Print

Purpose

This study is researching an experimental drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and platinum-doublet chemotherapy, individually called a "study drug" or collectively called "study drugs", when combined in this study. The study is being conducted in patients who have resectable stage II to IIIB (N2) non-small cell lung cancer (NSCLC) that can be treated with surgery. The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is in comparison with cemiplimab and chemotherapy as peri-operative therapy in participants with NSCLC. The study is looking at several other research questions, including: - What side effects may happen from taking the study drugs - How much of each study drug is in the blood at different times - Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects) - How administering the study drugs might affect quality of life

Condition

Eligibility

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

Inclusion Criteria

  1. Patients with newly diagnosed, histologically confirmed, fully resectable stage II to IIIB (N2) NSCLC as per American Joint Committee on Cancer (AJCC) version 8 2. For patients with evidence of mediastinal adenopathy on imaging, mediastinal lymph node sampling is required as defined in the protocol 3. All patients must have disease status showing no evidence of distant metastases documented by a complete physical examination and imaging studies performed within 4 weeks prior to randomization as defined in the protocol 4. A patient must have an evaluable Programmed cell death ligand-1 (PD-L1) immunohistochemistry (IHC) result as defined in the protocol 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. Adequate bone marrow, hepatic and kidney function as defined in the protocol

Exclusion Criteria

  1. Any evidence of locally advanced unresectable or metastatic disease as defined in the protocol 2. Patients with tumors with known Epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations as defined in the protocol 3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection as defined in the protocol 4. Treatment with anti-cancer therapy including immunotherapy, chemotherapy, radiotherapy, or biological therapy in the 3 years prior to randomization. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed. 5. Patients with a history of myocarditis 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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A 		Randomized 1:1:1 Neoadjuvant period: placebo + cemiplimab + platinum doublet chemotherapy Adjuvant period: placebo + cemiplimab
  • Drug: Cemiplimab
    Administered IV Q3W
    Other names:
    • REGN2810
    • Libtayo
  • Drug: Pemetrexed
    Administered IV Q3W
    Other names:
    • Alimta
  • Drug: Paclitaxel
    Administered IV Q3W
    Other names:
    • Taxol
  • Drug: Carboplatin
    Administered IV Q3W
    Other names:
    • Paraplatin
  • Drug: Cisplatin
    Administered IV Q3W
    Other names:
    • Platinol
  • Drug: Placebo
    Administered IV Q3W
Experimental
Arm B 		Randomized 1:1:1 Neoadjuvant period: fianlimab high dose + cemiplimab + platinum doublet chemotherapy Adjuvant period: fianlimab high dose + cemiplimab
  • Drug: Fianlimab
    Administered intravenously (IV) every 3 weeks (Q3W)
    Other names:
    • REGN3767
  • Drug: Cemiplimab
    Administered IV Q3W
    Other names:
    • REGN2810
    • Libtayo
  • Drug: Pemetrexed
    Administered IV Q3W
    Other names:
    • Alimta
  • Drug: Paclitaxel
    Administered IV Q3W
    Other names:
    • Taxol
  • Drug: Carboplatin
    Administered IV Q3W
    Other names:
    • Paraplatin
  • Drug: Cisplatin
    Administered IV Q3W
    Other names:
    • Platinol
Experimental
Arm C 		Randomized 1:1:1 Neoadjuvant period: fianlimab low dose + cemiplimab + platinum doublet chemotherapy Adjuvant Period: fianlimab low dose + cemiplimab
  • Drug: Fianlimab
    Administered intravenously (IV) every 3 weeks (Q3W)
    Other names:
    • REGN3767
  • Drug: Cemiplimab
    Administered IV Q3W
    Other names:
    • REGN2810
    • Libtayo
  • Drug: Pemetrexed
    Administered IV Q3W
    Other names:
    • Alimta
  • Drug: Paclitaxel
    Administered IV Q3W
    Other names:
    • Taxol
  • Drug: Carboplatin
    Administered IV Q3W
    Other names:
    • Paraplatin
  • Drug: Cisplatin
    Administered IV Q3W
    Other names:
    • Platinol

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.