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)
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%
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Arizona Clinical Research Center — Tucson, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (106 Sites)
Showing the first 25 of 106 sites.
- Arizona Clinical Research Center — Tucson, Arizona
- Yuma Regional Medical Center — Yuma, Arizona
- Emad Ibrahim, MD, Inc. — Redlands, California
- Eastern CT Hematology and Oncology Associates — Norwich, Connecticut
- Clermont Oncology Center — Clermont, Florida
- Miami Veterans Administration HealthCare System — Miami, Florida
- Mid Florida Hematology and Oncology Center — Orange City, Florida
- Pinellas Hematology and Oncology — St. Petersburg, Florida
- Tallahassee Memorial Healthcare — Tallahassee, Florida
- Moffitt Cancer Center — Tampa, Florida
- University of Illinois — Chicago, Illinois
- Mary Bird Perkins Cancer Center — Baton Rouge, Louisiana
- Hattiesburg Clinic — Hattiesburg, Mississippi
- Mercy South — St Louis, Missouri
- St. Vincent Healthcare — Billings, Montana
- New Mexico Cancer Care Alliance — Albuquerque, New Mexico
- Clinical Research Alliance Inc — Westbury, New York
- Gabrail Cancer Center Research — Canton, Ohio
- University of Tennessee Medical Center — Knoxville, Tennessee
- Renovatio Clinical — El Paso, Texas
- MD Anderson Cancer Center — Houston, Texas
- University of Virginia Medical Center — Charlottesville, Virginia
- Bon Secours Cancer Institute Richmond — Midlothian, Virginia
- Macquarie University Health Science Center (MQ Health) — Macquarie Park, New South Wales
- Riverina Cancer Care Centre (RCCC) — Wagga Wagga, New South Wales
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Advanced Non-Small Cell Lung Cancer
- A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1) — Los Angeles, California
- Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Patients — Tarrytown, New York
- The Study of NC318 Alone or in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer — New Haven, Connecticut
- Study With Various Immunotherapy Treatments in Participants With Lung Cancer — Birmingham, Alabama
- Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer — Bullhead City, Arizona
Explore by condition: All Advanced Non-Small Cell Lung Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.