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.
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).
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
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There are 59 Locations for this study
Birmingham Alabama, 35294, United States
Anaheim California, 92801, United States
Whittier California, 90603, United States
Englewood Florida, 34223, United States
Gainesville Florida, 32605, United States
Saint Petersburg Florida, 33705, United States
Tallahassee Florida, 32308, United States
West Palm Beach Florida, 33401, United States
Lexington Kentucky, 40503, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40207, United States
New Orleans Louisiana, 70121, United States
Bethesda Maryland, 20817, United States
Farmington Hills Michigan, 48334, United States
Hattiesburg Mississippi, 39401, United States
Las Vegas Nevada, 89196, United States
Ridgewood New Jersey, 07450, United States
Lake Success New York, 11042, United States
Lake Success New York, 11042, United States
Winston-Salem North Carolina, 27157, United States
Pittsburgh Pennsylvania, 15224, United States
Greenville South Carolina, 29605, United States
Nashville Tennessee, 37203, United States
Fort Worth Texas, 76104, United States
Kingwood Texas, 77339, United States
Lubbock Texas, 79410, United States
Tyler Texas, 75701, United States
Blacksburg Virginia, 24060, United States
Fairfax Virginia, 22031, United States
Albury New South Wales, 2640, Australia
Coffs Harbour New South Wales, 2450, Australia
Nowra New South Wales, 2500, Australia
Tweed Heads New South Wales, 2485, Australia
Elizabeth Vale South Australia, 5112, Australia
Brampton , L6R 3, Canada
Montréal , H4A 3, Canada
Saint Jerome , J7Z 5, Canada
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Busan , 49267, Korea, Republic of
Hwasun , 58128, Korea, Republic of
Incheon , 21565, Korea, Republic of
Jeonju , 54907, Korea, Republic of
Seongnam-si , 13620, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03181, Korea, Republic of
Seoul , 2841, Korea, Republic of
Seoul , 5505, Korea, Republic of
Suwon-si , 16247, Korea, Republic of
Uijeongbu , 11765, Korea, Republic of
Singapore , 18877, Singapore
Singapore , 25849, Singapore
Singapore , 32956, Singapore
Kaohsiung City , 83301, Taiwan
Kaohsiung , , Taiwan
New Taipei , 23561, Taiwan
Taichung City , 40201, Taiwan
Tainan City , 736, Taiwan
Tainan , 704, Taiwan
Taipei City , 114, Taiwan
Taipei , 10002, Taiwan
Taipei , 110, Taiwan
Taoyuan , 333, Taiwan
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