Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer
ARC-7
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
1 other identifier
interventional
151
7 countries
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2020
Longer than P75 for phase_2
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2020
CompletedFirst Posted
Study publicly available on registry
February 10, 2020
CompletedStudy Start
First participant enrolled
May 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 9, 2025
CompletedAugust 26, 2025
August 1, 2024
5 years
January 23, 2020
August 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Objective response rate (ORR)
ORR as assessed by RECIST v1.1
From randomization until the first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
Progression-free survival (PFS)
PFS as assessed by RECIST v1.1
From randomization until the first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
Secondary Outcomes (9)
Duration of response (DoR)
From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
Disease control rate (DCR)
From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
Overall Survival (OS)
From randomization to death from any cause (up to approximately 5 years)
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
From Screening until up to 90-100 days after the last dose (approximately 5 years)
Pharmacokinetics of zimberelimab
Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, 60 and 100 days post last dose (in total, an average of 2 years)
- +4 more secondary outcomes
Study Arms (3)
Arm 1 (zimberelimab monotherapy)
EXPERIMENTALParticipants will receive zimberelimab as an intravenous (IV) infusion.
Arm 2 (domvanalimab and zimberelimab combination therapy)
EXPERIMENTALParticipants will receive domvanalimab IV in combination with zimberelimab IV infusion.
Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy)
EXPERIMENTALParticipants will receive oral etrumadenant in combination with domvanalimab IV and zimberelimab IV infusion
Interventions
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
Etrumadenant is an A2aR and A2bR antagonist
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Eligibility Criteria
You may qualify if:
- Male or female participants; age ≥ 18 years
- 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
You may not qualify if:
- Use of any live vaccines against infectious diseases within 28 days of first dose of investigational medicinal products (IMPs)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arcus Biosciences, Inc.lead
- Gilead Sciencescollaborator
Study Sites (44)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Innovative Clinical Research Institute (ICRI)
Whittier, California, 90603, United States
Florida Cancer Specialists
Englewood, Florida, 34223, United States
Florida Cancer Specialists
Gainesville, Florida, 32605, United States
Florida Cancer Specialists - Panhandle
Tallahassee, Florida, 32308, United States
Florida Cancer Specialists - East
West Palm Beach, Florida, 33401, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion
Ridgewood, New Jersey, 07450, United States
Clinical Research Alliance
Lake Success, New York, 11042, United States
Northwell Health Cancer Institute
Lake Success, New York, 11042, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
Allegheny General Hospital (AGH)-Alleghney Singer Research Institute
Pittsburgh, Pennsylvania, 15224, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
The Center For Cancer And Blood Disorders (Texas Cancer Care)
Fort Worth, Texas, 76104, United States
Millennium Oncology
Houston, Texas, 77339, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, 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, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital at Linkou
Taoyuan District, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Arcus Biosciences, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2020
First Posted
February 10, 2020
Study Start
May 28, 2020
Primary Completion
June 5, 2025
Study Completion
July 9, 2025
Last Updated
August 26, 2025
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.