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Completed

NCT Number: NCT04262856

Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive 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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nonsquamous Non Small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Non Small Cell Lung Cancer Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Border Medical Oncology, Albury, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Domvanalimab

Drug

Domvanalimab is a humanized monoclonal antibody targeting human TIGIT

Other names: AB154

Etrumadenant

Drug

Etrumadenant is an A2aR and A2bR antagonist

Other names: AB928

Zimberelimab

Drug

Zimberelimab is a fully human anti-PD-1 monoclonal antibody

Other names: AB122

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  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 or 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 90-100 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

Sponsors and collaborators

Lead sponsor

Arcus Biosciences, Inc.

Industry

Collaborators

  • Gilead Sciences

Registry information

Official study 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

Acronym: ARC-7

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2020
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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