Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer (ARC-7)
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ClinicalTrials.gov Identifier: NCT04262856 |
Recruitment Status :
Recruiting
First Posted : February 10, 2020
Last Update Posted : January 20, 2021
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Condition or disease | Intervention/treatment | Phase |
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Non Small Cell Lung Cancer Nonsquamous Non Small Cell Lung Cancer Squamous Non Small Cell Lung Cancer Lung Cancer | Drug: Zimberelimab Drug: Domvanalimab Drug: Etrumadenant | Phase 2 |
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).
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | May 28, 2020 |
Estimated Primary Completion Date : | March 31, 2022 |
Estimated Study Completion Date : | June 23, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1 (zimberelimab monotherapy)
Participants will receive zimberelimab monotherapy by IV infusion.
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Drug: Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Other Name: AB122 |
Experimental: Arm 2 (domvanalimab and zimberelimab combination therapy)
Participants will receive domvanalimab in combination with zimberelimab by IV infusion.
|
Drug: Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Other Name: AB122 Drug: Domvanalimab Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
Other Name: AB154 |
Experimental: Arm 3 (domvanalimab, zimberelimab, and etrumadenant combination therapy)
Participants will receive oral etrumadenant in combination with zimberelimab and domvanalimab by IV infusion
|
Drug: Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Other Name: AB122 Drug: Domvanalimab Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
Other Name: AB154 Drug: Etrumadenant Etrumadenant is an A2aR and A2bR antagonist
Other Name: AB928 |
- Objective response rate (ORR) [ Time Frame: From randomization until death from any cause (up to approximately 3-5 years) ]ORR as assessed by RECIST v1.1
- Progression-free survival (PFS) [ Time Frame: From randomization until death from any cause (up to approximately 3-5 years) ]PFS as assessed by RECIST v1.1
- Duration of response (DoR) [ Time Frame: From the date of first occurence 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) ]DoR as assessed by RECIST v1.1
- Disease control rate (DCR) [ Time Frame: From the date of first occurence of a documented objective response to first documentation of disease progression on death from any cause, whichever occurs first (up to approximately 3-5 years) ]DCR as assessed by RECIST v1.1
- Adverse Events [ Time Frame: From Screening until up to 100 days after the last dose (approximately 2 years) ]The number and percentage of participants that experience an adverse event (AE)
- Pharmacodynamics 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). ]Plasma concentration of zimberelimab
- Pharmacodynamics 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). ]Plasma concentration of domvanalimab
- Pharmacodynamics 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). ]Plasma concentration of etrumadenant
- 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). ]Percentage of participants who develop treatment-emergent anti-drug antibodies to zimberelimab
- 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). ]Percentage of participants who develop treatment-emergent anti-drug antibodies to domvanalimab

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female participants; age ≥ 18 years
- Histologically confirmed squamous or nonsquamous, PD-L1 positive, NSCLC that is locally advanced or metastatic without sensitizing epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation expression
- 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:
- Use of any live vaccines against infectious diseases within 28 days of first dose
- 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 or Hepatitis C qualitative RNA or human immunodeficiency virus-1 (HIV-1) antibody
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04262856
Contact: Medical Director | 510-694-6220 | clinicaltrialinquiry@arcusbio.com |

Study Director: | Medical Director | Arcus Biosciences, Inc. |
Responsible Party: | Arcus Biosciences, Inc. |
ClinicalTrials.gov Identifier: | NCT04262856 |
Other Study ID Numbers: |
AB154CSP0002 |
First Posted: | February 10, 2020 Key Record Dates |
Last Update Posted: | January 20, 2021 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Non Small Cell Lung Cancer Lung Cancer NSCLC |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |