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Study Comparing the Combination Domvanalimab and Zimberelimab With Pembrolizumab in Untreated Locally Advanced or Metastatic PD-L1-High Non-Small Cell Lung Cancer (ARC-10)

Primary Purpose

Non Small Cell Lung Cancer, Nonsquamous Non Small Cell Lung Cancer, Squamous Non Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Domvanalimab
Zimberelimab
Carboplatin
Paclitaxel
Pemetrexed
Pembrolizumab
Sponsored by
Arcus Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Non Small Cell Lung Cancer, Lung Cancer, NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed, squamous or nonsquamous, treatment-naive PD-L1 positive, NSCLC that is locally advanced or metastatic without sensitizing epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation
  • 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:

  • Presence of any tumor genomic aberration or driver mutation for which a targeted therapy is approved by local health authority and available
  • Use of any live vaccines against infectious diseases within 28 days of first dose
  • 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
  • Prior treatment with any anti-PD-1, anti-PD-L1 or any other antibody targeting an immune checkpoint.

Sites / Locations

  • Millennium Reasearch & Clinical DevelopmentRecruiting
  • Centricity ResearchRecruiting
  • Affinity Health Hope & Healing Cancer ServicesRecruiting
  • Gabrail Cancer CenterRecruiting
  • VA Notheast Ohio Healthcare System
  • Centricity Research Columbus Cancer CenterRecruiting
  • Millennium ResearchRecruiting
  • Lumi ResearchRecruiting
  • Blue Ridge Cancer CenterRecruiting
  • Ahsania Mission Cancer and General Hospital
  • Bangladesh Cancer Society Hospital and Welfare Home
  • Kurmitola General Hospital
  • Hospital de Câncer de Barretos - Fundação Pio XII
  • Associação Mário Pena - Núcleo de Ensino e Pesquisas Mário Penna
  • Hospital DF Star
  • CIONC-Centro Integrado de Oncologia de Curitiba
  • CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
  • Hospital de Caridade de Ijuí
  • Fundação Doutor Amaral Carvalho
  • Instituto Mederi de Pesquisa e Saude
  • Santiago Escovar, Carlos Eugênio
  • Instituto de Oncologia Saint Gallen
  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
  • Fundação Faculdade Regional de Medicina de São José do Rio Preto
  • IBCC - Instituto Brasileiro de Controle do Câncer
  • ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
  • CHU Rennes Hopital PontchaillouRecruiting
  • General Hospital of Athens "Alexandra"
  • General Hospital of Athens of Chest Diseases "SOTIRIA"
  • General Oncology Hospital of Kifissia "Agioi Anargyroi"Recruiting
  • University General Hospital "Attikon"
  • University General Hospital of LarissaRecruiting
  • University General Hospital "Attikon"Recruiting
  • General Oncology Hospital of Kifissia " Agioi Anargyroi"Recruiting
  • General Hospital of Patra "Agios Andreas"Recruiting
  • University General Hospital "Attikon"Recruiting
  • Hong Kong Integrated Oncology CentreRecruiting
  • Hong Kong United Oncology CentreRecruiting
  • Humanity and Health Clinical Trial CentreRecruiting
  • Princess Margaret HospitalRecruiting
  • Queen Mary HospitalRecruiting
  • Dong-A University HospitalRecruiting
  • Kosin University Gospel HospitalRecruiting
  • Chungbuk National University HospitalRecruiting
  • Keimyung University Dongsan HospitalRecruiting
  • The Catholic University of Korea Eunpyeong St Mary's HospitalRecruiting
  • Gachon University Gil Medical CentreRecruiting
  • Inha University HospitalRecruiting
  • The Catholic University of Korea Incheon St. Mary's HospitalRecruiting
  • Jeonbuk National University HospitalRecruiting
  • Cha Bundang Medical Centre Cha UniversityRecruiting
  • Samsung Medical CenterRecruiting
  • Asan Medical CentreRecruiting
  • Kangbuk Samsung HospitalRecruiting
  • Korea University Anam HospitalRecruiting
  • The Catholic University of Korea Seoul St Mary's Hospital
  • Ajou University HospitalRecruiting
  • The Catholic University of Korea St. Vincent Hospital
  • Universiti Kebangsaan MalaysiaRecruiting
  • Institut Kanser NegaraRecruiting
  • Hospital Sultan IsmailRecruiting
  • Hospital Kuala LumparRecruiting
  • Pantai Hospital Kuala LumpurRecruiting
  • University Malaya Medical CentreRecruiting
  • Hospital Tengku Ampuan AfzanRecruiting
  • Hospital Umum SarawakRecruiting
  • Hospital Pulau PinangRecruiting
  • Mount Miriam Cancer HospitalRecruiting
  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
  • Health Pharma Professional Research S.A. de C.V.
  • Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Oaxaca Site Management Organization S.C.
  • Oncologico Potosino
  • Hospital Goyeneche
  • Oncosalud
  • Clinica Ricardo Palma
  • Baguio General Hospital Medical Centre
  • Chong Hua Hospital
  • Metro Davao Medical and Research CentreRecruiting
  • Makati Medical CentreRecruiting
  • Philippine General HospitalRecruiting
  • University of Santo Tomas Hospital
  • St. Luke Medical Centre Quezon CityRecruiting
  • Clinical Center "Bezanijska kosa"
  • Clinical Center of Serbia
  • Oncomed System
  • Clinical Center Kragujevac
  • Clinical Center Nis
  • Institute for Pulmonary Diseases of Vojvodina
  • General Hospital Uzice
  • Slovak Research Center- team member, Ambulancia klinickej onkologieRecruiting
  • Vychodoslovensky onkologicky ustav, a.s.Recruiting
  • Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.
  • Nemocnica na okraji mesta, n.o.
  • Fakultna nemocnica Trnava
  • Tygerberg Hospital
  • Exellentis Clinical Trial ConsultantsRecruiting
  • Cancercare PERecruiting
  • The Medical Oncology Centre of RosebankRecruiting
  • West Rand Oncology CentreRecruiting
  • Wits Clinical Research CMJAH Clinical Trial SiteRecruiting
  • Little Company of Mary Oncology Centre - Mary Potter Cancer CentreRecruiting
  • University of Pretoria Medical OncologyRecruiting
  • Wilgers Oncology CentreRecruiting
  • Chang Gung Medical Foundation KaohsiungRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • China Medical University HospitalRecruiting
  • Chung Shan Medical University Hospital
  • Taichung Veterans General Hospital
  • Taipei Medical University HospitalRecruiting
  • Phramongkutklao HospitalRecruiting
  • Police General HospitalRecruiting
  • Rajavithi HospitalRecruiting
  • Vajira HospitalRecruiting
  • Prapokklao HospitalRecruiting
  • Maharaj Nakorn Chiang Mai HospitalRecruiting
  • Nakornping HospitalRecruiting
  • Srinagarind HospitalRecruiting
  • Lampang HospitalRecruiting
  • Maharat Nakhon Ratchasima HospitalRecruiting
  • Buddhachinaraj Phitsanulok HospitalRecruiting
  • Naresuan University HospitalRecruiting
  • Saraburi HospitalRecruiting
  • Songkhlanagarind HospitalRecruiting
  • Sunpasitthiprasing HospitalRecruiting
  • Udon Thani HospitalRecruiting
  • Adana City HospitalRecruiting
  • Baskent University Adana Application and Research Center
  • Cukurova University Medical FacultyRecruiting
  • Ankara City HospitalRecruiting
  • Gazi University Medical FacultyRecruiting
  • Hacettepe University Medical FacultyRecruiting
  • Memorial Ankara HospitalRecruiting
  • Dicle University, Medical facultyRecruiting
  • Trakya University Medical FacultyRecruiting
  • Acibadem Atakent HospitalRecruiting
  • Goztepe Prof. Dr. Suleyman Yalcin City HospitalRecruiting
  • Istanbul University Cerrahpasa - Cerrahpasa Medical FacultyRecruiting
  • Medipol University Medical FacultyRecruiting
  • Kocaeli Universitesi Tip FakultesiRecruiting
  • Inonu Uni. Med. Fac.Recruiting
  • Mersin University Medical FacultyRecruiting
  • Cần Thơ Oncology Hospital
  • Pham Ngo Thach Hospital
  • Huế Central HospitalRecruiting
  • 103 Military HospitalRecruiting
  • 175 Military Hospital
  • Bach Mai Hospital
  • Chợ Rẫy Hospital
  • Hanoi Oncology Hospital
  • HCM Oncology Hospital
  • Ho Chi Minh City University Medical Centre
  • National Lung HospitalRecruiting
  • Nghe An Oncology Hospital
  • People's Hospital 115
  • Vietnam National Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Experimental

Arm Label

Arm A - Study Part 1 (Platinum-based Chemotherapy)

Arm B - Study Part 1 (Zimberelimab Monotherapy)

Arm C - Study Part 1 (Domvanalimab + Zimberelimab Combination Therapy)

Arm D - Study Part 2 (Domvanalimab + Zimberelimab Combination Therapy)

Arm E - Study Part 2 (Pembrolizumab)

Arm Description

Participants will receive carboplatin, pemetrexed, and paclitaxel by intravenous (IV) infusion.

Participants will receive zimberelimab monotherapy by IV infusion.

Participants will receive zimberelimab in combination with AB154 by IV infusion.

Participants will receive domvanalimab in combination with zimberelimab by IV infusion.

Participants will receive pembrolizumab by IV infusion.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
Arm D vs. Arm E

Secondary Outcome Measures

Progression-free Survival (PFS)
Arm D vs. Arm E - PFS as assessed by RECIST v1.1 by blinded independent central review
Confirmed Overall Response Rate (ORR)
Arm D vs. Arm E - ORR as assessed by RECIST v1.1 by blinded independent central review
Number of Participants With treatment-emergent adverse events
Arm D vs. Arm E
Time to first symptom deterioration in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score
Arm D vs. Arm E

Full Information

First Posted
January 29, 2021
Last Updated
October 3, 2023
Sponsor
Arcus Biosciences, Inc.
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04736173
Brief Title
Study Comparing the Combination Domvanalimab and Zimberelimab With Pembrolizumab in Untreated Locally Advanced or Metastatic PD-L1-High Non-Small Cell Lung Cancer
Acronym
ARC-10
Official Title
A Phase 3 Study to Evaluate Zimberelimab (AB122) Combined With AB154 in Front-Line, PD-L1-High, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
July 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arcus Biosciences, Inc.
Collaborators
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a phase 3 study to evaluate zimberelimab (AB122) combined with domvanalimab (AB154) compared to pembrolizumab in front-line, PD-L1-high, locally advanced or metastatic NSCLC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A - Study Part 1 (Platinum-based Chemotherapy)
Arm Type
Active Comparator
Arm Description
Participants will receive carboplatin, pemetrexed, and paclitaxel by intravenous (IV) infusion.
Arm Title
Arm B - Study Part 1 (Zimberelimab Monotherapy)
Arm Type
Experimental
Arm Description
Participants will receive zimberelimab monotherapy by IV infusion.
Arm Title
Arm C - Study Part 1 (Domvanalimab + Zimberelimab Combination Therapy)
Arm Type
Active Comparator
Arm Description
Participants will receive zimberelimab in combination with AB154 by IV infusion.
Arm Title
Arm D - Study Part 2 (Domvanalimab + Zimberelimab Combination Therapy)
Arm Type
Experimental
Arm Description
Participants will receive domvanalimab in combination with zimberelimab by IV infusion.
Arm Title
Arm E - Study Part 2 (Pembrolizumab)
Arm Type
Experimental
Arm Description
Participants will receive pembrolizumab by IV infusion.
Intervention Type
Drug
Intervention Name(s)
Domvanalimab
Other Intervention Name(s)
AB154
Intervention Description
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
Intervention Type
Drug
Intervention Name(s)
Zimberelimab
Other Intervention Name(s)
AB122
Intervention Description
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Pembrolizumab is a humanized Immunoglobulin G4 monoclonal antibody targeting the PD-1 receptor
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Arm D vs. Arm E
Time Frame
From randomization until death from any cause (up to approximately 7 years)
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
Arm D vs. Arm E - PFS as assessed by RECIST v1.1 by blinded independent central review
Time Frame
From randomization until death from any cause (up to approximately 7 years)
Title
Confirmed Overall Response Rate (ORR)
Description
Arm D vs. Arm E - ORR as assessed by RECIST v1.1 by blinded independent central review
Time Frame
From randomization until death from any cause (up to approximately 7 years)
Title
Number of Participants With treatment-emergent adverse events
Description
Arm D vs. Arm E
Time Frame
From randomization until death from any cause (up to approximately 7 years)
Title
Time to first symptom deterioration in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score
Description
Arm D vs. Arm E
Time Frame
From randomization until death from any cause (up to approximately 7 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed, treatment naïve, locally advanced or metastatic (stage IIIB IV per AJCC version 8), squamous or non-squamous NSCLC with documented high PD L1 expression (TC ≥ 50%) as determined by the VENTANA SP263 IHC assay, as assessed by central laboratories). 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 If a participant has brain or meningeal metastases, the participant must meet the following criteria: Have no evidence of progression by neurologic symptoms or signs for at least 4 weeks prior to the first dose. Participants with previously treated brain metastases may participate provided they have stable central nervous system (CNS) disease for at least 4 weeks prior to enrollment. Stable CNS disease is defined as resolution of all neurologic symptoms to baseline, having no evidence of new or enlarging brain metastases, and not requiring use of corticosteroids for CNS disease for at least 14 days prior to the start of study treatment. Participants who have had brain metastases resected or have received whole brain radiotherapy ending at least 4 weeks (or stereotactic radiotherapy ending at least 2 weeks) prior to initiation of study treatment are permitted. Carcinomatous meningitis is excluded regardless of clinical stability. Exclusion Criteria: Presence of any tumor genomic aberration or driver mutation for which a targeted therapy is approved by local health authority and available Use of any live vaccines against infectious diseases within 28 days of first dose 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 Prior treatment with any anti-PD-1, anti-PD-L1 or any other antibody targeting an immune checkpoint. Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Director
Phone
+1-510-462-3330
Email
ClinicalTrials@arcusbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Arcus Biosciences, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Millennium Reasearch & Clinical Development
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Individual Site Status
Recruiting
Facility Name
Centricity Research
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Recruiting
Facility Name
Affinity Health Hope & Healing Cancer Services
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Individual Site Status
Recruiting
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Name
VA Notheast Ohio Healthcare System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Centricity Research Columbus Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Recruiting
Facility Name
Millennium Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Individual Site Status
Recruiting
Facility Name
Lumi Research
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Individual Site Status
Recruiting
Facility Name
Blue Ridge Cancer Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Name
Ahsania Mission Cancer and General Hospital
City
Dhaka
Country
Bangladesh
Individual Site Status
Not yet recruiting
Facility Name
Bangladesh Cancer Society Hospital and Welfare Home
City
Dhaka
Country
Bangladesh
Individual Site Status
Not yet recruiting
Facility Name
Kurmitola General Hospital
City
Dhaka
Country
Bangladesh
Individual Site Status
Not yet recruiting
Facility Name
Hospital de Câncer de Barretos - Fundação Pio XII
City
Barretos
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Associação Mário Pena - Núcleo de Ensino e Pesquisas Mário Penna
City
Belo Horizonte
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Hospital DF Star
City
Brasília
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
CIONC-Centro Integrado de Oncologia de Curitiba
City
Curitiba
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
City
Florianópolis
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Hospital de Caridade de Ijuí
City
Ijuí
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Fundação Doutor Amaral Carvalho
City
Jaú
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Instituto Mederi de Pesquisa e Saude
City
Passo Fundo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Santiago Escovar, Carlos Eugênio
City
Porto Alegre
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Instituto de Oncologia Saint Gallen
City
Santa Cruz do Sul
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
City
Santo André
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Fundação Faculdade Regional de Medicina de São José do Rio Preto
City
São José Do Rio Preto
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
IBCC - Instituto Brasileiro de Controle do Câncer
City
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
City
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
CHU Rennes Hopital Pontchaillou
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Name
General Hospital of Athens "Alexandra"
City
Athens
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
General Hospital of Athens of Chest Diseases "SOTIRIA"
City
Athens
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
General Oncology Hospital of Kifissia "Agioi Anargyroi"
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital "Attikon"
City
Athens
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
University General Hospital of Larissa
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital "Attikon"
City
Chaïdári
Country
Greece
Individual Site Status
Recruiting
Facility Name
General Oncology Hospital of Kifissia " Agioi Anargyroi"
City
Kifisiá
Country
Greece
Individual Site Status
Recruiting
Facility Name
General Hospital of Patra "Agios Andreas"
City
Larissa
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital "Attikon"
City
Patra
Country
Greece
Individual Site Status
Recruiting
Facility Name
Hong Kong Integrated Oncology Centre
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Hong Kong United Oncology Centre
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Chung Li
Facility Name
Humanity and Health Clinical Trial Centre
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi Pan Lau
Facility Name
Princess Margaret Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kosin University Gospel Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chungbuk National University Hospital
City
Cheongju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea Eunpyeong St Mary's Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gachon University Gil Medical Centre
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea Incheon St. Mary's Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Jeonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Cha Bundang Medical Centre Cha University
City
Seongnam
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Centre
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kangbuk Samsung Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea Seoul St Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Ajou University Hospital
City
Suwon-Si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea St. Vincent Hospital
City
Suwon-Si
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Universiti Kebangsaan Malaysia
City
Cheras
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Institut Kanser Negara
City
Jalan Baharu
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Sultan Ismail
City
Johor Bahru
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Kuala Lumpar
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Pantai Hospital Kuala Lumpur
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Tengku Ampuan Afzan
City
Kuantan
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Umum Sarawak
City
Kuching
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Pulau Pinang
City
Pulau Pinang
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chin Heng Fong
Facility Name
Mount Miriam Cancer Hospital
City
Tanjung Bungah
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Health Pharma Professional Research S.A. de C.V.
City
Mexico City
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
City
Monterrey
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Oaxaca Site Management Organization S.C.
City
Oaxaca
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Oncologico Potosino
City
San Luis Potosi
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Hospital Goyeneche
City
Arequipa
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Oncosalud
City
San Borja
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Clinica Ricardo Palma
City
San Isidro
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Baguio General Hospital Medical Centre
City
Baguio City
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Chong Hua Hospital
City
Cebu City
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Metro Davao Medical and Research Centre
City
Davao City
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Makati Medical Centre
City
Makati City
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Philippine General Hospital
City
Manila
Country
Philippines
Individual Site Status
Recruiting
Facility Name
University of Santo Tomas Hospital
City
Manila
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
St. Luke Medical Centre Quezon City
City
Quezon City
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Clinical Center "Bezanijska kosa"
City
Belgrade
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Clinical Center of Serbia
City
Belgrade
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Oncomed System
City
Belgrade
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Clinical Center Kragujevac
City
Kragujevac
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Clinical Center Nis
City
Nis
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Institute for Pulmonary Diseases of Vojvodina
City
Sremska Kamenica
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
General Hospital Uzice
City
Uzice
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Slovak Research Center- team member, Ambulancia klinickej onkologie
City
Banka
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Vychodoslovensky onkologicky ustav, a.s.
City
Kosice
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.
City
Michalovce
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Nemocnica na okraji mesta, n.o.
City
Partizanske
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Fakultna nemocnica Trnava
City
Trnava
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Tygerberg Hospital
City
Cape Town
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Exellentis Clinical Trial Consultants
City
George
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Cancercare PE
City
Johannesburg
Country
South Africa
Individual Site Status
Recruiting
Facility Name
The Medical Oncology Centre of Rosebank
City
Johannesburg
Country
South Africa
Individual Site Status
Recruiting
Facility Name
West Rand Oncology Centre
City
Johannesburg
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Wits Clinical Research CMJAH Clinical Trial Site
City
Johannesburg
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Little Company of Mary Oncology Centre - Mary Potter Cancer Centre
City
Pretoria
Country
South Africa
Individual Site Status
Recruiting
Facility Name
University of Pretoria Medical Oncology
City
Pretoria
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Wilgers Oncology Centre
City
Pretoria
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Chang Gung Medical Foundation Kaohsiung
City
Kaohsiung City
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung City
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung City
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chung Shan Medical University Hospital
City
Taichung City
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Taichung Veterans General Hospital
City
Taichung City
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Taipei Medical University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Phramongkutklao Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Police General Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Rajavithi Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Vajira Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Prapokklao Hospital
City
Chanthaburi
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Chiang Mai
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Nakornping Hospital
City
Chiang Mai
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Srinagarind Hospital
City
Khon Kaen
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Lampang Hospital
City
Lampang
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Maharat Nakhon Ratchasima Hospital
City
Nakhon Ratchasima
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Buddhachinaraj Phitsanulok Hospital
City
Phitsanulok
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Naresuan University Hospital
City
Phitsanulok
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Saraburi Hospital
City
Saraburi
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Songkhlanagarind Hospital
City
Songkhla
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Sunpasitthiprasing Hospital
City
Ubon Ratchathani
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Udon Thani Hospital
City
Udon Thani
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Adana City Hospital
City
Adana
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Baskent University Adana Application and Research Center
City
Adana
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Cukurova University Medical Faculty
City
Adana
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara City Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gazi University Medical Faculty
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Hacettepe University Medical Faculty
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Memorial Ankara Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dicle University, Medical faculty
City
Diyarbakir
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Trakya University Medical Faculty
City
Edirne
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Acibadem Atakent Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medipol University Medical Faculty
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kocaeli Universitesi Tip Fakultesi
City
Kocaeli
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Inonu Uni. Med. Fac.
City
Malatya
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Mersin University Medical Faculty
City
Mersin
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Cần Thơ Oncology Hospital
City
Cần Thơ
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Name
Pham Ngo Thach Hospital
City
Ho Chi Minh City
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Name
Huế Central Hospital
City
Huế
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
103 Military Hospital
City
Hà Nội
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
175 Military Hospital
City
Hà Nội
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Name
Bach Mai Hospital
City
Hà Nội
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Name
Chợ Rẫy Hospital
City
Hà Nội
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Name
Hanoi Oncology Hospital
City
Hà Nội
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Name
HCM Oncology Hospital
City
Hà Nội
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Name
Ho Chi Minh City University Medical Centre
City
Hà Nội
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Name
National Lung Hospital
City
Hà Nội
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Nghe An Oncology Hospital
City
Hà Nội
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Name
People's Hospital 115
City
Hà Nội
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Name
Vietnam National Cancer Hospital
City
Hà Nội
Country
Vietnam
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan 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. For more information, please visit our website.
IPD Sharing URL
https://trials.arcusbio.com/our-transparency-policy

Learn more about this trial

Study Comparing the Combination Domvanalimab and Zimberelimab With Pembrolizumab in Untreated Locally Advanced or Metastatic PD-L1-High Non-Small Cell Lung Cancer

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