Clinical trial NCT04262856: Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Nonsquamous Non Small Cell Lung Cancer
Squamous Non Small Cell Lung Cancer
Lung Cancer
Keywords: Non Small Cell Lung Cancer
Lung Cancer
NSCLC
Lead sponsor: Arcus Biosciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Gilead Sciences
First posted: 2020-02-10
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: From randomization until the first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
measure: Progression-free survival (PFS)
timeFrame: From randomization until the first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
Secondary outcomes:
measure: Duration of response (DoR)
timeFrame: From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
measure: Disease control rate (DCR)
timeFrame: From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
measure: Overall Survival (OS)
timeFrame: From randomization to death from any cause (up to approximately 5 years)
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: From Screening until up to 90-100 days after the last dose (approximately 5 years)
measure: Pharmacokinetics of zimberelimab
timeFrame: Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, 60 and 100 days post last dose (in total, an average of 2 years)
measure: Pharmacokinetics of domvanalimab
timeFrame: Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, 60 and 100 days post last dose (in total, an average of 2 years)
measure: Pharmacokinetics of etrumadenant
timeFrame: Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, 60 and 100 days post last dose (in total, an average of 2 years)
measure: Immunogenicity of zimberelimab
timeFrame: Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, and 100 days post last dose (in total, an average of 2 years).
measure: Immunogenicity of domvanalimab
timeFrame: Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, and 100 days post last dose (in total, an average of 2 years).
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Whittier
country: United States
facility: Innovative Clinical Research Institute (ICRI)
state: California
city: Englewood
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Gainesville
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tallahassee
country: United States
facility: Florida Cancer Specialists - Panhandle
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists - East
state: Florida
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Ridgewood
country: United States
facility: The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion
state: New Jersey
city: Lake Success
country: United States
facility: Clinical Research Alliance
state: New York
city: Lake Success
country: United States
facility: Northwell Health Cancer Institute
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Pittsburgh
country: United States
facility: Allegheny General Hospital (AGH)-Alleghney Singer Research Institute
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Fort Worth
country: United States
facility: The Center For Cancer And Blood Disorders (Texas Cancer Care)
state: Texas
city: Houston
country: United States
facility: Millennium Oncology
state: Texas
city: Blacksburg
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Albury
country: Australia
facility: Border Medical Oncology
city: Coffs Harbour
country: Australia
facility: Coffs Harbour Health Campus
city: Elizabeth Vale
country: Australia
facility: Adelaide Cancer Centre
city: Nowra
country: Australia
facility: Shoalhaven Cancer Care Centre
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC) - The Montreal Children's Hospital (MCH)
city: Hong Kong
country: Hong Kong
facility: Hong Kong United Oncology Centre
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital (Hong Kong)
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital (CBNUH)
city: Hwasun
country: Korea, Republic of
facility: Chonnam University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Suwon-si
country: Korea, Republic of
facility: St Vincent Hospital of the Catholic University of Korea
city: Uijeongbu
country: Korea, Republic of
facility: Catholic University of Korea, Uijeongbu St. Mary's Hospital
city: Singapore
country: Singapore
facility: Curie Oncology
city: New Taipei
country: Taiwan
facility: Taipei Medical University - Shuang Ho Hospital
city: Tainan City
country: Taiwan
facility: Chi Mei Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital at Linkou
Study officials:
affiliation: Arcus Biosciences, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: