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%
Study identification
- NCT ID
- NCT05785767
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Lead sponsor
- Regeneron Pharmaceuticals
- Industry
- Enrollment
- 149 participants
Conditions and interventions
Conditions
Interventions
- fianlimab Drug
- cemiplimab Drug
- Placebo Drug
Drug
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 29, 2023
- Primary completion
- Sep 27, 2027
- Completion
- Sep 27, 2027
- Last update posted
- Jul 1, 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 1, 2026 · Synced Jul 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05785767 live on ClinicalTrials.gov.