ACTIVE_NOT_RECRUITING

A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer

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Conditions

Non-small Cell Lung CancerNSCLCLung cancerProgrammed cell death ligand-1PD-L1Lymphocyte-activation gene 3LAG-3African descent

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is researching an investigational drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and chemotherapy, individually called a "study drug" or collectively called "study drugs". 'Investigational' means that the study drug is not approved for use outside of this study by any Health Authority. Examples of chemotherapy drugs include the following: Paclitaxel plus carboplatin, and Pemetrexed plus cisplatin. The study is being conducted in patients who have advanced non-small cell lung cancer (NSCLC). The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is for treating advanced NSCLC, in comparison with cemiplimab and chemotherapy. 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 your blood at different times * Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects) * How administering the study drugs might improve your quality of life

Official Title

A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody), Cemiplimab (Anti-PD-1 Antibody), and Chemotherapy Versus Cemiplimab and Chemotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Irrespective of PD-L1 Expression Levels

Quick Facts

Study Start:2023-08-08
Study Completion:2031-12-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05800015

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients 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. 2. Availability of an archival or on-study formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample, without intervening therapy between biopsy collection and screening as described in the protocol
  3. 3. For enrollment in phase 2, patients should have PD-L1, expression results (regardless of expression level) determined by a College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments (CLIA) (or equivalently licensed, according to local regulations) accredited laboratory, as described in the protocol. For enrollment in phase 3, patients should have a valid PD-L1 result, regardless of expression level, using an assay as performed by a central laboratory, as described in the protocol.
  4. 4. At least 1 radiographically measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site.
  5. 5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
  6. 6. Adequate organ and bone marrow function as defined in the protocol.
  1. 1. Active or untreated brain metastases or spinal cord compression. Patients 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. Patients must be off (immunosuppressive doses of) corticosteroid therapy.
  2. 2. Patients with tumors tested positive for actionable epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or ROS oncogene 1 (ROS1) fusions, as described in the protocol.
  3. 3. Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment.
  4. 4. 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. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to enrollment.
  5. 5. Known primary immunodeficiencies, either cellular (eg, DiGeorge syndrome, T-cell-negative severe combined immunodeficiency \[SCID\]) or combined T- and B-cell immunodeficiencies (eg, T- and B-cell negative SCID, Wiskott Aldrich syndrome, ataxia telangiectasia, common variable immunodeficiency).
  6. 6. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk of immune-mediated treatment-emergent adverse events (imTEAEs). Patients with uncontrolled type 1 diabetes mellitus or with uncontrolled adrenal insufficiency are excluded. The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.
  7. 7. Patients with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of randomization. Physiologic replacement doses are allowed even if they are \>10 mg of prednisone/day or equivalent, as long as they are not being administered for immunosuppressive intent. Patients with clinically relevant systemic immune suppression within the last 3 months before trial enrollment are excluded. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder.
  8. 8. Patients who have received prior systemic therapies are excluded with the exception of the following:
  9. 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.
  10. 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.
  11. 3. Prior exposure to other immunomodulatory or vaccine as an adjuvant or neoadjuvant therapy such as Cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibodies as long as the last dose is \>6 months prior to enrollment. Immune-mediated AEs must be resolved to CTCAE grade ≤1 or baseline by the time of enrollment. Endocrine immune-mediated AEs controlled with hormonal or other non-immunosuppressive therapies without resolution prior to enrollment are allowed.

Contacts and Locations

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

Arizona Clinical Research Center
Tucson, Arizona, 85715
United States
Yuma Regional Medical Center
Yuma, Arizona, 85364
United States
The Oncology Institute of Hope & Innovation
Cerritos, California, 90703
United States
Crosson Cancer Institute
Fullerton, California, 92835
United States
St. Joseph Hospital Orange
Orange, California, 92868
United States
Desert Hematology Oncology Medical Group Incorporated
Rancho Mirage, California, 92270
United States
Emad Ibrahim, MD, Inc.
Redlands, California, 92373
United States
PIH Health Hospital
Whittier, California, 90602
United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
United States
Yale Cancer Center
New Haven, Connecticut, 06519
United States
Clermont Oncology Center
Clermont, Florida, 34711
United States
Miami Veterans Administration HealthCare System
Miami, Florida, 33125
United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
United States
Tallahassee Memorial Healthcare
Tallahassee, Florida, 32308
United States
University of Illinois
Chicago, Illinois, 60612
United States
Northwest Oncology and Hematology
Rolling Meadows, Illinois, 60008
United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
United States
Capital Health Hopewell Medical Center
Pennington, New Jersey, 08534
United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, 87102
United States
NYU Langone Health Perlmutter Cancer Center
New York, New York, 10016
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Montefiore Medical Center
The Bronx, New York, 10461
United States
Clinical Research Alliance Inc
Westbury, New York, 11590
United States
Gabrail Cancer Center Research
Canton, Ohio, 44718
United States
Thompson Cancer Survival Center (TCSC ) - Downtown
Knoxville, Tennessee, 37916
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908
United States
Bon Secours Cancer Institute Richmond
Midlothian, Virginia, 23114
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-08
Study Completion Date2031-12-23

Study Record Updates

Study Start Date2023-08-08
Study Completion Date2031-12-23

Terms related to this study

Keywords Provided by Researchers

  • NSCLC
  • Lung cancer
  • Programmed cell death ligand-1
  • PD-L1
  • Lymphocyte-activation gene 3
  • LAG-3
  • African descent

Additional Relevant MeSH Terms

  • Non-small Cell Lung Cancer