Study With Immunotherapy Combinations in Participants With Metastatic Non-Small Cell Lung Cancer (EDGE-Lung)

  • STATUS
    Recruiting
  • End date
    Sep 10, 2026
  • participants needed
    320
  • sponsor
    Arcus Biosciences, Inc.
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Updated on 10 January 2023
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Summary

The purpose of this study is to assess the objective response rate (ORR) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy.

Details
Condition Advanced Non-Small Cell Lung Cancer
Age 18years or above
Treatment Zimberelimab, Docetaxel, Domvanalimab, Quemliclustat, Platinum-Based Doublet
Clinical Study IdentifierNCT05676931
SponsorArcus Biosciences, Inc.
Last Modified on10 January 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

Histologically confirmed, documented diagnosis of Stage IV metastatic, NSCLC
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1
At least one measurable target lesion per RECIST v1.1
Adequate organ and marrow function
Participants must be willing to provide adequate tumor tissue

Exclusion Criteria

Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of Investigational Product(s) (IPs) hazardous
Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s)
Concurrent chronic medical condition requiring the use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications (absorbable topical corticosteroids are not excluded)
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
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
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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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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