center
Knoxville, Tennessee 37920

Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee 37203

Tennessee Oncology
Nashville, Tennessee 37203

BRCC/Oncology & Hematology Associates of SW Virginia
Blacksburg, Virginia 24060

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

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