Overview

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

Status:
Recruiting
Trial end date:
2022-06-23
Target enrollment:
0
Participant gender:
All
Summary
This randomized phase 2 open-label study will evaluate the safety and efficacy of zimberelimab (AB122) monotherapy, domvanalimab (AB154) in combination with zimberelimab, and domvanalimab in combination with zimberelimab and etrumadenant (AB928) in front-line, PD-L1 positive, metastatic non-small cell lung cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Arcus Biosciences, Inc.
Criteria
Inclusion Criteria:

- Male or female participants; age ≥ 18 years

- Histologically confirmed squamous or nonsquamous, PD-L1 positive, NSCLC that is
metastatic without sensitizing epidermal growth factor receptor (EGFR) or anaplastic
lymphoma kinase (ALK) mutation expression

- 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:

- Use of any live vaccines against infectious diseases within 28 days of first dose

- Concurrent medical condition requiring the use of supra-physiologic doses of
corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive
medications

- Positive test results for Hepatitis B surface antigen, Hepatitis C virus antibody or
Hepatitis C qualitative RNA or human immunodeficiency virus-1 (HIV-1) antibody

- 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