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Study Comparing the Combination Domvanalimab and Zimberelimab With Pembrolizumab in Untreated Locally Advanced or Metastatic PD-L1-High Non-Small Cell Lung Cancer (ARC-10)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04736173
Recruitment Status : Active, not recruiting
First Posted : February 3, 2021
Last Update Posted : March 15, 2024
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Arcus Biosciences, Inc.

Study Description
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Brief Summary:
This is a phase 3 study to evaluate zimberelimab (AB122) combined with domvanalimab (AB154) compared to pembrolizumab in front-line, PD-L1-high, locally advanced or metastatic NSCLC.

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: Domvanalimab Drug: Zimberelimab Drug: Carboplatin Drug: Paclitaxel Drug: Pemetrexed Drug: Pembrolizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Study to Evaluate Zimberelimab (AB122) Combined With AB154 in Front-Line, PD-L1-High, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Actual Study Start Date : February 8, 2021
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : July 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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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: Paclitaxel
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.
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 Name: AB122
Active Comparator: Arm C - Study Part 1 (Domvanalimab + Zimberelimab Combination Therapy)
Participants will receive zimberelimab in combination with AB154 by IV infusion.
 Drug: Domvanalimab
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
Other Name: AB154

Drug: Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Other Name: AB122
Experimental: Arm D - Study Part 2 (Domvanalimab + Zimberelimab Combination Therapy)
Participants will receive domvanalimab in combination with zimberelimab by IV infusion.
 Drug: Domvanalimab
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
Other Name: AB154

Drug: Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Other Name: AB122
Experimental: 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


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From randomization until death from any cause (up to approximately 7 years) ]
    Arm D vs. Arm E


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: From randomization until death from any cause (up to approximately 7 years) ]
    Arm D vs. Arm E - PFS as assessed by RECIST v1.1 by blinded independent central review

  2. Confirmed Overall Response Rate (ORR) [ Time Frame: From randomization until death from any cause (up to approximately 7 years) ]
    Arm D vs. Arm E - ORR as assessed by RECIST v1.1 by blinded independent central review

  3. Number of Participants With treatment-emergent adverse events [ Time Frame: From randomization until death from any cause (up to approximately 7 years) ]
    Arm D vs. Arm E

  4. Time to first symptom deterioration in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score [ Time Frame: From randomization until death from any cause (up to approximately 7 years) ]
    Arm D vs. Arm E


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • 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.

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.

Other protocol defined Inclusion/Exclusion criteria may apply.

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): NCT04736173


Locations
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Sponsors and Collaborators
Arcus Biosciences, Inc.
Gilead Sciences
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: NCT04736173    
Other Study ID Numbers: ARC-10
2020-003562-39 ( EudraCT Number )
PHRR210222-003371 ( Other Identifier: Philippine Health Research Registry )
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024
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.

For more information, please visit our website.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
URL: https://trials.arcusbio.com/our-transparency-policy

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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
Paclitaxel
Carboplatin
Pembrolizumab
 Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors