Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-22 @ 5:07 AM
Study NCT ID:
NCT04262856
Status:
COMPLETED
Last Update Posted:
2025-08-26
First Post:
2020-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719848', 'term': 'zimberelimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2020-01-23', 'studyFirstSubmitQcDate': '2020-02-07', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'description': 'ORR as assessed by RECIST v1.1'}, {'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)', 'description': 'PFS as assessed by RECIST v1.1'}], 'secondaryOutcomes': [{'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)', 'description': 'DoR as assessed by RECIST v1.1'}, {'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)', 'description': 'DCR as assessed by RECIST v1.1'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomization to death from any cause (up to approximately 5 years)', 'description': 'OS as assessed at the time of PFS'}, {'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)', 'description': 'The number and percentage of participants that experience TEAE'}, {'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)', 'description': 'Serum concentration of zimberelimab as determined by validated assays'}, {'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)', 'description': 'Serum concentration of domvanalimab as determined by validated assays'}, {'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)', 'description': 'Serum concentration of etrumadenant as determined by validated assays'}, {'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).', 'description': 'Percentage of participants who develop treatment-emergent anti-drug antibodies to zimberelimab'}, {'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).', 'description': 'Percentage of participants who develop treatment-emergent anti-drug antibodies to domvanalimab'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non Small Cell Lung Cancer', 'Lung Cancer', 'NSCLC'], 'conditions': ['Non Small Cell Lung Cancer', 'Nonsquamous Non Small Cell Lung Cancer', 'Squamous Non Small Cell Lung Cancer', 'Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.arcusbio.com/study/?id=ARC-7', 'label': 'ARC-7 - Public website'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female participants; age ≥ 18 years\n* 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.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Must have at least 1 measurable lesion per RECIST v1.1\n* Adequate organ and marrow function\n\nExclusion Criteria:\n\n* Use of any live vaccines against infectious diseases within 28 days of first dose of investigational medicinal products (IMPs)\n* Any gastrointestinal condition that would preclude the use of oral medications (eg, difficulty swallowing, nausea, vomiting, or malabsorption)\n* History of trauma or major surgery within 28 days prior to the first dose of IMP\n* Concurrent medical condition requiring the use of supra-physiologic doses of corticosteroids (\\> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications\n* 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\n* 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.\n* 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'}, 'identificationModule': {'nctId': 'NCT04262856', 'acronym': 'ARC-7', 'briefTitle': 'Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arcus Biosciences, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ARC-7 (AB154CSP0002)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 (zimberelimab monotherapy)', 'description': 'Participants will receive zimberelimab as an intravenous (IV) infusion.', 'interventionNames': ['Drug: Zimberelimab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 (domvanalimab and zimberelimab combination therapy)', 'description': 'Participants will receive domvanalimab IV in combination with zimberelimab IV infusion.', 'interventionNames': ['Drug: Domvanalimab', 'Drug: Zimberelimab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy)', 'description': 'Participants will receive oral etrumadenant in combination with domvanalimab IV and zimberelimab IV infusion', 'interventionNames': ['Drug: Domvanalimab', 'Drug: Etrumadenant', 'Drug: Zimberelimab']}], 'interventions': [{'name': 'Domvanalimab', 'type': 'DRUG', 'otherNames': ['AB154'], 'description': 'Domvanalimab is a humanized monoclonal antibody targeting human TIGIT', 'armGroupLabels': ['Arm 2 (domvanalimab and zimberelimab combination therapy)', 'Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy)']}, {'name': 'Etrumadenant', 'type': 'DRUG', 'otherNames': ['AB928'], 'description': 'Etrumadenant is an A2aR and A2bR antagonist', 'armGroupLabels': ['Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy)']}, {'name': 'Zimberelimab', 'type': 'DRUG', 'otherNames': ['AB122'], 'description': 'Zimberelimab is a fully human anti-PD-1 monoclonal antibody', 'armGroupLabels': ['Arm 1 (zimberelimab monotherapy)', 'Arm 2 (domvanalimab and zimberelimab combination therapy)', 'Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Innovative Clinical Research Institute (ICRI)', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '34223', 'city': 'Englewood', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 26.96201, 'lon': -82.3526}}, {'zip': '32605', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists - Panhandle', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists - East', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Health Lexington', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Cancer Institute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic Foundation', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '07450', 'city': 'Ridgewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion', 'geoPoint': {'lat': 40.97926, 'lon': -74.11653}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Research Alliance', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health Cancer Institute', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Health', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital (AGH)-Alleghney Singer Research Institute', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'The Center For Cancer And Blood Disorders (Texas Cancer Care)', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77339', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Millennium Oncology', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '24060', 'city': 'Blacksburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care', 'geoPoint': {'lat': 37.22957, 'lon': -80.41394}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Cancer Specialists', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'city': 'Albury', 'country': 'Australia', 'facility': 'Border Medical Oncology', 'geoPoint': {'lat': -36.07482, 'lon': 146.92401}}, {'city': 'Coffs Harbour', 'country': 'Australia', 'facility': 'Coffs Harbour Health Campus', 'geoPoint': {'lat': -30.29626, 'lon': 153.11351}}, {'city': 'Elizabeth Vale', 'country': 'Australia', 'facility': 'Adelaide Cancer Centre', 'geoPoint': {'lat': -34.74857, 'lon': 138.66819}}, {'city': 'Nowra', 'country': 'Australia', 'facility': 'Shoalhaven Cancer Care Centre', 'geoPoint': {'lat': -34.88422, 'lon': 150.60036}}, {'city': 'Montreal', 'country': 'Canada', 'facility': "McGill University Health Centre (MUHC) - The Montreal Children's Hospital (MCH)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Hong Kong United Oncology Centre', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Elizabeth Hospital (Hong Kong)', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'Curie Oncology', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Kosin University Gospel Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Cheongju-si', 'country': 'South Korea', 'facility': 'Chungbuk National University Hospital (CBNUH)', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'city': 'Hwasun', 'country': 'South Korea', 'facility': 'Chonnam University Hospital', 'geoPoint': {'lat': 35.06125, 'lon': 126.98746}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Seongnam-si', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'country': 'South Korea', 'facility': 'St Vincent Hospital of the Catholic University of Korea', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Uijeongbu-si', 'country': 'South Korea', 'facility': "Catholic University of Korea, Uijeongbu St. Mary's Hospital", 'geoPoint': {'lat': 37.7415, 'lon': 127.0474}}, {'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Taipei Medical University - Shuang Ho Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Chi Mei Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital at Linkou', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Arcus Biosciences, Inc.'}]}, 'ipdSharingStatementModule': {'url': 'https://trials.arcusbio.com/our-transparency-policy', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES', 'description': 'Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \\[SAP\\], Clinical Study Report \\[CSR\\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.\n\nFor more information, please visit our website.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arcus Biosciences, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}