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Clinical Trials in the USA / NCT05800015
Active, not recruiting Phase 2/3

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

NCT05800015 · tracked via the Priya Life Science USA tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 2/3
Started
2023-08-08
Last updated
2026-07-15

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

fianlimab →cemiplimab →Pemetrexed →Paclitaxel →Carboplatin →Cisplatin →Placebo

fianlimab: Administered intravenously (IV) every 3 weeks (Q3W)

cemiplimab: Administered IV Q3W

Pemetrexed: IV Infusion, Q3W

Paclitaxel: IV Infusion, Q3W

Carboplatin: IV Infusion, Q3W

Cisplatin: IV infusion, Q3W

Placebo: IV infusion, Q3W

Study summary

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

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, 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. 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. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1. 6. Adequate organ and bone marrow function as defined in the protocol. Key Exclusion Criteria: 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. 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. Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment. 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. 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. 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. 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. 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 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. Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Primary outcome measure(s)

Trial sites (76)

FacilityCityRegionStatus
Arizona Clinical Research Center Tucson Arizona
Yuma Regional Medical Center Yuma Arizona
The Oncology Institute of Hope & Innovation Cerritos California
Crosson Cancer Institute Fullerton California
St. Joseph Hospital Orange Orange California
Desert Hematology Oncology Medical Group Incorporated Rancho Mirage California
Emad Ibrahim, MD, Inc. Redlands California
PIH Health Hospital Whittier California
Rocky Mountain Regional VA Medical Center Aurora Colorado
Yale Cancer Center New Haven Connecticut
Clermont Oncology Center Clermont Florida
Miami Veterans Administration HealthCare System Miami Florida
Mid Florida Hematology and Oncology Center Orange City Florida
Tallahassee Memorial Healthcare Tallahassee Florida
University of Illinois Chicago Illinois
Northwest Oncology and Hematology Rolling Meadows Illinois
Mary Bird Perkins Cancer Center Baton Rouge Louisiana
Hattiesburg Clinic Hattiesburg Mississippi
Capital Health Hopewell Medical Center Pennington New Jersey
New Mexico Cancer Care Alliance Albuquerque New Mexico
NYU Langone Health Perlmutter Cancer Center New York New York
Icahn School of Medicine at Mount Sinai New York New York
Montefiore Medical Center The Bronx New York
Clinical Research Alliance Inc Westbury New York
Gabrail Cancer Center Research Canton Ohio
Thompson Cancer Survival Center (TCSC ) - Downtown Knoxville Tennessee
University of Tennessee Medical Center Knoxville Tennessee
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
Southern Medical Day Care Centre Wollongong New South Wales
Ballarat Regional Integrated Cancer Centre (BRICC) Ballarat Victoria
Bendigo Hospital Bendigo Victoria
St Vincents Hospital Melbourne Fitzroy Victoria
St John of God Murdoch Hospital Murdoch Western Australia
British Columbia Cancer Center-Kelowna Kelowna British Columbia
Hopital Cite de la Sante Laval Quebec
LLC High-Tech Hospital Medcenter Batumi Adjara
Israeli Georgian Medical Research Clinic Helsicore Tbilisi Georgia
Research Institute of Clinical Medicine Tbilisi Georgia

+ 36 more sites — see the full list on the official registry below.

On this site

📄 Libtayo (cemiplimab) drug profile →

More Regeneron Pharmaceuticals trials in the USA

Other trials for the same condition

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 NCT05800015 on ClinicalTrials.gov ↗ ← All trials in the USA