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)
Public ClinicalTrials.gov record NCT05785767. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody) in Combination With Cemiplimab (Anti-PD-1 Antibody) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50%
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT05785767
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 149 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2023 (Actual)
- Primary completion
- Sep 28, 2027 (Estimated)
- Completion
- Sep 28, 2027 (Estimated)
- Last update posted
- Jul 2, 2026
2023 – 2027
United States locations
- U.S. sites
- 23
- U.S. states
- 15
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Clinical Research Center | Tucson | Arizona | 85715 | — |
| Yuma Regional Medical Center | Yuma | Arizona | 85364 | — |
| Emad Ibrahim, MD, Inc. | Redlands | California | 92373 | — |
| Eastern CT Hematology and Oncology Associates | Norwich | Connecticut | 06360 | — |
| Clermont Oncology Center | Clermont | Florida | 34711 | — |
| Miami Veterans Administration HealthCare System | Miami | Florida | 33125 | — |
| Mid Florida Hematology and Oncology Center | Orange City | Florida | 32763 | — |
| Pinellas Hematology and Oncology | St. Petersburg | Florida | 33709 | — |
| Tallahassee Memorial Healthcare | Tallahassee | Florida | 32308 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | 70809 | — |
| Hattiesburg Clinic | Hattiesburg | Mississippi | 39401 | — |
| Mercy South | St Louis | Missouri | 63128 | — |
| St. Vincent Healthcare | Billings | Montana | 59102 | — |
| New Mexico Cancer Care Alliance | Albuquerque | New Mexico | 87102 | — |
| Clinical Research Alliance Inc | Westbury | New York | 11590 | — |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | — |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | — |
| Renovatio Clinical | El Paso | Texas | 79915 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | — |
| Bon Secours Cancer Institute Richmond | Midlothian | Virginia | 23114 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 83 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05785767, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 2, 2026 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05785767 live on ClinicalTrials.gov.