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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 : April 15, 2022
Sponsor:
Information provided by (Responsible Party):
Arcus Biosciences, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
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

Detailed Description:

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 Design
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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 : November 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 (zimberelimab monotherapy)
Participants will receive zimberelimab as an intravenous (IV) infusion.
 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 IV in combination with zimberelimab 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 IV and domvanalimab 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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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) ]
    DoR as assessed by RECIST v1.1

  2. Disease control rate (DCR) [ Time Frame: From the date of first occurrence 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

  3. Overall Survival (OS) [ Time Frame: From randomization to death from any cause (up to approximately 5 years) ]
    OS as assessed at the time of PFS

  4. Number of Participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From Screening until up to 30 days after the last dose (approximately 5 years) ]
    The number and percentage of participants that experience TEAE

  5. 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) ]
    Serum concentration of zimberelimab as determined by validated assays

  6. 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) ]
    Serum concentration of domvanalimab as determined by validated assays

  7. 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) ]
    Serum concentration of etrumadenant as determined by validated assays

  8. 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

  9. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female participants; age ≥ 18 years
  • Histologically confirmed, treatment naïve, 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:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Medical Director +1-510-462-3330 clinicalTrialInquiry@arcusbio.com

Locations
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Sponsors and Collaborators
Arcus Biosciences, Inc.
Investigators
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Study Director: Medical Director Arcus Biosciences, Inc.
More Information
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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: April 15, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arcus Biosciences, Inc.:
Non Small Cell Lung Cancer
Lung Cancer
NSCLC
Additional relevant MeSH terms:
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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