Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer
NCT ID: NCT04262856
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
151 participants
INTERVENTIONAL
2020-05-28
2025-07-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1 (zimberelimab monotherapy)
Participants will receive zimberelimab as an intravenous (IV) infusion.
Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Arm 2 (domvanalimab and zimberelimab combination therapy)
Participants will receive domvanalimab IV in combination with zimberelimab IV infusion.
Domvanalimab
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy)
Participants will receive oral etrumadenant in combination with domvanalimab IV and zimberelimab IV infusion
Domvanalimab
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist
Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Interventions
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Domvanalimab
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist
Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed, treatment naive, metastatic squamous or non-squamous NSCLC with documented high PD-L1 expression, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Must have at least 1 measurable lesion per RECIST v1.1
* Adequate organ and marrow function
Exclusion Criteria
* Any gastrointestinal condition that would preclude the use of oral medications (eg, difficulty swallowing, nausea, vomiting, or malabsorption)
* History of trauma or major surgery within 28 days prior to the first dose of IMP
* Concurrent medical condition requiring the use of supra-physiologic doses of corticosteroids (\> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications
* Positive test results for Hepatitis B surface antigen, Hepatitis C virus antibody with presence of Hepatitis C qualitative RNA or human immunodeficiency virus (HIV-1 and/or HIV-2) antibody at screening
* Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
* Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Arcus Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Arcus Biosciences, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, 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 - 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
Ochsner Clinic Foundation
New Orleans, Louisiana, 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
Sarah Cannon Research Institute
Nashville, Tennessee, United States
The Center For Cancer And Blood Disorders (Texas Cancer Care)
Fort Worth, Texas, United States
Millennium Oncology
Houston, 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, , Australia
Coffs Harbour Health Campus
Coffs Harbour, , Australia
Adelaide Cancer Centre
Elizabeth Vale, , Australia
Shoalhaven Cancer Care Centre
Nowra, , Australia
McGill University Health Centre (MUHC) - The Montreal Children's Hospital (MCH)
Montreal, , Canada
Hong Kong United Oncology Centre
Hong Kong, , Hong Kong
Queen Elizabeth Hospital (Hong Kong)
Hong Kong, , Hong Kong
Curie Oncology
Singapore, , Singapore
Kosin University Gospel Hospital
Busan, , South Korea
Chungbuk National University Hospital (CBNUH)
Cheongju-si, , South Korea
Chonnam University Hospital
Hwasun, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Asan Medical Center
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
St Vincent Hospital of the Catholic University of Korea
Suwon, , South Korea
Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, , South Korea
Taipei Medical University - Shuang Ho Hospital
New Taipei City, , Taiwan
Chi Mei Hospital
Tainan City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital at Linkou
Taoyuan District, , Taiwan
Countries
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Related Links
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ARC-7 - Public website
Other Identifiers
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ARC-7 (AB154CSP0002)
Identifier Type: -
Identifier Source: org_study_id
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