Spots Global Cancer Trial Database for Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer
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Trial Identification
Brief Title: Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer
Official Title: A Phase 2 Study to Evaluate the Safety and Efficacy of AB122 Monotherapy, AB154 in Combination With AB122, and AB154 in Combination With AB122 and AB928 in Front-Line, Non-Small Cell Lung Cancer
Study ID: NCT04262856
Study Description
Brief Summary: This randomized phase 2 open-label study will evaluate the safety and efficacy of zimberelimab (AB122) monotherapy, domvanalimab (AB154) in combination with zimberelimab, and domvanalimab in combination with zimberelimab and etrumadenant (AB928) in front-line, PD-L1 positive, metastatic non-small cell lung cancer.
Detailed Description: This is an open-label phase 2 study in participants with non-small cell lung cancer which will assess the safety, efficacy and tolerability of zimberelimab as monotherapy and in combination with other immunotherapeutics across multiple treatment arms. Approximately 150 participants will be randomized to 1 of 3 treatment arms: 1) zimberelimab, 2) zimberelimab + domvanalimab (anti-TIGIT antibody), 3) zimberelimab + domvanalimab + etrumadenant (dual adenosine receptor antagonist). Participants that progress on the zimberelimab monotherapy arm may cross-over to receive the third arm combination of zimberelimab + domvanalimab + etrumadenant. The primary objective of this clinical study is to evaluate the efficacy of each combination therapy by assessing: 1) objective response rate (ORR) of participants with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and 2) progression free survival (PFS).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Pacific Cancer Medical Center, Inc, Anaheim, California, United States
Innovative Clinical Research Institute (ICRI), Whittier, California, United States
Florida Cancer Specialists, Englewood, Florida, United States
Florida Cancer Specialists, Gainesville, Florida, United States
Florida Cancer Specialists, Saint Petersburg, Florida, United States
Florida Cancer Specialists - Panhandle, Tallahassee, Florida, United States
Florida Cancer Specialists - East, West Palm Beach, Florida, United States
Baptist Health Lexington, Lexington, Kentucky, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Baptist Hospital East, Louisville, Kentucky, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
American Oncology Partners of Maryland, PA, Bethesda, Maryland, United States
Detroit Clinical Research Center, PC, Farmington Hills, Michigan, United States
Hattiesburg Clinic, Hattiesburg, Mississippi, United States
Comprehensive Cancer Centers Of Nevada, Las Vegas, Nevada, United States
The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion, Ridgewood, New Jersey, United States
Clinical Research Alliance, Lake Success, New York, United States
Northwell Health Cancer Institute, Lake Success, New York, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
Allegheny General Hospital (AGH)-Alleghney Singer Research Institute, Pittsburgh, Pennsylvania, United States
Prisma Health-Upstate, Greenville, South Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
The Center For Cancer And Blood Disorders (Texas Cancer Care), Fort Worth, Texas, United States
Dr.John R Waldron, MD Off of, Kingwood, Texas, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
Tyler Hematology-Oncology, P.A., Tyler, Texas, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care, Blacksburg, Virginia, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Border Medical Oncology, Albury, New South Wales, Australia
Coffs Harbour Health Campus, Coffs Harbour, New South Wales, Australia
Shoalhaven Cancer Care Centre, Nowra, New South Wales, Australia
Tweed Hospital, Tweed Heads, New South Wales, Australia
Adelaide Cancer Centre, Elizabeth Vale, South Australia, Australia
Brampton Civic Hospital (Bch), William Osler Health Centre, Brampton, , Canada
McGill University Health Centre (MUHC) - The Montreal Children's Hospital (MCH), Montréal, , Canada
Centre Integre de Sante et de Services Sociaux des Laurentides Hopital regional de Saint-Jerome, Saint Jerome, , Canada
Hong Kong United Oncology Centre, Hong Kong, , Hong Kong
Humanity and Health Research Center, Hong Kong, , Hong Kong
Princess Margaret Hospital, Hong Kong, , Hong Kong
Queen Elizabeth Hospital (Hong Kong), Hong Kong, , Hong Kong
Kosin University Gospel Hospital, Busan, , Korea, Republic of
Chonnam University Hospital, Hwasun, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Chonbuk National University Hospital, Jeonju, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Kangbuk Samsung Hospital, Seoul, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
St Vincent Hospital of the Catholic University of Korea, Suwon-si, , Korea, Republic of
Catholic University of Korea, Uijeongbu St. Mary's Hospital, Uijeongbu, , Korea, Republic of
Raffles Hospital, Singapore, , Singapore
Oncocare Cancer Centre, Singapore, , Singapore
Curie Oncology, Singapore, , Singapore
Chang Gung Memorial Hospital, Kaohsiung Branch, Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
Taipei Medical University - Shuang Ho Hospital, New Taipei, , Taiwan
Chung Shan Medical University Hospital, Taichung City, , Taiwan
Chi Mei Hospital, Tainan City, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Tri-Service General Hospital, Taipei City, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Medical University Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital at Linkou, Taoyuan, , Taiwan
Contact Details
Name: Medical Director
Affiliation: Arcus Biosciences, Inc.
Role: STUDY_DIRECTOR
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