Non Small Cell Lung CancerPhase 2ARC-7NCT04262856
Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer
A Phase 2 study testing Domvanalimab, Etrumadenant and Zimberelimab in people with Non Small Cell Lung Cancer and Nonsquamous Non Small Cell Lung Cancer, run by Arcus Biosciences, Inc. at 44 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Nonsquamous Non Small Cell Lung Cancer, Squamous Non Small Cell Lung Cancer
- What is being tested?
- Domvanalimab, Etrumadenant and Zimberelimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 44 sitesin 7 countries
- Study dates
- 28 May 2020to 9 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
44 sites in 7 countries.
44 sites in 7 countries
United States19 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060
Florida Cancer Specialists
Englewood, Florida, 34223
Virginia Cancer Specialists
Fairfax, Virginia, 22031
The Center For Cancer And Blood Disorders (Texas Cancer Care)
Fort Worth, Texas, 76104
Florida Cancer Specialists
Gainesville, Florida, 32605
Millennium Oncology
Houston, Texas, 77339
Clinical Research Alliance
Lake Success, New York, 11042
Northwell Health Cancer Institute
Lake Success, New York, 11042
Baptist Health Lexington
Lexington, Kentucky, 40503
Norton Cancer Institute
Louisville, Kentucky, 40202
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Allegheny General Hospital (AGH)-Alleghney Singer Research Institute
Pittsburgh, Pennsylvania, 15224
The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion
Ridgewood, New Jersey, 07450
Florida Cancer Specialists - Panhandle
Tallahassee, Florida, 32308
Florida Cancer Specialists - East
West Palm Beach, Florida, 33401
Innovative Clinical Research Institute (ICRI)
Whittier, California, 90603
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
South Korea11 sites
Kosin University Gospel Hospital
Busan
Chungbuk National University Hospital (CBNUH)
Cheongju-si
Chonnam University Hospital
Hwasun
Gachon University Gil Medical Center
Incheon
Chonbuk National University Hospital
Jeonju
Seoul National University Bundang Hospital
Seongnam-si
Asan Medical Center
Seoul
Kangbuk Samsung Hospital
Seoul
Korea University Anam Hospital
Seoul
St Vincent Hospital of the Catholic University of Korea
Suwon
Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si
Taiwan6 sites
Taipei Medical University - Shuang Ho Hospital
New Taipei City
Chi Mei Hospital
Tainan
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Taipei Medical University Hospital
Taipei
Chang Gung Memorial Hospital at Linkou
Taoyuan
Australia4 sites
Border Medical Oncology
Albury
Coffs Harbour Health Campus
Coffs Harbour
Adelaide Cancer Centre
Elizabeth Vale
Shoalhaven Cancer Care Centre
Nowra
Hong Kong2 sites
Hong Kong United Oncology Centre
Hong Kong
Queen Elizabeth Hospital (Hong Kong)
Hong Kong
Canada1 site
McGill University Health Centre (MUHC) - The Montreal Children's Hospital (MCH)
Montreal
About this study
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
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.
- Conditions
- Non Small Cell Lung Cancer, Nonsquamous Non Small Cell Lung Cancer, Squamous Non Small Cell Lung Cancer, Lung Cancer
- Being tested
- Domvanalimab, Etrumadenant, Zimberelimab
- Keywords
- Non Small Cell Lung Cancer, Lung Cancer, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DomvanalimabDrug
Also called AB154
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
EtrumadenantDrug
Also called AB928
Etrumadenant is an A2aR and A2bR antagonist
ZimberelimabDrug
Also called AB122
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (zimberelimab monotherapy) | Experimental | Participants will receive zimberelimab as an intravenous (IV) infusion. Receives: Drug: Zimberelimab |
| Arm 2 (domvanalimab and zimberelimab combination therapy) | Experimental | Participants will receive domvanalimab IV in combination with zimberelimab IV infusion. Receives: Drug: Domvanalimab; Drug: Zimberelimab |
| Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy) | Experimental | Participants will receive oral etrumadenant in combination with domvanalimab IV and zimberelimab IV infusion Receives: Drug: Domvanalimab; Drug: Etrumadenant; Drug: Zimberelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR as assessed by RECIST v1.1
Measured: 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
Measured: 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)
DoR as assessed by RECIST v1.1
Measured: 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)
DCR as assessed by RECIST v1.1
Measured: 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)
OS as assessed at the time of PFS
Measured: From randomization to death from any cause (up to approximately 5 years)
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
The number and percentage of participants that experience TEAE
Measured: From Screening until up to 90-100 days after the last dose (approximately 5 years)
Pharmacokinetics of zimberelimab
Serum concentration of zimberelimab as determined by validated assays
Measured: 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)
Pharmacokinetics of domvanalimab
Serum concentration of domvanalimab as determined by validated assays
Measured: 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)
Pharmacokinetics of etrumadenant
Serum concentration of etrumadenant as determined by validated assays
Measured: 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)
Immunogenicity of zimberelimab
Percentage of participants who develop treatment-emergent anti-drug antibodies to zimberelimab
Measured: Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, and 100 days post last dose (in total, an average of 2 years).
Immunogenicity of domvanalimab
Percentage of participants who develop treatment-emergent anti-drug antibodies to domvanalimab
Measured: Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, and 100 days post last dose (in total, an average of 2 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start28 May 2020
- Primary completion9 Jul 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcus Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Arcus Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262856
- Sponsor's protocol ID
- ARC-7 (AB154CSP0002)
- Acronym
- ARC-7
- Status last verified
- Aug 2024
- First submitted
- 23 Jan 2020
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04262856
- Acronym / sponsor ID
- ARC-7 / ARC-7 (AB154CSP0002)
- Conditions
- Non Small Cell Lung Cancer, Nonsquamous Non Small Cell Lung Cancer, Squamous Non Small Cell Lung Cancer, Lung Cancer
- Keywords
- Non Small Cell Lung Cancer, Lung Cancer, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Arcus Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Study start
- 28 May 2020 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (zimberelimab monotherapy) | Experimental | Drug: ZimberelimabParticipants will receive zimberelimab as an intravenous (IV) infusion. |
| Arm 2 (domvanalimab and zimberelimab combination therapy) | Experimental | Drug: Domvanalimab, Drug: ZimberelimabParticipants will receive domvanalimab IV in combination with zimberelimab IV infusion. |
| Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy) | Experimental | Drug: Domvanalimab, Drug: Etrumadenant, Drug: ZimberelimabParticipants will receive oral etrumadenant in combination with domvanalimab IV and zimberelimab IV infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DomvanalimabAlso: AB154Domvanalimab is a humanized monoclonal antibody targeting human TIGIT | Drug | Arm 2 (domvanalimab and zimberelimab combination therapy), Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy) |
| EtrumadenantAlso: AB928Etrumadenant is an A2aR and A2bR antagonist | Drug | Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy) |
| ZimberelimabAlso: AB122Zimberelimab is a fully human anti-PD-1 monoclonal antibody | Drug | Arm 1 (zimberelimab monotherapy), Arm 2 (domvanalimab and zimberelimab combination therapy), Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy) |
Primary outcome
Objective response rate (ORR)
Time frame: From randomization until the first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
ORR as assessed by RECIST v1.1
Progression-free survival (PFS)
Time frame: From randomization until the first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
PFS as assessed by RECIST v1.1
9 secondary outcomes
Duration of response (DoR)
Time frame: 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)
Time frame: 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)
Time frame: From randomization to death from any cause (up to approximately 5 years)
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: From Screening until up to 90-100 days after the last dose (approximately 5 years)
Pharmacokinetics of zimberelimab
Time frame: 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)
Pharmacokinetics of domvanalimab
Time frame: 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)
Pharmacokinetics of etrumadenant
Time frame: 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)
Immunogenicity of zimberelimab
Time frame: Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, and 100 days post last dose (in total, an average of 2 years).
Immunogenicity of domvanalimab
Time frame: Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, and 100 days post last dose (in total, an average of 2 years).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- ARC-7 - Public websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Arcus Biosciences, Inc.
44 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Domvanalimab, Etrumadenant and Zimberelimab in people with Non Small Cell Lung Cancer and Nonsquamous Non Small Cell Lung Cancer, run by Arcus Biosciences, Inc. at 44 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, South Korea, Taiwan, Australia, Hong Kong and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: From randomization until the first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.