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

Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04736173
• Other study ID #: ARC-10
• Secondary ID: 2020-003562-39PH
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 8, 2021
• Est. completion date: July 1, 2027

Study information

• Verified date: June 2024
• Source: Arcus Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 169
• Est. completion date: July 1, 2027
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Have no evidence of progression by neurologic symptoms or signs for at least 4 weeks prior to the first dose.

2. 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.

3. 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non Small Cell Lung Cancer
• Nonsquamous Non Small Cell Lung Cancer
• Squamous Non Small Cell Lung Cancer

Intervention

Drug:
• Domvanalimab
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
• Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
• Carboplatin
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
• Paclitaxel
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
• Pemetrexed
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
• Pembrolizumab
Pembrolizumab is a humanized Immunoglobulin G4 monoclonal antibody targeting the PD-1 receptor

Locations

Country	Name	City	State
Bangladesh	Bangladesh Cancer Society Hospital and Welfare Home	Dhaka
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
France	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
Greece	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
Hong Kong	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
Korea, Republic of	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	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	Samsung Medical Center	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
Malaysia	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
Mexico	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
Peru	Hospital Goyeneche	Arequipa
Peru	Oncosalud	San Borja
Peru	Clinica Ricardo Palma	San Isidro
Philippines	Baguio General Hospital Medical Centre	Baguio City
Philippines	Chong Hua Hospital	Cebu
Philippines	Chung Shan Medical University Hospital	Cebu City
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
Serbia	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
Slovakia	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
South Africa	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
Taiwan	Chang Gung Medical Foundation Kaohsiung	Kaohsiung City
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	China Medical University Hospital	Taichung City
Taiwan	Chung Shan Medical University Hospital	Taichung City
Taiwan	Taichung Veterans General Hospital	Taichung City
Taiwan	Taipei Medical University Hospital	Taipei
Thailand	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
Turkey	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
United States	Gabrail Cancer Center	Canton	Ohio
United States	VA Notheast Ohio Healthcare System	Cleveland	Ohio
United States	Centricity Research	Columbus	Georgia
United States	Centricity Research Columbus Cancer Center	Columbus	Ohio
United States	Affinity Health Hope & Healing Cancer Services	Hinsdale	Illinois
United States	Millennium Research	Houston	Texas
United States	Lumi Research	Kingwood	Texas
United States	Blue Ridge Cancer Center	Roanoke	Virginia
United States	Millennium Reasearch & Clinical Development	Thousand Oaks	California
Vietnam	C?n Tho Oncology Hospital	C?n Tho
Vietnam	103 Military Hospital	Hà N?i
Vietnam	175 Military Hospital	Hà N?i
Vietnam	Bach Mai Hospital	Hà N?i
Vietnam	Ch? R?y Hospital	Hà N?i
Vietnam	Hanoi Oncology Hospital	Hà N?i
Vietnam	HCM Oncology Hospital	Hà N?i
Vietnam	Ho Chi Minh City University Medical Centre	Hà N?i
Vietnam	National Lung Hospital	Hà N?i
Vietnam	Nghe An Oncology Hospital	Hà N?i
Vietnam	People's Hospital 115	Hà N?i
Vietnam	Vietnam National Cancer Hospital	Hà N?i
Vietnam	Pham Ngo Thach Hospital	Ho Chi Minh City
Vietnam	Hu? Central Hospital	Hu?

Sponsors (2)

Lead Sponsor	Collaborator
Arcus Biosciences, Inc.	Gilead Sciences

Countries where clinical trial is conducted

United States,  Vietnam,  Bangladesh,  Brazil,  France,  Greece,  Hong Kong,  Korea, Republic of,  Malaysia,  Mexico,  Peru,  Philippines,  Serbia,  Slovakia,  South Africa,  Taiwan,  Thailand,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Arm D vs. Arm E	From randomization until death from any cause (up to approximately 7 years)
Secondary	Progression-free Survival (PFS)	Arm D vs. Arm E - PFS as assessed by RECIST v1.1 by blinded independent central review	From randomization until death from any cause (up to approximately 7 years)
Secondary	Confirmed Overall Response Rate (ORR)	Arm D vs. Arm E - ORR as assessed by RECIST v1.1 by blinded independent central review	From randomization until death from any cause (up to approximately 7 years)
Secondary	Number of Participants With treatment-emergent adverse events	Arm D vs. Arm E	From randomization until death from any cause (up to approximately 7 years)
Secondary	Time to first symptom deterioration in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score	Arm D vs. Arm E	From randomization until death from any cause (up to approximately 7 years)