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Clinical Trials in the USA / NCT05785767
Active, not recruiting Phase 2/3

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)

NCT05785767 · tracked via the Priya Life Science USA tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 2/3
Started
2023-06-30
Last updated
2026-07-02

Condition(s) studied

Advanced Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

fianlimabcemiplimabPlacebo

fianlimab: Administered per the protocol

cemiplimab: Administered per the protocol

Placebo: Administered per the protocol

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: 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. 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. For enrollment in phase 2, patients should have PD-L1 levels ≥ 50%, as 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 4. At least 1 radiographically measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (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. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1. 6. Adequate organ and bone marrow function, as described in the protocol. 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 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. 3. Patients with tumors tested positive for actionable epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or c-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 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. 6. 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). 7. 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. 8. 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. 9. Patients who have received prior systemic therapies 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, 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. Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.

Primary outcome measure(s)

Trial sites (106)

FacilityCityRegionStatus
Arizona Clinical Research Center Tucson Arizona
Yuma Regional Medical Center Yuma Arizona
Emad Ibrahim, MD, Inc. Redlands California
Eastern CT Hematology and Oncology Associates Norwich Connecticut
Clermont Oncology Center Clermont Florida
Miami Veterans Administration HealthCare System Miami Florida
Mid Florida Hematology and Oncology Center Orange City Florida
Pinellas Hematology and Oncology St. Petersburg Florida
Tallahassee Memorial Healthcare Tallahassee Florida
Moffitt Cancer Center Tampa Florida
University of Illinois Chicago Illinois
Mary Bird Perkins Cancer Center Baton Rouge Louisiana
Hattiesburg Clinic Hattiesburg Mississippi
Mercy South St Louis Missouri
St. Vincent Healthcare Billings Montana
New Mexico Cancer Care Alliance Albuquerque New Mexico
Clinical Research Alliance Inc Westbury New York
Gabrail Cancer Center Research Canton Ohio
University of Tennessee Medical Center Knoxville Tennessee
Renovatio Clinical El Paso Texas
MD Anderson Cancer Center Houston Texas
University of Virginia Medical Center Charlottesville Virginia
Bon Secours Cancer Institute Richmond Midlothian Virginia
Macquarie University Health Science Center (MQ Health) Macquarie Park New South Wales
Riverina Cancer Care Centre (RCCC) Wagga Wagga New South Wales
Southern Medical Day Care Centre Wollongong New South Wales
Ballarat Regional Integrated Cancer Centre (BRICC) Ballarat Victoria
Bendigo Hospital Bendigo Victoria
British Columbia Cancer Center-Kelowna Kelowna British Columbia
Cancer Center of Adjara Batumi Adjara
Israeli Georgian Medical Research Clinic Helsicore Tbilisi Georgia
Research Institute of Clinical Medicine Tbilisi Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic Tbilisi Georgia
NNLE New Vision University Hospital Tbilisi Georgia
The Institute of Clinical Oncology Tbilisi Georgia
TIM - Tbilisi Institute of Medicine Tbilisi Georgia
JSC Evex Hospitals - Caraps Medline Tbilisi Georgia
Soroka University Medical Center Beersheba Southern District
Shaare Zedek Medical Center Jerusalem Israel
Tel Aviv Sourasky Medical Center Tel Aviv Israel

+ 66 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05785767 on ClinicalTrials.gov ↗ ← All trials in the USA