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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 · View on ClinicalTrials.gov ↗
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG fianlimab
- DRUG cemiplimab
Study Locations (20)
Florida
- Clermont Oncology Center — Clermont
- Miami Veterans Administration HealthCare System — Miami
- Mid Florida Hematology and Oncology Center — Orange City
- Pinellas Hematology and Oncology — St. Petersburg
- Tallahassee Memorial Healthcare — Tallahassee
- Moffitt Cancer Center — Tampa
Arizona
- Arizona Clinical Research Center — Tucson
- Yuma Regional Medical Center — Yuma
California
- Emad Ibrahim, MD, Inc. — Redlands
Connecticut
- Eastern CT Hematology and Oncology Associates — Norwich
Illinois
- University of Illinois — Chicago
Louisiana
- Mary Bird Perkins Cancer Center — Baton Rouge
Mississippi
- Hattiesburg Clinic — Hattiesburg
Missouri
- Mercy South — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 850 participants |
| Start Date | 2023-06-30 |
| Est. Completion | 2032-02-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05785767
The ClinicalTrials.gov registry entry for NCT05785767 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 850 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Advanced Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05785767 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05785767 about?
NCT05785767 is a clinical study titled "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)". 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...
What is the current status of trial NCT05785767?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 850 participants. The study started on 2023-06-30. Estimated completion is 2032-02-05.
What conditions does trial NCT05785767 study?
This clinical trial studies the following conditions: Advanced Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05785767?
The interventions under investigation include: Placebo (DRUG), fianlimab (DRUG), cemiplimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05785767?
This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05785767 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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