Study Evaluating Effectiveness and Safety of Zimberelimab and Domvanalimab in Lung Cancer (ARC-10)

April 29, 2026 updated by: Arcus Biosciences, Inc.

Official Title: A Phase 2 Study to Evaluate Zimberelimab (AB122) Combined With AB154 in Front-Line, PD-L1-High, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This is a phase 2 study to evaluate zimberelimab (AB122) combined with domvanalimab (AB154) in front-line, PD-L1-high, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
  • Malaysia
      • Johor Bahru, Malaysia
        • Research Site
      • Kuala Lumpur, Malaysia
        • Research Site
      • Kuantan, Malaysia
        • Research Site
      • Kuching, Malaysia
        • Research Site
      • Pulau Pinang, Malaysia
        • Research Site
      • Putrajaya, Malaysia
        • Research Site
  • Philippines
      • Davao City, Philippines
        • Research Site
      • Manila, Philippines
        • Research Site
  • South Africa
      • George, South Africa
        • Research Site
      • Johannesburg, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
  • South Korea
      • Daegu, South Korea
        • Research Site
      • Incheon, South Korea
        • Research Site
      • Jinju, South Korea
        • Research Site
      • Seoul, South Korea
        • Research Site
      • Suwon, South Korea
        • Research Site
  • Taiwan
      • Taichung, Taiwan
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • Research Site
      • Changwat Sara Buri, Thailand
        • Research Site
      • Chanthaburi, Thailand
        • Research Site
      • Chiang Mai, Thailand
        • Research Site
      • Khon Kaen, Thailand
        • Research Site
      • Lampang, Thailand
        • Research Site
      • Nakhon Nayok, Thailand
        • Research Site
      • Nakhon Ratchasima, Thailand
        • Research Site
      • Phitsanulok, Thailand
        • Research Site
      • Songkhla, Thailand
        • Research Site
      • Ubon Ratchathani, Thailand
        • Research Site
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye)
        • Research Site
      • Ankara, Turkey (Türkiye)
        • Research Site
      • Edirne, Turkey (Türkiye)
        • Research Site
      • Istanbul, Turkey (Türkiye)
        • Research Site
      • Kocaeli, Turkey (Türkiye)
        • Research Site
  • United States
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Research Site
    • Texas
      • Kingwood, Texas, United States, 77339
        • Research Site
    • Virginia
      • Blacksburg, Virginia, United States, 24014
        • Research Site
  • Vietnam
      • Hanoi, Vietnam
        • Research Site
      • Huế, Vietnam
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Histologically confirmed, treatment naïve, locally advanced or metastatic (stage IIIB IV per AJCC version 8), squamous or non-squamous NSCLC with documented high PD L1 expression (TC ≥ 50%) as determined by the VENTANA SP263 IHC assay, as assessed by central laboratories).
  • 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

  • If a participant has brain or meningeal metastases, the participant must meet the following criteria:

    1. Have no evidence of progression by neurologic symptoms or signs for at least 4 weeks prior to the first dose.
    2. Participants with previously treated brain metastases may participate provided they have stable central nervous system (CNS) disease for at least 4 weeks prior to enrollment. Stable CNS disease is defined as resolution of all neurologic symptoms to baseline, having no evidence of new or enlarging brain metastases, and not requiring use of corticosteroids for CNS disease for at least 14 days prior to the start of study treatment. Participants who have had brain metastases resected or have received whole brain radiotherapy ending at least 4 weeks (or stereotactic radiotherapy ending at least 2 weeks) prior to initiation of study treatment are permitted.
    3. Carcinomatous meningitis is excluded regardless of clinical stability.

Key Exclusion Criteria:

  • Presence of any tumor genomic aberration or driver mutation for which a targeted therapy is approved by local health authority and available
  • Use of any live vaccines against infectious diseases within 28 days of first dose
  • 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
  • Prior treatment with any anti-PD-1, anti-PD-L1 or any other antibody targeting an immune checkpoint.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A - Study Part 1 (Platinum-based Chemotherapy)
Participants will receive carboplatin, pemetrexed, and paclitaxel by intravenous (IV) infusion.
Drug: Carboplatin
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
Drug: Pemetrexed
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
Drug: Paclitaxel
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
Experimental: Arm B - Study Part 1 (Zimberelimab Monotherapy)
Participants will receive zimberelimab monotherapy by IV infusion.
Drug: Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Other Names:
  • AB122
Experimental: Arm D - Study Part 2 (Domvanalimab + 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 Names:
  • AB122
Drug: Domvanalimab
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
Other Names:
  • AB154
Experimental: Arm C - Study Part 1 (Domvanalimab + Zimberelimab Combination Therapy)
Participants will receive zimberelimab in combination with AB154 by IV infusion.
Drug: Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Other Names:
  • AB122
Drug: Domvanalimab
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
Other Names:
  • AB154
Active Comparator: Arm E - Study Part 2 (Pembrolizumab)
Participants will receive pembrolizumab by IV infusion.
Drug: Pembrolizumab
Pembrolizumab is a humanized Immunoglobulin G4 monoclonal antibody targeting the PD-1 receptor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free Survival (PFS)
Time Frame: From randomization until death from any cause (up to 7 years)
From randomization until death from any cause (up to 7 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: From randomization until death from any cause (up to 7 years)
From randomization until death from any cause (up to 7 years)
Confirmed Overall Response Rate (ORR)
Time Frame: From randomization until death from any cause (up to 7 years)
From randomization until death from any cause (up to 7 years)
Number of Participants With treatment-emergent adverse events
Time Frame: From randomization until death from any cause (up to 7 years)
From randomization until death from any cause (up to 7 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arcus Biosciences, Inc.

Collaborators

Gilead Sciences

Investigators

  • Study Director: Medical Director, Arcus Biosciences, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2021

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARC-10
  • 2020-003562-39 (EudraCT Number)
  • PHRR210222-003371 (Other Identifier: Philippine Health Research Registry)
  • 2022-503071-28-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

For more information, please visit our website.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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