Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
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 ID: NCT05785767
Conditions
Study Description
Brief 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
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Yuma Regional Medical Center, Yuma, Arizona, United States
Desert Hematology Oncology Medical Group, Inc., Rancho Mirage, California, United States
Emad Ibrahim, MD, Inc., Redlands, California, United States
Clerrmont Oncology Center, Clermont, Florida, United States
Miami Veterans Administration HealthCare System, Miami, Florida, United States
Mid Florida Hematology and Oncology Center, Orange City, Florida, United States
Pinellas Hematology and Oncology, Saint Petersburg, Florida, United States
Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States
Hattiesburg Clinic, Hattiesburg, Mississippi, United States
Capital Health Medical Center, Pennington, New Jersey, United States
New Mexico Cancer Care Alliance/ University of New Mexico, Albuquerque, New Mexico, United States
New York Cancer and Blood Specialists, Port Jefferson Station, New York, United States
Clinical Research Alliance, Inc., Westbury, New York, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
Thompson Cancer Survival Center (TCSC ) - Downtown, Knoxville, Tennessee, United States
University of Tennessee Medical Center, Knoxville, Tennessee, United States
University of Virginia Medical Center, Charlottesville, Virginia, United States
Bon Secours Cancer Institute Richmond, Midlothian, Virginia, United States
Macquarie University Health Science Center (MQ Health), Macquarie Park, New South Wales, Australia
Riverina Cancer Care Centre (RCCC), Wagga Wagga, New South Wales, Australia
Southern Medical Day Care Centre, Wollongong, New South Wales, Australia
Ballarat Regional Integrated Cancer Centre (BRICC), Ballarat, Victoria, Australia
Bendigo Hospital, Bendigo, Victoria, Australia
British Columbia Cancer Center- Kelowna, Kelowna, British Columbia, Canada
LTD Cancer Center of Adjara, Batumi, Adjaria, Georgia
Israeli Georgian medical research clinic Helsicore, Tbilisi, , Georgia
JSC K. Eristavi National Center of Experimental and Clinical Surgery, Tbilisi, , Georgia
TIM - Tbilisi Institute of Medicine, Tbilisi, , Georgia
Research Institute of Clinical Medicine, Tbilisi, , Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Tbilisi, , Georgia
The Institute of Clinical Oncology, Tbilisi, , Georgia
JSC Evex Hospitals- Caraps Medline, Tbilisi, , Georgia
Shaare Zedek Medical Center, Jerusalem, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Assuta Medical Centers, Tel Aviv, , Israel
Chungbuk National University Hospital, Cheongju-si, Chungbuk, Korea, Republic of
Ajou University Hospital, Suwon, Gyeonggi, Korea, Republic of
Jeonbuk National University Hospital, Jeonju, Jeollabuk-do, Korea, Republic of
Chungnam National University Hospital, Daejeon, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Inha University Hospital, Incheon, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Ulsan University Hospital, Ulsan, , Korea, Republic of
Hospital Sultan Ismail, Johor Bahru, Johor, Malaysia
Hospital Tengku Ampuan Afzan (HTTA), Kuantan, Pahang, Malaysia
National Cancer Institute, Putrajaya, Wilayah Persekutuan, Malaysia
Hospital Kuala Lumpur, Kuala Lumpur, WP, Malaysia
Hospital Pulau Pinang, Pulau Pinang, , Malaysia
Gulhane Research and Training Hospital, Ankara, , Turkey
Memorial Ankara Hospital, Ankara, , Turkey
Contact Details
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR
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