Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
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
Study ID: NCT05800015
Conditions
Study Description
Brief Summary: 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
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Yuma Regional Medical Center, Yuma, Arizona, United States
Innovative Clinical Research Institute, Cerritos, California, United States
St. Joseph Hospital Orange, Orange, California, United States
Desert Hematology Oncology Medical Group, Inc., Rancho Mirage, California, United States
Emad Ibrahim, MD, Inc., Redlands, California, United States
PIH Health Hospital, Whittier, California, United States
Clermont Oncology Center, Clermont, Florida, United States
Miami Veterans Administration HealthCare Systen, Miami, Florida, United States
Mid Florida Hematology and Oncology Center, Orange City, Florida, United States
Tallahassee Memorial Healthcare, Tallahassee, Florida, United States
Northwest Oncology and Hematology, Rolling Meadows, Illinois, United States
Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States
Hattisburg Clinic, Hattiesburg, Mississippi, United States
Capital Health Hopewell Medical Center, Pennington, New Jersey, United States
New Mexico Cancer Care Alliance, Albuquerque, New Mexico, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Clinical Research Alliance Inc., Westbury, New York, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
West Cancer Center, Germantown, Tennessee, 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
Southern Medical Day Care Centre, Wollongong, New South Wales, Australia
Ballarat Regional Integrated Cancer Centre (BRICC), Ballarat, Victoria, Australia
Bendigo Hospital, Bendigo, Victoria, Australia
St Vincents Hospital, Fitzroy, Victoria, Australia
St John of God Murdoch Hospital, Murdoch, Western Australia, 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
LTD New Hospitals, Tbilisi, , Georgia
JSC K. Eristavi National Center of Experimental and Clinical Surgery, Tbilisi, , Georgia
LTD Archangel St. Michael Multiprofile Clinical Hospital, Tbilisi, , Georgia
TIM- Tbilisi Intitute 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
Sheba Medical Center, Ramat Gan, Hamerkaz, Israel
Assuta Medical Centers, Tel Aviv, , Israel
Chungbuk National University Hospital, Cheongju-si, Chungbuk, Korea, Republic of
CHA Bundang Medical Center, CHA University, Seongnam-si, Gyeonggi Do, Korea, Republic of
Ajou University Hospital, Suwon, Gyeonggi, Korea, Republic of
Jeonbuk National University Hospital, Jeonju, Jeollabuk-do, Korea, Republic of
Asan Medical Center, Seoul, Seoul Teugbyeolsi, 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
Mount Miriam Cancer Hospital, Tanjung Bungah, Penang, Malaysia
Sarawak General Hospital, Kuching, Sarawak, Malaysia
National Cancer Institute, Putrajaya, Wilayah Persekutuan, Malaysia
Hospital Pulau Pinang, Pulau Pinang, , Malaysia
Contact Details
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR
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