Lung Cancer Clinical Trial

Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

Summary

The primary objective of this study is to compare the effect of zimberelimab (ZIM) and domvanalimab (DOM) in combination with chemotherapy relative to pembrolizumab (PEMBRO) in combination with chemotherapy on progression-free survival (PFS) and overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable genomic alteration.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Life expectancy ≥ 3 months.

Pathologically documented NSCLC that meets both of the criteria below:

Have documented evidence of Stage IV NSCLC disease at the time of enrollment (based on American Joint Committee on Cancer (AJCC), Eighth Edition).
Have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations.
Have no actionable genomic alterations such as ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), RET mutations, or other driver oncogenes with approved frontline therapies.
Have not received prior systemic treatment for metastatic NSCLC.
Measurable disease per RECIST v1.1 criteria by investigator assessment.
Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
Have adequate organ functions.

Key Exclusion Criteria:

Have mixed small-cell lung cancer (SCLC) and NSCLC histology.
Positive serum pregnancy test or individuals who are breastfeeding or have plans to breastfeed during the study period.
Received prior treatment with any anti-PD-1, anti-PD-L1, or any other antibody targeting an immune checkpoint.
Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
Have an active second malignancy or have had an active second malignancy within 3 years prior to enrollment.
Have an active autoimmune disease that required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
Are receiving chronic systemic steroids.
Have significant third-space fluid retention.
Have untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.
Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Has had an allogenic tissue/solid organ transplant.
Have received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

720

Study ID:

NCT05502237

Recruitment Status:

Recruiting

Sponsor:

Gilead Sciences

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There are 195 Locations for this study

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Palo Verde Hematology Oncology Ltd
Glendale Arizona, 85304, United States
California Cancer Associates for Research and Excellence
San Marcos California, 92069, United States
Texas Oncology
Santa Barbara California, 93105, United States
Innovative Clinical Research Institute
Whittier California, 90606, United States
Eastern CT Hematology and Oncology Associates
Norwich Connecticut, 06360, United States
Lake City Cancer Care
Lake City Florida, 32024, United States
Florida Cancer Specialists
Sarasota Florida, 34232, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Peachtree Hematology Oncology Consultants
Atlanta Georgia, 30318, United States
Illinois Cancer Care
Peoria Illinois, 61615, United States
Messino Cancer Centers
Asheville North Carolina, 28806, United States
Oncology Hematology Care, Inc.
Cincinnati Ohio, 45242, United States
Hematology & Oncology Associates
Eugene Oregon, 97401, United States
AHN Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
Arlington Cancer Center
Arlington Texas, 76012, United States
Texas Oncology - Austin
Austin Texas, 78745, United States
Texas Oncology
Dallas Texas, 75246, United States
Texas Oncology- Denison
Sherman Texas, 75090, United States
US Oncology Investigational Products Center (IPC)
Arlington Virginia, 22205, United States
Oncology and Hematology Associates of Southwest Virginia, Inc
Blacksburg Virginia, 24060, United States
Northwest Cancer Specialists, PC
Vancouver Washington, 98684, United States
Investigaciones CORI S.R.L.
Capital , F5300, Argentina
Centro Médico Privado Centro de Especialidades Médicas Ambulatorias e Investigación Clínica
Cardoba , X5008, Argentina
Centro Medico Barrio Parque
Ciudad Autanoma Buenos Aires , 1426, Argentina
Sanatorio Allende
Cordoba , 5000, Argentina
Sanatorio Britanico de Rosario
Rosario , 2000, Argentina
Sanatorio Parque de Rosario
Rosario , S2000, Argentina
Hospital Provincial del Centenario
Rosario , S2002, Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario , S2013, Argentina
CAIPO - Centro para la Atención Integral del Paciente Oncológico
San Miguel de Tucumán , 4000, Argentina
Clínica Viedma
Viedma , 8500, Argentina
Klinikum Klagenfurt am Woerthersee
Klagenfurt Am Woerthersee , , Austria
Ordensklinikum Linz GmbH, Elisabethinen
Linz , 4020, Austria
Klinikum Wels-Grieskirchen
Wels , 4600, Austria
Krankenhaus Nord - Klinik Floridsdorf
Wien , A-114, Austria
Algemeen Ziekenhuis Sint-Lucas
Aalst , 9300, Belgium
Grand Hopital de Charleroi asbl (GHdC)
Charleroi , 6000, Belgium
AZ Sint-Maarten
Mechelen , 2800, Belgium
CHU UCL Namur / Site Sainte Elisabeth
Namur , 5000, Belgium
Cenantron Centro Avançado de Tratamento Oncologico Ltda
Belo Horizonte , 30130, Brazil
Hospital Evangelico de Cachoeiro de Itapemirim
Cachoeiro De Itapemirim , 29308, Brazil
Fundacao Universidade De Caxias Do Sul - FUCS/RS
Caxias Do Sul , 95070, Brazil
Instituto do Câncer do Ceará - ICC
Fortaleza , 60430, Brazil
Oncosite - Centro de Pesquisa Clinica em Oncologia LTDA
Ijui , 98700, Brazil
Centro Des Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho
Jau , 17210, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre , 90020, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre , 90035, Brazil
Hospital São Lucas da PUCRS
Porto Alegre , 90610, Brazil
Hospital Ana Nery Santa Cruz do Sul
Santa Cruz Do Sul , 96810, Brazil
Instituto Brasiliero de Controle do Cancer IBCC
Sao Paulo , 03102, Brazil
Centre Integre de sante et de services sociaux de la Monteregie Centre
Greenfield Park , J4V 2, Canada
Moncton Hospital
Moncton , E1C 6, Canada
CISSS des Laurentides
Quebec , J7Z 2, Canada
Centre de santé et services sociaux de Rimouski-Neigette
Rimouski , G5L5T, Canada
BC Cancer - Victoria
Victoria , V8R 6, Canada
Clinica Alemana de Santiago
Las Condes , 75500, Chile
Orlandioncologia
Providencia , 75000, Chile
Oncovida- Santiago
Providencia , 75100, Chile
Clinica Puerto Montt
Puerto Montt , 55002, Chile
Biocinetic
Santiago , 83311, Chile
James Lind Centro de Investigacion del Cancer
Temuco , 48008, Chile
Oncocentro APYS
Vina del Mar , 25206, Chile
West China Hospital Sichuan University
Chengdu , 61004, China
Deyang People's Hospital
Deyang , 61800, China
Shanghai Pulmonary Hospital
Shanghai , 20043, China
Cancer Hospital of Shantou University Medical College
Shantou , 0754-, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan , 43002, China
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang , 45310, China
Ambroise-Pare Hospital, Assistance Publique - Hopitaux de Paris
Boulogne-Billancourt , 92100, France
CHU de Caen
Caen , 14000, France
Clinique Victor Hugo, Centre de Cancerologie de la Sarthe
Le Mans , 72000, France
Hopital Nord
Marseille , 13005, France
Institut de Cancer de Montpellier (ICM) - Val d'Aurelle
Montpellier , 34928, France
Centre Antoine Lacassagne
Nice , 6189, France
Institut de cancerologie de l'ouest (ICO)
Saint-Herblain , 44805, France
Hopital d'Instruction des Armees (HIA) Begin
Saint-Mandé , 94160, France
Centre Hospitalier de Saint-Quentin
Saint-Quentin , 2100, France
Institut de Cancerologie Strasbourg Europe (ICANS)
Strasbourg , 67033, France
Hôpital Foch
Suresnes , 92150, France
CHI de Toulon la Seyne-sur-Mer Hopital Sainte Musse
Toulon cedex , 83056, France
Augusta-Kranken-Anstalt gGmbh Klinik für Hämatologie Onkologie und Palliativmedizin
Bochum , 44791, Germany
Klinikum Chemnitz gGmbH
Chemnitz , 9116, Germany
Universitatsklinikum Essen / Westdeutsches Tumorzentrum, Innere Klinik (Tumorforschung)
Essen , 45122, Germany
Universitätsklinikum Freiburg, Klinik für Innere Medizin I Hämatologie, Onkologie und Stammzelltransplantation
Freiburg , 79106, Germany
LungenClinic Grosshansdorf
Grosshansdorf , 22927, Germany
Krankenhaus Martha-Maria Halle Dölau
Halle , 06120, Germany
Asklepios Kliniken Hamburg
Hamburg , 21075, Germany
Katholisches Marienkrankenhaus gGmbH
Hamburg , 22087, Germany
Lungenklinik Hemer, Zentrum fur Pneumologie and Thoraxchirurgie
Hemer , 58675, Germany
Vincentius-Diakonissen-Kliniken gAG, St. Vincentius-Kliniken, Medizinische Klinik 2
Karlsruhe , 76137, Germany
Klinikum Kassel
Kassel , 34125, Germany
Kliniken der Stadt Köln ggmbh, Krankenhaus Koln-Merheim/Lungenklinik
Köln , 51109, Germany
Universitatsklinikum Schleswig-Holstein
Lubeck , 23538, Germany
Johannes Wesling Klinikum Minden
Minden , 32429, Germany
Munchen Klinik Bogenhausen, Klinik fur Pneumologie und Pneumologische Onkologie
Munchen , 81925, Germany
Sana Klinikum Offenbach GmbH, Medizinische Klinik IV, Hämatologie und Internistische Onkologie
Offenbach , 63069, Germany
Queen Elizabeth Hospital
Hong Kong , 99907, Hong Kong
Queen Mary Hospital
Hong Kong , , Hong Kong
Prince of Wales Hospital
New Territories , , Hong Kong
Soroka University Medical Center, Itzchak Rager Blvd.
Beer Seva , 84101, Israel
Shaare Zedek Medical Center
Jerusalem , 91031, Israel
Oncology Institute, Galilee Medical Center, Route 89 Nahariya-Cabri
Nahariya , , Israel
Rabin Medical Center
Petah Tiqva , 49100, Israel
Kaplan Medical Center
Rehovot , 76100, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Azienda Ospedaliera San Giuseppe Moscati
Avellino , , Italy
IRCCS Fondazoine del Piemonte per l'Oncologia
Candiolo , 10060, Italy
Azienda Socio Sanitaria Territoriale di Cremona
Cremona , 26100, Italy
Ospedale Policlinico San Martino
Genova , 16132, Italy
Ospedale San Raffaele
Milano , 20132, Italy
Azienda Ospedaliero Universitaria di Modena
Modena , 41124, Italy
AORN Cardarelli
Naples , 80131, Italy
Azienda Ospedaliera dei Colli
Napoli , 80131, Italy
IRCCS Policlinico S. Matteo, Dipartimento Oncologia Ematologia-Oncologia Medica
Pavia , 27100, Italy
Azienda Sanitaria Territoriale Pesaro e Urbino (AST)
Pesaro , 61122, Italy
Ospedale Guglielmo da Saliceto AUSL di Piacenza
Piacenza , 29100, Italy
Centro di Riferimento Oncologico
Pordenone , 33081, Italy
Regina Elena Institute for Cancer Research
Rome , 00144, Italy
ASST Bergamo Ovest- ospedale di Treviglio
Treviglio , 24047, Italy
National Cancer Center Hospital East
Chiba , 277-0, Japan
National Hospital Organization Shikoku Cancer Center
Ehime , 791-0, Japan
Kyushu University Hospital
Fukuoka , 812-8, Japan
Kurume University Hospital
Fukuoka , 830-0, Japan
National Hospital Organization Himeji Medical Center
Hyogo , 670-8, Japan
Hyogo Cancer Center
Hyogo , 673-8, Japan
Kanazawa University Hospital
Ishikawa , 920-8, Japan
Kanagawa Cancer Center
Kanagawa , 241-0, Japan
Sendai Kousei Hospital
Miyagi , 980-0, Japan
Niigata Cancer Center Hospital
Niigata , 951-8, Japan
Osaka Metropolitan University Hospital
Osaka , 545-8, Japan
Osaka Medical and Pharmaceutical University Hospital
Osaka , 569-8, Japan
Kindai University Hospital
Osaka , 589-8, Japan
National Hospital Organization Kinki Chuo Chest Medical Center
Osaka , 591-8, Japan
Saitama Medical University
Saitama , 350-1, Japan
SMG - SNU Boramae Medical Center
Dongjak-Gu , 07061, Korea, Republic of
Samsung Medical Center
Gangnam-Gu , 6351, Korea, Republic of
National Cancer Center
Goyang , 41076, Korea, Republic of
Chungbuk National University Hospital
Heungdeok-Gu , 361-7, Korea, Republic of
Inha University Hospital
Incheon , 22332, Korea, Republic of
Gachon University Gil Medical Center
Inchon , 21565, Korea, Republic of
Kosin University Gospel Hospital
Seo-gu , 49267, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
Ajou University Hospital
Suwon-si , 16499, Korea, Republic of
The Catholic University of Korea, Saint Vincent's Hospital
Suwon , 16247, Korea, Republic of
Health Pharma Professional Research S.A. de C.V.
Mexico , 3100, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Mitras Centro , 64460, Mexico
Oaxaca Site Management Organization
Oaxaca , 68000, Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca , 68020, Mexico
Clinical Medical Research SC.
Orizaba Centro , 94300, Mexico
Clinica Integral Internacional de Oncologia S de RL de CV
Puebla , 72530, Mexico
FAICIC Clínical Research
Veracruz , 91900, Mexico
Amphia Ziekenhuis
Breda , 4818 , Netherlands
Ziekenhuis Gelderse Vallei
Ede , 6716 , Netherlands
Universitair Medisch Centrum Groningen
Groningen , 9713 , Netherlands
Ziekenhuis St Jansdal
Harderwijk , 3844 , Netherlands
TweeSteden Ziekenhuis
Tilburg , , Netherlands
Hospital Prof. Doutor Fernando Fonseca
Amadora , 27202, Portugal
Instituto Português de Oncologia de Lisboa Francisco Gentil
Lisboa , 1089, Portugal
Fundacao Champalimaud
Lisboa , 1400-, Portugal
Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente
Lisboa , , Portugal
Hospital Beatriz Angelo. Hospital de Loures.
Lisbon , 2674-, Portugal
Centro Hospitalar Universitario Sao Joao, EPE
Porto , 4202-, Portugal
Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA
Senhora da Hora , 4464-, Portugal
Raffles Hospital
Singapore , 18877, Singapore
Tang Tock Seng Hospital
Singapore , 30843, Singapore
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital de la Santa Creu i de Sant Pau
Barcelona , 08041, Spain
Hospital Universitari Dexeus (USP Institut Universitari Dexeus/Hospital Universitari Quiron Dexeus)
Barcelona , 8028, Spain
Hospital Universitari Vall D'Hebron
Barcelona , 8035, Spain
Hospital Parc Tauli
Barcelona , 8208, Spain
Hospital Universitario Reina Sofia
Cordoba , 14004, Spain
Hospital Doctor Josep Trueta
Girona , 17007, Spain
Hospital Universitario de Jaen
Jaen , 23007, Spain
Hospital Universitario de Canarias
Las Palmas de G.C. , 35016, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28020, Spain
Clinica Universidad de Navarra
Madrid , 28027, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda , 28222, Spain
Hospital Sant Joan de Reus
Reus , 43204, Spain
Hospital Regional Universitario de Malaga
Rincon de la Victoria , 29011, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain
Hospital Universitario Virgen del Rocio
Seville , 41014, Spain
Instituto Valenciano De Oncologia (IVO)
Valencia , 46009, Spain
Hospital Universitari i Politecnic La Fe
Valencia , 46015, Spain
Hospital Vithas Valencia 9 de Octubre
Valencia , 46015, Spain
Changhua Christian Hospital
Changhua City , 500-0, Taiwan
E-DA Hospital
Kaohsiung City , 824, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , 807, Taiwan
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung , 83301, Taiwan
National Cheng Kung University Hospital
Tainan , 70403, Taiwan
Chi Mei Hospital, Liouying
Tainan , , Taiwan
National Taiwan University Hospital
Taipei City , 100, Taiwan
Taipei Veterans General Hospital
Taipei , 10002, Taiwan
Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical Foundation
Taoyuan City , 33305, Taiwan
Ankara Bilkent Sehir Hastanesi
Ankara , 06550, Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara , 6200, Turkey
Trakya University Faculty of Medicine
Edirne , 22030, Turkey
Istanbul University Cerrahpasa Medical Faculty Hospital
Fatih , 34098, Turkey
Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi
Istanbul , 34093, Turkey
Medipol Mega University Hospital
Istanbul , , Turkey
Acibadem Mehmet Ali Aydinlar Universitesi Atakent Hastanesi
Kaakaekmece , 34303, Turkey
Turgut Ozal Medical Faculty
Malatya , 44300, Turkey
Colchester General Hospital
Colchester , CO4 5, United Kingdom
St Bartholomew's Hospital, Barts Health NHS Trust
London , EC1A , United Kingdom
University Hospital Southampton Nhs Foundation Trust
Southampton , SO16 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

720

Study ID:

NCT05502237

Recruitment Status:

Recruiting

Sponsor:


Gilead Sciences

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