A Phase 2 interventional study of Domvanalimab and Etrumadenant in Non Small Cell Lung Cancer, Nonsquamous Non Small Cell Lung Cancer and Squamous Non Small Cell Lung Cancer, sponsored by Arcus Biosciences, Inc.. Completed at 44 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Arcus Biosciences, Inc. · Phase 2, Interventional, and Treatment
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.
6,491 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,633 are open to participants now.
This study's enrollment of 151 is above the median of 62 across 5,216 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Arcus Biosciences, Inc. is the lead sponsor of 32 studies on the registry; 4 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive zimberelimab as an intravenous (IV) infusion.
Drug: Zimberelimab
Participants will receive domvanalimab IV in combination with zimberelimab IV infusion.
Drug: Domvanalimab · Drug: Zimberelimab
Participants will receive oral etrumadenant in combination with domvanalimab IV and zimberelimab IV infusion
Drug: Domvanalimab · Drug: Etrumadenant · Drug: Zimberelimab
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
Also known as: AB154
Etrumadenant is an A2aR and A2bR antagonist
Also known as: AB928
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Also known as: AB122
Objective response rate (ORR)
ORR as assessed by RECIST v1.1
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)
Progression-free survival (PFS)
PFS as assessed by RECIST v1.1
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)
Duration of response (DoR)
DoR as assessed by RECIST v1.1
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)
DCR as assessed by RECIST v1.1
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)
OS as assessed at the time of PFS
Time frame: 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
Time frame: 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
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
Serum concentration of domvanalimab as determined by validated assays
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
Serum concentration of etrumadenant as determined by validated assays
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
Percentage of participants who develop treatment-emergent anti-drug antibodies to 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
Percentage of participants who develop treatment-emergent anti-drug antibodies to 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).
Plan to share: 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.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Arcus Biosciences, Inc.