Lung Cancer Clinical Trial

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

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.

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Full Description

This is an open-label phase 2 study in participants with non-small cell lung cancer which will assess the safety, efficacy and tolerability of zimberelimab as monotherapy and in combination with other immunotherapeutics across multiple treatment arms.

Approximately 150 participants will be randomized to 1 of 3 treatment arms: 1) zimberelimab, 2) zimberelimab + domvanalimab (anti-TIGIT antibody), 3) zimberelimab + domvanalimab + etrumadenant (dual adenosine receptor antagonist). Participants that progress on the zimberelimab monotherapy arm may cross-over to receive the third arm combination of zimberelimab + domvanalimab + etrumadenant.

The primary objective of this clinical study is to evaluate the efficacy of each combination therapy by assessing: 1) objective response rate (ORR) of participants with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and 2) progression free survival (PFS).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male or female participants; age ≥ 18 years
Histologically confirmed, treatment naïve, 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

Exclusion Criteria:

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

151

Study ID:

NCT04262856

Recruitment Status:

Active, not recruiting

Sponsor:

Arcus Biosciences, Inc.

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There are 59 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Pacific Cancer Medical Center, Inc
Anaheim California, 92801, United States
Innovative Clinical Research Institute (ICRI)
Whittier California, 90603, United States
Florida Cancer Specialists
Englewood Florida, 34223, United States
Florida Cancer Specialists
Gainesville Florida, 32605, United States
Florida Cancer Specialists
Saint Petersburg Florida, 33705, United States
Florida Cancer Specialists - Panhandle
Tallahassee Florida, 32308, United States
Florida Cancer Specialists - East
West Palm Beach Florida, 33401, United States
Baptist Health Lexington
Lexington Kentucky, 40503, United States
Norton Cancer Institute
Louisville Kentucky, 40202, United States
Baptist Hospital East
Louisville Kentucky, 40207, United States
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
American Oncology Partners of Maryland, PA
Bethesda Maryland, 20817, United States
Detroit Clinical Research Center, PC
Farmington Hills Michigan, 48334, United States
Hattiesburg Clinic
Hattiesburg Mississippi, 39401, United States
Comprehensive Cancer Centers Of Nevada
Las Vegas Nevada, 89196, United States
The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion
Ridgewood New Jersey, 07450, United States
Clinical Research Alliance
Lake Success New York, 11042, United States
Northwell Health Cancer Institute
Lake Success New York, 11042, United States
Wake Forest Baptist Health
Winston-Salem North Carolina, 27157, United States
Allegheny General Hospital (AGH)-Alleghney Singer Research Institute
Pittsburgh Pennsylvania, 15224, United States
Prisma Health-Upstate
Greenville South Carolina, 29605, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
The Center For Cancer And Blood Disorders (Texas Cancer Care)
Fort Worth Texas, 76104, United States
Dr.John R Waldron, MD Off of
Kingwood Texas, 77339, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock Texas, 79410, United States
Tyler Hematology-Oncology, P.A.
Tyler Texas, 75701, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg Virginia, 24060, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Border Medical Oncology
Albury New South Wales, 2640, Australia
Coffs Harbour Health Campus
Coffs Harbour New South Wales, 2450, Australia
Shoalhaven Cancer Care Centre
Nowra New South Wales, 2500, Australia
Tweed Hospital
Tweed Heads New South Wales, 2485, Australia
Adelaide Cancer Centre
Elizabeth Vale South Australia, 5112, Australia
Brampton Civic Hospital (Bch), William Osler Health Centre
Brampton , L6R 3, Canada
McGill University Health Centre (MUHC) - The Montreal Children's Hospital (MCH)
Montréal , H4A 3, Canada
Centre Integre de Sante et de Services Sociaux des Laurentides Hopital regional de Saint-Jerome
Saint Jerome , J7Z 5, Canada
Hong Kong United Oncology Centre
Hong Kong , , Hong Kong
Humanity and Health Research Center
Hong Kong , , Hong Kong
Princess Margaret Hospital
Hong Kong , , Hong Kong
Queen Elizabeth Hospital (Hong Kong)
Hong Kong , , Hong Kong
Kosin University Gospel Hospital
Busan , 49267, Korea, Republic of
Chonnam University Hospital
Hwasun , 58128, Korea, Republic of
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of
Chonbuk National University Hospital
Jeonju , 54907, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , 13620, Korea, Republic of
Korea University Anam Hospital
Seoul , 02841, Korea, Republic of
Kangbuk Samsung Hospital
Seoul , 03181, Korea, Republic of
Korea University Anam Hospital
Seoul , 2841, Korea, Republic of
Asan Medical Center
Seoul , 5505, Korea, Republic of
St Vincent Hospital of the Catholic University of Korea
Suwon-si , 16247, Korea, Republic of
Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu , 11765, Korea, Republic of
Raffles Hospital
Singapore , 18877, Singapore
Oncocare Cancer Centre
Singapore , 25849, Singapore
Curie Oncology
Singapore , 32956, Singapore
Chang Gung Memorial Hospital, Kaohsiung Branch
Kaohsiung City , 83301, Taiwan
Chang Gung Memorial Hospital
Kaohsiung , , Taiwan
Taipei Medical University - Shuang Ho Hospital
New Taipei , 23561, Taiwan
Chung Shan Medical University Hospital
Taichung City , 40201, Taiwan
Chi Mei Hospital
Tainan City , 736, Taiwan
National Cheng Kung University Hospital
Tainan , 704, Taiwan
Tri-Service General Hospital
Taipei City , 114, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Taipei Medical University Hospital
Taipei , 110, Taiwan
Chang Gung Memorial Hospital at Linkou
Taoyuan , 333, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

151

Study ID:

NCT04262856

Recruitment Status:

Active, not recruiting

Sponsor:


Arcus Biosciences, Inc.

How clear is this clinincal trial information?

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