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
Public ClinicalTrials.gov record NCT05800015. 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), Cemiplimab (Anti-PD-1 Antibody), and Chemotherapy Versus Cemiplimab and Chemotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Irrespective of PD-L1 Expression Levels
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT05800015
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 160 participants
Conditions and interventions
Conditions
Interventions
- fianlimab Drug
- cemiplimab Drug
- Pemetrexed Drug
- Paclitaxel Drug
- Carboplatin Drug
- Cisplatin 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
- Aug 7, 2023
- Primary completion
- Jan 15, 2030
- Completion
- Dec 22, 2031
- Last update posted
- Jul 14, 2026
2023 – 2031
United States locations
- U.S. sites
- 29
- U.S. states
- 14
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Clinical Research Center | Tucson | Arizona | 85715 | — |
| Yuma Regional Medical Center | Yuma | Arizona | 85364 | — |
| The Oncology Institute of Hope & Innovation | Cerritos | California | 90703 | — |
| Crosson Cancer Institute | Fullerton | California | 92835 | — |
| St. Joseph Hospital Orange | Orange | California | 92868 | — |
| Desert Hematology Oncology Medical Group Incorporated | Rancho Mirage | California | 92270 | — |
| Emad Ibrahim, MD, Inc. | Redlands | California | 92373 | — |
| PIH Health Hospital | Whittier | California | 90602 | — |
| Rocky Mountain Regional VA Medical Center | Aurora | Colorado | 80045 | — |
| Yale Cancer Center | New Haven | Connecticut | 06519 | — |
| Clermont Oncology Center | Clermont | Florida | 34711 | — |
| Miami Veterans Administration HealthCare System | Miami | Florida | 33125 | — |
| Mid Florida Hematology and Oncology Center | Orange City | Florida | 32763 | — |
| Tallahassee Memorial Healthcare | Tallahassee | Florida | 32308 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| Northwest Oncology and Hematology | Rolling Meadows | Illinois | 60008 | — |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | 70809 | — |
| Hattiesburg Clinic | Hattiesburg | Mississippi | 39401 | — |
| Capital Health Hopewell Medical Center | Pennington | New Jersey | 08534 | — |
| New Mexico Cancer Care Alliance | Albuquerque | New Mexico | 87102 | — |
| NYU Langone Health Perlmutter Cancer Center | New York | New York | 10016 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| Clinical Research Alliance Inc | Westbury | New York | 11590 | — |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | — |
| Thompson Cancer Survival Center (TCSC ) - Downtown | Knoxville | Tennessee | 37916 | — |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | — |
| 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 47 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05800015, 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 14, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05800015 live on ClinicalTrials.gov.