A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

Last updated: November 13, 2024
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2/3

Condition

N/A

Treatment

fianlimab

Placebo

cemiplimab

Clinical Study ID

NCT05785767
R3767-ONC-2235
2022-501483-18-00
  • Ages > 18
  • All Genders

Study Summary

This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab (also called REGN2810), individually called a "study drug" or collectively called "study drugs". The study is focused on patients who have advanced non-small cell lung cancer (NSCLC).

The aim of the study is to see how effective the combination of fianlimab and cemiplimab is in treating advanced NSCLC, in comparison with cemiplimab by itself.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drugs

  • How much 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

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Patients with non-squamous or squamous histology NSCLC with stage IIIB or stage IIICdisease who are not candidates for surgical resection or definitive chemoradiationper investigator assessment or stage IV (metastatic disease), who received no priorsystemic treatment for recurrent or metastatic NSCLC.

  2. Availability of an archival or on-study formalin-fixed, paraffin-embedded (FFPE)tumor tissue sample, without intervening therapy between biopsy collection andscreening as described in the protocol

  3. For enrollment in phase 2, patients should have PD-L1 levels ≥ 50%, as determined bya College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments (CLIA) (or equivalently licensed, according to local regulations) accreditedlaboratory, as described in the protocol. For enrollment in phase 3, patients shouldhave expression of programmed cell death ligand-1 (PD-L1) in ≥50% of tumor cellsstained using an assay performed by a central laboratory, as described in theprotocol.

  4. At least 1 radiographically measurable lesion by computed tomography (CT) ormagnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumorsversion 1.1 (RECIST 1.1) criteria. Target lesions may be located in a previouslyirradiated field if there is documented (radiographic) disease progression in thatsite.

  5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.

  6. Adequate organ and bone marrow function, as described in the protocol.

Exclusion

Key Exclusion Criteria:

  1. Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime.

  2. Active or untreated brain metastases or spinal cord compression. Patients areeligible if central nervous system (CNS) metastases are adequately treated, andpatients have neurologically returned to baseline (except for residual signs orsymptoms related to the CNS treatment) for at least 2 weeks prior to enrollment.Patients must be off (immunosuppressive doses of) corticosteroid therapy.

  3. Patients with tumors tested positive for actionable epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, orc-ros oncogene 1 (ROS1) fusions, as described in the protocol.

  4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment.

  5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis ororganizing pneumonia), of active, noninfectious pneumonitis that requiredimmune-suppressive doses of glucocorticoids to assist with management, or ofpneumonitis within the last 5 years. A history of radiation pneumonitis in theradiation field is permitted as long as pneumonitis resolved ≥6 months prior toenrollment.

  6. Known primary immunodeficiencies, either cellular (eg, DiGeorge syndrome,T-cell-negative severe combined immunodeficiency [SCID]) or combined T- and B-cellimmunodeficiencies (eg, T- and B-cell negative SCID, Wiskott Aldrich syndrome,ataxia telangiectasia, common variable immunodeficiency).

  7. Ongoing or recent (within 2 years) evidence of significant autoimmune disease thatrequired treatment with systemic immunosuppressive treatments, which may suggestrisk of immune-mediated treatment-emergent adverse events (imTEAEs). Patients withuncontrolled type 1 diabetes mellitus or with uncontrolled adrenal insufficiency areexcluded. The following are not exclusionary: vitiligo, childhood asthma that hasresolved, residual hypothyroidism that required only hormone replacement, orpsoriasis that does not require systemic treatment.

  8. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day orequivalent) within 14 days of randomization. Physiologic replacement doses areallowed even if they are >10 mg of prednisone/day or equivalent, as long as they arenot being administered for immunosuppressive intent. Patients with clinicallyrelevant systemic immune suppression within the last 3 months before trialenrollment are excluded. Inhaled or topical steroids are permitted, provided thatthey are not for treatment of an autoimmune disorder.

  9. Patients who have received prior systemic therapies are excluded with the exceptionof the following:

  10. Adjuvant or neoadjuvant platinum-based doublet chemotherapy (after surgeryand/or radiation therapy) if recurrent or metastatic disease develops more than 6 months after completing therapy as long as toxicities have resolved to CTCAEgrade ≤1 or baseline with the exception of alopecia and peripheral neuropathy.

  11. Anti-PD-(L) 1 with or without LAG-3 as an adjuvant or neoadjuvant therapy aslong as the last dose is >12 months prior to enrollment.

  12. Prior exposure to other immunomodulatory or vaccine therapies as an adjuvant orneoadjuvant therapy, 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 timeof enrollment. Endocrine immune-mediated AEs controlled with hormonal or othernon-immunosuppressive therapies without resolution prior to enrollment areallowed.

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.

Study Design

Total Participants: 850
Treatment Group(s): 3
Primary Treatment: fianlimab
Phase: 2/3
Study Start date:
June 30, 2023
Estimated Completion Date:
February 05, 2032

Connect with a study center

  • Macquarie University Health Science Center (MQ Health)

    Macquarie Park, New South Wales 2109
    Australia

    Active - Recruiting

  • Riverina Cancer Care Centre (RCCC)

    Wagga Wagga, New South Wales 2650
    Australia

    Active - Recruiting

  • Southern Medical Day Care Centre

    Wollongong, New South Wales 2500
    Australia

    Active - Recruiting

  • Ballarat Regional Integrated Cancer Centre (BRICC)

    Ballarat, Victoria 3350
    Australia

    Active - Recruiting

  • Bendigo Hospital

    Bendigo, Victoria 3550
    Australia

    Active - Recruiting

  • British Columbia Cancer Center- Kelowna

    Kelowna, British Columbia V1Y 5L3
    Canada

    Active - Recruiting

  • LTD Cancer Center of Adjara

    Batumi, Adjaria 6000
    Georgia

    Active - Recruiting

  • Israeli Georgian medical research clinic Helsicore

    Tbilisi, 0112
    Georgia

    Active - Recruiting

  • JSC Evex Hospitals- Caraps Medline

    Tbilisi, 179
    Georgia

    Active - Recruiting

  • JSC K. Eristavi National Center of Experimental and Clinical Surgery

    Tbilisi, 0159
    Georgia

    Active - Recruiting

  • Research Institute of Clinical Medicine

    Tbilisi, 112
    Georgia

    Active - Recruiting

  • TIM - Tbilisi Institute of Medicine

    Tbilisi, 0160
    Georgia

    Active - Recruiting

  • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

    Tbilisi, 144
    Georgia

    Active - Recruiting

  • The Institute of Clinical Oncology

    Tbilisi, 0159
    Georgia

    Active - Recruiting

  • Soroka University Medical Center

    Beer-Sheba, HaDarom 84101
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Assuta Medical Centers

    Tel Aviv, 6971028
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Active - Recruiting

  • Chungbuk National University Hospital

    Cheongju-si, Chungbuk 28644
    Korea, Republic of

    Active - Recruiting

  • Ajou University Hospital

    Suwon, Gyeonggi 16499
    Korea, Republic of

    Active - Recruiting

  • Jeonbuk National University Hospital

    Jeonju, Jeollabuk-do 54907
    Korea, Republic of

    Active - Recruiting

  • Chungnam National University Hospital

    Daejeon, 35015
    Korea, Republic of

    Active - Recruiting

  • Gachon University Gil Medical Center

    Incheon, 21565
    Korea, Republic of

    Active - Recruiting

  • Inha University Hospital

    Incheon, 22332
    Korea, Republic of

    Active - Recruiting

  • Korea University Guro Hospital

    Seoul, 8308
    Korea, Republic of

    Active - Recruiting

  • St. Vincent's Hospital, The Catholic University of Korea

    Suwon, 16247
    Korea, Republic of

    Active - Recruiting

  • Ulsan University Hospital

    Ulsan, 44033
    Korea, Republic of

    Active - Recruiting

  • Hospital Sultan Ismail

    Johor Bahru, Johor 81100
    Malaysia

    Active - Recruiting

  • Hospital Tengku Ampuan Afzan (HTTA)

    Kuantan, Pahang 25100
    Malaysia

    Active - Recruiting

  • Hospital Kuala Lumpur

    Kuala Lumpur, Wilayah Persekutuan 50586
    Malaysia

    Active - Recruiting

  • National Cancer Institute

    Putrajaya, Wilayah Persekutuan 62250
    Malaysia

    Active - Recruiting

  • Hospital Pulau Pinang

    Pulau Pinang, 10990
    Malaysia

    Active - Recruiting

  • Hualien Tzu Chi Medical Center

    Hualien, 97002
    Taiwan

    Site Not Available

  • Hualien Tzu Chi Medical Center

    Hualien City, 97002
    Taiwan

    Active - Recruiting

  • Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Active - Recruiting

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Active - Recruiting

  • Taipei Medical University Hospital

    Taipei, 110301
    Taiwan

    Active - Recruiting

  • Navamindradhiraj University

    Dusit, Bangkok 10300
    Thailand

    Active - Recruiting

  • Chiang Mai University

    Muang, Chiang Mai 50200
    Thailand

    Active - Recruiting

  • Prince Of Songkla Hospital, Prince Of Songkhla University

    Hat-Yai, Songkhla 90110
    Thailand

    Active - Recruiting

  • Lampang Cancer Center

    Lampang, 52000
    Thailand

    Active - Recruiting

  • Istinye University VMMedical Park Pendik Hospital

    Pendik, Istanbul 34899
    Turkey

    Active - Recruiting

  • Necmettin Erbakan University Meram Faculty of Medicine

    Konya, Meram 42080
    Turkey

    Active - Recruiting

  • Ondokuz Mayis University

    Kurupelit, Samsun 55139
    Turkey

    Active - Recruiting

  • Gaziantep Medicalpoint Hospital

    Gaziantep, Sehitkamil 27584
    Turkey

    Active - Recruiting

  • Gazi University

    Ankara, 06100
    Turkey

    Active - Recruiting

  • Gulhane Research and Training Hospital

    Ankara, 06010
    Turkey

    Active - Recruiting

  • Liv Hospital Ankara

    Ankara, 06100
    Turkey

    Active - Recruiting

  • Memorial Ankara Hospital

    Ankara, 906520
    Turkey

    Active - Recruiting

  • Sbu Dr.A.Y. Ankara Onkoloji Suam

    Ankara, 06100
    Turkey

    Active - Recruiting

  • Yuksek Ihtisas Unıversity Medicalpark Hospital

    Ankara, 06370
    Turkey

    Active - Recruiting

  • Trakya University

    Edirne, 22030
    Turkey

    Active - Recruiting

  • Istanbul Medeniyet University Prof.Dr.Suleyman Yalcin Şehir Hospital

    Istanbul, 81450
    Turkey

    Active - Recruiting

  • Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty

    Istanbul, 34450
    Turkey

    Active - Recruiting

  • Koc University

    Istanbul, 34010
    Turkey

    Active - Recruiting

  • Izmir Economy University Medical Point Hospital

    Izmir, 35325
    Turkey

    Active - Recruiting

  • Arizona Clinical Research Center

    Tucson, Arizona 85715
    United States

    Active - Recruiting

  • Yuma Regional Medical Center

    Yuma, Arizona 85364
    United States

    Active - Recruiting

  • Desert Hematology Oncology Medical Group, Inc.

    Rancho Mirage, California 92270
    United States

    Active - Recruiting

  • Emad Ibrahim, MD, Inc.

    Redlands, California 92373
    United States

    Active - Recruiting

  • Clermont Oncology Center

    Clermont, Florida 34711
    United States

    Active - Recruiting

  • Clerrmont Oncology Center

    Clermont, Florida 34711
    United States

    Active - Recruiting

  • Miami Veterans Administration HealthCare System

    Miami, Florida 33125
    United States

    Active - Recruiting

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida 32763
    United States

    Active - Recruiting

  • Pinellas Hematology and Oncology

    Saint Petersburg, Florida 33709
    United States

    Active - Recruiting

  • Tallahassee Memorial Healthcare

    Tallahassee, Florida 32308
    United States

    Active - Recruiting

  • University of Illinois

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana 70809
    United States

    Active - Recruiting

  • Hattiesburg Clinic

    Hattiesburg, Mississippi 39401
    United States

    Active - Recruiting

  • Capital Health Medical Center

    Pennington, New Jersey 08534
    United States

    Active - Recruiting

  • New Mexico Cancer Care Alliance/ University of New Mexico

    Albuquerque, New Mexico 87131-0001
    United States

    Active - Recruiting

  • New York Cancer and Blood Specialists

    Port Jefferson Station, New York 11776
    United States

    Active - Recruiting

  • Clinical Research Alliance, Inc.

    Westbury, New York 11590
    United States

    Active - Recruiting

  • Gabrail Cancer Center Research

    Canton, Ohio 44718
    United States

    Active - Recruiting

  • Thompson Cancer Survival Center (TCSC ) - Downtown

    Knoxville, Tennessee 37916-2300
    United States

    Active - Recruiting

  • University of Tennessee Medical Center

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

  • Renovatio Clinical

    El Paso, Texas 79915
    United States

    Active - Recruiting

  • University of Virginia Medical Center

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

  • Bon Secours Cancer Institute Richmond

    Midlothian, Virginia 23114
    United States

    Active - Recruiting

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