Lung Cancer Clinical Trial

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)

Summary

The 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" in this form. 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

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

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.
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
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. For enrollment in phase 3, patients should have expression of programmed cell death ligand-1 (PD-L1) in ≥50% of tumor cells stained using an assay performed by a central laboratory, as described in the protocol.
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.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
Adequate organ and bone marrow function, as described in the protocol.

Key Exclusion Criteria:

Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime.
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.
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.
Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment.
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.
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).
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.
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.

Patients who have received prior systemic therapies are excluded with the exception of the following:

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.
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.
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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

850

Study ID:

NCT05785767

Recruitment Status:

Recruiting

Sponsor:

Regeneron Pharmaceuticals

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There are 36 Locations for this study

See Locations Near You

Yuma Regional Medical Center
Yuma Arizona, 85364, United States More Info
Abhinav Chandra, MD
Contact
[email protected]
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage California, 92270, United States More Info
Luke P Dreisbach, MD
Contact
[email protected]
Emad Ibrahim, MD, Inc.
Redlands California, 92373, United States More Info
Emad Ibrahim, MD
Contact
[email protected]
Clerrmont Oncology Center
Clermont Florida, 34711, United States More Info
Gopal Kunta, md
Contact
[email protected]
Miami Veterans Administration HealthCare System
Miami Florida, 33125, United States More Info
Niramol Savaraj, MD
Contact
[email protected]
Mid Florida Hematology and Oncology Center
Orange City Florida, 32763, United States More Info
Santosh M Nair, MD
Contact
[email protected]
Mary Bird Perkins Cancer Center
Baton Rouge Louisiana, 70809, United States More Info
Victor Lin, MD
Contact
[email protected]
Hattiesburg Clinic
Hattiesburg Mississippi, 39401, United States More Info
John Hrom
Contact
[email protected]
Capital Health Medical Center
Pennington New Jersey, 08534, United States More Info
Arturo Loaiza-Bonilla, MD
Contact
[email protected]
New York Cancer and Blood Specialists
Port Jefferson Station New York, 11776, United States More Info
Richard Zuniga, MD
Contact
[email protected]
Clinical Research Alliance, Inc.
Westbury New York, 11590, United States More Info
James D'Olimpio
Contact
[email protected]
Gabrail Cancer Center Research
Canton Ohio, 44718, United States More Info
Gabrail Nashat, M.D
Contact
[email protected]
Thompson Cancer Survival Center (TCSC ) - Downtown
Knoxville Tennessee, 37916, United States More Info
David Chism
Contact
[email protected]
University of Tennessee Medical Center
Knoxville Tennessee, 37920, United States More Info
Neil Faulkner, MD
Contact
[email protected]
University of Virginia Medical Center
Charlottesville Virginia, 22903, United States More Info
Richard Hall
Contact
[email protected]
Bon Secours Cancer Institute Richmond
Midlothian Virginia, 23114, United States More Info
William Irvin
Contact
[email protected]
Macquarie University Health Science Center (MQ Health)
Macquarie Park New South Wales, 2109, Australia More Info
John Park
Contact
[email protected]
Southern Medical Day Care Centre
Wollongong New South Wales, NSW 2, Australia More Info
Daniel Paul Brungs, MD
Contact
[email protected]
Ballarat Regional Integrated Cancer Centre (BRICC)
Ballarat Victoria, 3350, Australia More Info
Wasek Faisal
Contact
[email protected]
Bendigo Hospital
Bendigo Victoria, 3550, Australia More Info
Say Ng
Contact
[email protected]
LTD Cancer Center of Adjara
Batumi Adjaria, 6000, Georgia More Info
Tamta Makharadze
Contact
[email protected]
Israeli Georgian medical research clinic Helsicore
Tbilisi , 0112, Georgia More Info
Ekaterine Arkania
Contact
[email protected]
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi , 0159, Georgia More Info
Mamia Khutashvilli
Contact
[email protected]
TIM - Tbilisi Institute of Medicine
Tbilisi , 0160, Georgia More Info
Mariam Zhvania
Contact
[email protected]
Research Institute of Clinical Medicine
Tbilisi , 112, Georgia More Info
Tamar Melkadze
Contact
[email protected]
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi , 144, Georgia More Info
Miranda Gogishvilli
Contact
[email protected]
The Institute of Clinical Oncology
Tbilisi , 159, Georgia More Info
Vladimir Kuchava
Contact
[email protected]
JSC Evex Hospitals- Caraps Medline
Tbilisi , 179, Georgia More Info
Nana Chikhladze
Contact
[email protected]
Chungbuk National University Hospital
Cheongju-si Chungbuk, 28644, Korea, Republic of More Info
Ki Hyeong Lee
Contact
[email protected]
Ajou University Hospital
Suwon Gyeonggi, 16499, Korea, Republic of More Info
Hyun Woo Lee
Contact
[email protected]
Jeonbuk National University Hospital
Jeonju Jeollabuk-do, 54907, Korea, Republic of More Info
Eun-Kee Song
Contact
[email protected]
Chungnam National University Hospital
Daejeon , 35015, Korea, Republic of More Info
Hyewon Ryu, MD
Contact
[email protected]
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of More Info
Hee Kyung Ahn
Contact
[email protected]
Inha University Hospital
Incheon , 22332, Korea, Republic of More Info
Jeong Seon Ryu
Contact
[email protected]
Korea University Guro Hospital
Seoul , 8308, Korea, Republic of More Info
Sung Yong Lee
Contact
[email protected]
Ulsan University Hospital
Ulsan , 44033, Korea, Republic of More Info
Young-Joo Min
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

850

Study ID:

NCT05785767

Recruitment Status:

Recruiting

Sponsor:


Regeneron Pharmaceuticals

How clear is this clinincal trial information?

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