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)
Non Small Cell Lung Cancer, Nonsquamous Non Small Cell Lung Cancer, Squamous Non Small Cell Lung Cancer
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
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
Active Comparator
Experimental
Active Comparator
Experimental
Experimental
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)
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.