Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

169

Study ID:

NCT04736173

Recruitment Status:

Active, not recruiting

Sponsor:

Arcus Biosciences, Inc.

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There are 9 Locations for this study

See Locations Near You

Millennium Reasearch & Clinical Development
Thousand Oaks California, 91360, United States
Centricity Research
Columbus Georgia, 31904, United States
Affinity Health Hope & Healing Cancer Services
Hinsdale Illinois, 60521, United States
Gabrail Cancer Center
Canton Ohio, 44718, United States
VA Notheast Ohio Healthcare System
Cleveland Ohio, 44106, United States
Centricity Research Columbus Cancer Center
Columbus Ohio, 31904, United States
Millennium Research
Houston Texas, 77090, United States
Lumi Research
Kingwood Texas, 77339, United States
Blue Ridge Cancer Center
Roanoke Virginia, 24014, United States
Ahsania Mission Cancer and General Hospital
Dhaka , , Bangladesh
Bangladesh Cancer Society Hospital and Welfare Home
Dhaka , , Bangladesh
Kurmitola General Hospital
Dhaka , , Bangladesh
Hospital de Câncer de Barretos - Fundação Pio XII
Barretos , , Brazil
Associação Mário Pena - Núcleo de Ensino e Pesquisas Mário Penna
Belo Horizonte , , Brazil
Hospital DF Star
Brasília , , Brazil
CIONC-Centro Integrado de Oncologia de Curitiba
Curitiba , , Brazil
CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
Florianópolis , , Brazil
Hospital de Caridade de Ijuí
Ijuí , , Brazil
Fundação Doutor Amaral Carvalho
Jaú , , Brazil
Instituto Mederi de Pesquisa e Saude
Passo Fundo , , Brazil
Santiago Escovar, Carlos Eugênio
Porto Alegre , , Brazil
Instituto de Oncologia Saint Gallen
Santa Cruz do Sul , , Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André , , Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José Do Rio Preto , , Brazil
IBCC - Instituto Brasileiro de Controle do Câncer
São Paulo , , Brazil
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo , , Brazil
Hôpital Ambroise Paré
Boulogne-Billancourt , , France
Center Hospitalier Intercommunal de creteil
Créteil , , France
CHU de Poitiers
Poitiers , , France
CHU Rennes Hopital Pontchaillou
Rennes , , France
Hopital Larrey
Toulouse , , France
General Hospital of Athens "Alexandra"
Athens , , Greece
General Hospital of Athens of Chest Diseases "SOTIRIA"
Athens , , Greece
General Oncology Hospital of Kifissia "Agioi Anargyroi"
Athens , , Greece
University General Hospital "Attikon"
Athens , , Greece
University General Hospital of Larissa
Athens , , Greece
University General Hospital "Attikon"
Chaïdári , , Greece
General Oncology Hospital of Kifissia " Agioi Anargyroi"
Kifisiá , , Greece
General Hospital of Patra "Agios Andreas"
Larissa , , Greece
University General Hospital "Attikon"
Patra , , Greece
Hong Kong Integrated Oncology Centre
Hong Kong , , Hong Kong
Hong Kong United Oncology Centre
Hong Kong , , Hong Kong
Humanity and Health Clinical Trial Centre
Hong Kong , , Hong Kong
Princess Margaret Hospital
Hong Kong , , Hong Kong
Queen Mary Hospital
Hong Kong , , Hong Kong
Dong-A University Hospital
Busan , , Korea, Republic of
Kosin University Gospel Hospital
Busan , , Korea, Republic of
Chungbuk National University Hospital
Cheongju , , Korea, Republic of
Keimyung University Dongsan Hospital
Daegu , , Korea, Republic of
The Catholic University of Korea Eunpyeong St Mary's Hospital
Gyeonggi-do , , Korea, Republic of
Gyeongsang National University Hospital
Gyeongsang , , Korea, Republic of
Gachon University Gil Medical Centre
Incheon , , Korea, Republic of
Inha University Hospital
Incheon , , Korea, Republic of
The Catholic University of Korea Incheon St. Mary's Hospital
Incheon , , Korea, Republic of
Jeonbuk National University Hospital
Jeonju , , Korea, Republic of
Cha Bundang Medical Centre Cha University
Seongnam , , Korea, Republic of
Samsung Medical Center
Seoul , 6351, Korea, Republic of
Asan Medical Centre
Seoul , , Korea, Republic of
Gangnam Severance Hospital
Seoul , , Korea, Republic of
Kangbuk Samsung Hospital
Seoul , , Korea, Republic of
Korea University Anam Hospital
Seoul , , Korea, Republic of
The Catholic University of Korea Seoul St Mary's Hospital
Seoul , , Korea, Republic of
Ajou University Hospital
Suwon-Si , , Korea, Republic of
The Catholic University of Korea St. Vincent Hospital
Suwon-Si , , Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan , , Korea, Republic of
Universiti Kebangsaan Malaysia
Cheras , , Malaysia
Institut Kanser Negara
Jalan Baharu , , Malaysia
Hospital Sultan Ismail
Johor Bahru , , Malaysia
Hospital Kuala Lumpar
Kuala Lumpur , , Malaysia
Pantai Hospital Kuala Lumpur
Kuala Lumpur , , Malaysia
University Malaya Medical Centre
Kuala Lumpur , , Malaysia
Hospital Tengku Ampuan Afzan
Kuantan , , Malaysia
Hospital Umum Sarawak
Kuching , , Malaysia
Hospital Pulau Pinang
Pulau Pinang , , Malaysia
Mount Miriam Cancer Hospital
Tanjung Bungah , , Malaysia
Health Pharma Professional Research
Benito Juarez , , Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara , , Mexico
Hospital Civil Fray Antonio Alcalde
Guadalajara , , Mexico
Health Pharma Professional Research S.A. de C.V.
Mexico City , , Mexico
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey , , Mexico
Oaxaca Site Management Organization S.C.
Oaxaca , , Mexico
Oncologico Potosino
San Luis Potosi , , Mexico
Hospital Goyeneche
Arequipa , , Peru
Oncosalud
San Borja , , Peru
Clinica Ricardo Palma
San Isidro , , Peru
Baguio General Hospital Medical Centre
Baguio City , , Philippines
Chung Shan Medical University Hospital
Cebu City , , Philippines
Chong Hua Hospital
Cebu , , Philippines
Metro Davao Medical and Research Centre
Davao City , , Philippines
Makati Medical Centre
Makati City , , Philippines
Philippine General Hospital
Manila , , Philippines
University of Santo Tomas Hospital
Manila , , Philippines
St. Luke Medical Centre Quezon City
Quezon City , , Philippines
Clinical Center "Bezanijska kosa"
Belgrade , , Serbia
Clinical Center of Serbia
Belgrade , , Serbia
Oncomed System
Belgrade , , Serbia
Clinical Center Kragujevac
Kragujevac , , Serbia
Clinical Center Nis
Nis , , Serbia
Institute for Pulmonary Diseases of Vojvodina
Sremska Kamenica , , Serbia
General Hospital Uzice
Uzice , , Serbia
Slovak Research Center- team member, Ambulancia klinickej onkologie
Banka , , Slovakia
Vychodoslovensky onkologicky ustav, a.s.
Kosice , , Slovakia
Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.
Michalovce , , Slovakia
Nemocnica na okraji mesta, n.o.
Partizanske , , Slovakia
Fakultna nemocnica Trnava
Trnava , , Slovakia
Tygerberg Hospital
Cape Town , , South Africa
Exellentis Clinical Trial Consultants
George , , South Africa
Cancercare PE
Johannesburg , , South Africa
The Medical Oncology Centre of Rosebank
Johannesburg , , South Africa
West Rand Oncology Centre
Johannesburg , , South Africa
Wits Clinical Research CMJAH Clinical Trial Site
Johannesburg , , South Africa
Port Elizabeth Oncology Centre-Cancercare
Port Elizabeth , , South Africa
Little Company of Mary Oncology Centre - Mary Potter Cancer Centre
Pretoria , , South Africa
University of Pretoria Medical Oncology
Pretoria , , South Africa
Wilgers Oncology Centre
Pretoria , , South Africa
Chang Gung Medical Foundation Kaohsiung
Kaohsiung City , , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City , , Taiwan
China Medical University Hospital
Taichung City , , Taiwan
Chung Shan Medical University Hospital
Taichung City , , Taiwan
Taichung Veterans General Hospital
Taichung City , , Taiwan
Chung Shan Medical University Hospital
Taichung , , Taiwan
Taipei Medical University Hospital
Taipei , , Taiwan
King Chulalongkorn Memorial Hospital
Bangkok , , Thailand
Phramongkutklao Hospital
Bangkok , , Thailand
Police General Hospital
Bangkok , , Thailand
Rajavithi Hospital
Bangkok , , Thailand
Siriraj Hospital
Bangkok , , Thailand
Vajira Hospital
Bangkok , , Thailand
Prapokklao Hospital
Chanthaburi , , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai , , Thailand
Nakornping Hospital
Chiang Mai , , Thailand
Srinagarind Hospital
Khon Kaen , , Thailand
Lampang Hospital
Lampang , , Thailand
Maharat Nakhon Ratchasima Hospital
Nakhon Ratchasima , , Thailand
HRH Princess Maha Chakri Sirindhorn Medical Centre
Ongkharak , , Thailand
Buddhachinaraj Phitsanulok Hospital
Phitsanulok , , Thailand
Naresuan University Hospital
Phitsanulok , , Thailand
Saraburi Hospital
Saraburi , , Thailand
Songkhlanagarind Hospital
Songkhla , , Thailand
Sunpasitthiprasing Hospital
Ubon Ratchathani , , Thailand
Udon Thani Hospital
Udon Thani , , Thailand
Adana City Hospital
Adana , , Turkey
Baskent University Adana Application and Research Center
Adana , , Turkey
Cukurova University Medical Faculty
Adana , , Turkey
Ankara City Hospital
Ankara , , Turkey
Gazi University Medical Faculty
Ankara , , Turkey
Hacettepe University Medical Faculty
Ankara , , Turkey
Memorial Ankara Hospital
Ankara , , Turkey
Dicle University, Medical faculty
Diyarbakir , , Turkey
Trakya University Medical Faculty
Edirne , , Turkey
Acibadem Atakent Hospital
Istanbul , , Turkey
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul , , Turkey
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul , , Turkey
Medipol University Medical Faculty
Istanbul , , Turkey
Kocaeli Universitesi Tip Fakultesi
Kocaeli , , Turkey
Inonu Uni. Med. Fac.
Malatya , , Turkey
Mersin University Medical Faculty
Mersin , , Turkey
Cần Thơ Oncology Hospital
Cần Thơ , , Vietnam
Pham Ngo Thach Hospital
Ho Chi Minh City , , Vietnam
Huế Central Hospital
Huế , , Vietnam
103 Military Hospital
Hà Nội , , Vietnam
175 Military Hospital
Hà Nội , , Vietnam
Bach Mai Hospital
Hà Nội , , Vietnam
Chợ Rẫy Hospital
Hà Nội , , Vietnam
Hanoi Oncology Hospital
Hà Nội , , Vietnam
HCM Oncology Hospital
Hà Nội , , Vietnam
Ho Chi Minh City University Medical Centre
Hà Nội , , Vietnam
National Lung Hospital
Hà Nội , , Vietnam
Nghe An Oncology Hospital
Hà Nội , , Vietnam
People's Hospital 115
Hà Nội , , Vietnam
Vietnam National Cancer Hospital
Hà Nội , , Vietnam

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

169

Study ID:

NCT04736173

Recruitment Status:

Active, not recruiting

Sponsor:


Arcus Biosciences, Inc.

How clear is this clinincal trial information?

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