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Study to Evaluate Monotherapy Compared to Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT04736173
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Arcus Biosciences, Inc.

Brief Summary:
This Randomized Phase 3 Open-label Study will Evaluate the Efficacy of Zimberelimab (AB122) Monotherapy Compared to Standard Chemotherapy or Zimberelimab Combined with AB154 in Front-Line, PD-L1-Positive Locally Advanced or 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: Carboplatin Drug: Pemetrexed Drug: Paclitaxel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 625 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Study to Evaluate Zimberelimab (AB122) Monotherapy Compared to Standard Chemotherapy or Zimberelimab Combined With AB154 in Front-Line, PD-L1-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm A (Platinum-based Chemotherapy)
Participants receive carboplatin, pemetrexed, and paclitaxel.
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 (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 (Zimberelimab + AB154 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 Name: AB122

Drug: Domvanalimab
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
Other Name: AB154




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

  2. Progression-free survival (PFS) [ Time Frame: From randomization until death from any cause (up to approximately 7 years) ]
    Arm B vs. Arm C - PFS as assessed by RECIST v1.1 by the investigator

  3. Overall Survival (OS) [ Time Frame: From randomization until death from any cause (up to approximately 7 years) ]
    Arm B vs. Arm C


Secondary Outcome Measures :
  1. Confirmed Overall response rate (ORR) [ Time Frame: From randomization until death from any cause (up to approximately 7 years) ]
    Arm A vs. Arm B - ORR as assessed by RECIST v1.1 by the investigator

  2. Progression-free survival (PFS) [ Time Frame: From randomization until death from any cause (up to approximately 7 years) ]
    Arm A vs. Arm B - PFS as assessed by RECIST v1.1 by the investigator

  3. Confirmed Overall response rate (ORR) [ Time Frame: From randomization until death from any cause (up to approximately 7 years) ]
    Arm B vs. Arm C - ORR as assessed by RECIST v1.1 by the investigator



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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, squamous or nonsquamous, treatment-naive PD-L1 positive, NSCLC that is locally advanced or metastatic without sensitizing epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation
  • 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:

  • 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.

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


Contacts
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Contact: Medical Director 510-694-6220 clinicaltrials@arcusbio.com

Locations
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Hong Kong
Humanity and Health Clinical Trial Centre Recruiting
Hong Kong, Hong Kong
Contact: Chi Pan Lau         
Hong Kong United Oncology Centre Recruiting
Kowloon, Hong Kong
Contact: Yu Chung Li         
Malaysia
University Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia
Contact: Gwo Fuang Ho         
Hospital Pulau Pinang Recruiting
Pulau Pinang, Malaysia
Contact: Chin Heng Fong         
Sponsors and Collaborators
Arcus Biosciences, Inc.
Investigators
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Study Director: Medical Director Arcus Biosciences, Inc.
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Responsible Party: Arcus Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT04736173    
Other Study ID Numbers: ARC-10
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors