NCT04262856CompletedPhase 2
Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer
A Phase 2 Study to Evaluate the Safety and Efficacy of AB122 Monotherapy, AB154 in Combination With AB122, and AB154 in Combination With AB122 and AB928 in Front-Line, Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 151 (actual)
- First submitted
- 23 Jan 2020
- Start date
- 28 May 2020
- Primary completion date
- 9 Jul 2025
- Lead sponsor
- Arcus Biosciences, Inc.
- Diseases
- Lung cancer
- NCT number
- NCT04262856
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 151
- From 28 May 2020 to the primary completion date, 9 Jul 2025
- 44 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (44)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Border Medical Oncology Coordinator of this site? Confirm its status | Albury | Australia | Unknown status |
| Coffs Harbour Health Campus Coordinator of this site? Confirm its status | Coffs Harbour | Australia | Unknown status |
| Adelaide Cancer Centre Coordinator of this site? Confirm its status | Elizabeth Vale | Australia | Unknown status |
| Shoalhaven Cancer Care Centre Coordinator of this site? Confirm its status | Nowra | Australia | Unknown status |
| McGill University Health Centre (MUHC) - The Montreal Children's Hospital (MCH) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Hong Kong United Oncology Centre Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Queen Elizabeth Hospital Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Kosin University Gospel Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Chungbuk National University Hospital (CBNUH) Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| Chonnam University Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Unknown status |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Chonbuk National University Hospital Coordinator of this site? Confirm its status | Jeonju | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| St Vincent Hospital of the Catholic University of Korea Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Catholic University of Korea, Uijeongbu St. Mary's Hospital Coordinator of this site? Confirm its status | Uijeongbu-si | South Korea | Unknown status |
| Curie Oncology Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Taipei Medical University Shuang Ho Hospital Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| Chi Mei Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Medical University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Memorial Hospital at Linkou Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care Coordinator of this site? Confirm its status | Blacksburg | United States | Unknown status |
| Florida Cancer Specialists Coordinator of this site? Confirm its status | Englewood | United States | Unknown status |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| The Center For Cancer And Blood Disorders (Texas Cancer Care) Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Florida Cancer Specialists Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Millennium Oncology Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Clinical Research Alliance Coordinator of this site? Confirm its status | Lake Success | United States | Unknown status |
| Northwell Health Cancer Institute Coordinator of this site? Confirm its status | Lake Success | United States | Unknown status |
| Baptist Health Lexington Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Norton Cancer Institute Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Ochsner Clinic Foundation Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Allegheny General Hospital (AGH)-Alleghney Singer Research Institute Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion Coordinator of this site? Confirm its status | Ridgewood | United States | Unknown status |
| Florida Cancer Specialists-Panhandle Coordinator of this site? Confirm its status | Tallahassee | United States | Unknown status |
| Florida Cancer Specialists - East Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
| Innovative Clinical Research Institute (ICRI) Coordinator of this site? Confirm its status | Whittier | United States | Unknown status |
| Wake Forest Baptist Health Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.