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

Completed · Phase 2

Conditions studied: Non Small Cell Lung Cancer, Nonsquamous Non Small Cell Lung Cancer, Squamous Non Small Cell Lung Cancer, Lung Cancer

In brief

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.

Key facts

Study ID

NCT04262856

Run by

Arcus Biosciences, Inc.

People needed

151

Starts

2020-05-28

Expected to finish

2025-07-09

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants; age ≥ 18 years
• Histologically confirmed, treatment naive, metastatic squamous or non-squamous NSCLC with documented high PD-L1 expression, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
• 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

You may not qualify if…

• Use of any live vaccines against infectious diseases within 28 days of first dose of investigational medicinal products (IMPs)
• Any gastrointestinal condition that would preclude the use of oral medications (eg, difficulty swallowing, nausea, vomiting, or malabsorption)
• History of trauma or major surgery within 28 days prior to the first dose of IMP
• 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 with presence of Hepatitis C qualitative RNA or human immunodeficiency virus (HIV-1 and/or HIV-2) antibody at screening
• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Innovative Clinical Research Institute (ICRI) — Whittier, California, United States
• Florida Cancer Specialists — Englewood, Florida, United States
• Florida Cancer Specialists — Gainesville, Florida, United States
• Florida Cancer Specialists - Panhandle — Tallahassee, Florida, United States
• Florida Cancer Specialists - East — West Palm Beach, Florida, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion — Ridgewood, New Jersey, United States
• Clinical Research Alliance — Lake Success, New York, United States
• Northwell Health Cancer Institute — Lake Success, New York, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• Allegheny General Hospital (AGH)-Alleghney Singer Research Institute — Pittsburgh, Pennsylvania, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• The Center For Cancer And Blood Disorders (Texas Cancer Care) — Fort Worth, Texas, United States
• Millennium Oncology — Houston, Texas, United States
• Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care — Blacksburg, Virginia, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• Border Medical Oncology — Albury, Australia
• Coffs Harbour Health Campus — Coffs Harbour, Australia
• Adelaide Cancer Centre — Elizabeth Vale, Australia
• Shoalhaven Cancer Care Centre — Nowra, Australia
• McGill University Health Centre (MUHC) - The Montreal Children's Hospital (MCH) — Montreal, Canada
• Hong Kong United Oncology Centre — Hong Kong, Hong Kong

Full record on ClinicalTrials.gov

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