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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2026
  • participants needed
    625
  • sponsor
    Arcus Biosciences, Inc.
Updated on 29 July 2022
paclitaxel
cancer
monoclonal antibodies
measurable disease
growth factor
lung cancer
pemetrexed
carboplatin
epidermal growth factor receptor
EGFR
cancer chemotherapy
epidermal growth factor
lung carcinoma

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.

Details
Condition Non Small Cell Lung Cancer, Nonsquamous Non Small Cell Lung Cancer, Squamous Non-small-cell Lung Cancer, Lung Cancer
Treatment carboplatin, Paclitaxel, Pemetrexed, AB154, Zimberelimab, Domvanalimab
Clinical Study IdentifierNCT04736173
SponsorArcus Biosciences, Inc.
Last Modified on29 July 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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