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 known genomic alterations in ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), RET mutations, or other actionable driver oncogenes with approved therapies (actionable genomic alteration).
Have not received prior systemic treatment for metastatic NSCLC.
Measurable disease by CT or MRI as 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 (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
Are receiving chronic systemic steroids.
Have significant third-space fluid retention
Have known active 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

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 96 Locations for this study

See Locations Near You

Palo Verde Hematology Oncology Ltd
Glendale Arizona, 85304, 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
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
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
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
Instituto do Câncer do Ceará - ICC
Fortaleza , 60430, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre , 90020, Brazil
Hospital São Lucas da PUCRS
Porto Alegre , 90610, Brazil
Instituto Brasiliero de Controle do Cancer IBCC
Sao Paulo , 03102, Brazil
Centre de santé et services sociaux de Rimouski-Neigette
Rimouski , G5L5T, Canada
CISSS des Laurentides
Saint-Jérôme , J7Z 5, Canada
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
Klinikum Chemnitz gGmbH
Chemnitz , 9116, 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
Vincentius-Diakonissen-Kliniken gAG, St. Vincentius-Kliniken, Medizinische Klinik 2
Karlsruhe , 76137, Germany
Klinikum Kassel
Kassel , 34125, Germany
Universitatsklinikum Schleswig-Holstein
Lubeck , 23538, Germany
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
Ospedale Policlinico San Martino
Genova , 16132, Italy
Ospedale San Raffaele
Milano , 20132, Italy
Azienda Ospedaliera dei Colli
Napoli , 80131, Italy
Azienda Sanitaria Territoriale Pesaro e Urbino (AST)
Pesaro , 61122, Italy
Ospedale Guglielmo da Saliceto AUSL di Piacenza
Piacenza , 29100, Italy
Regina Elena Institute for Cancer Research
Rome , 00144, Italy
ASST Bergamo Ovest- ospedale di Treviglio
Treviglio , 24047, Italy
Amphia Ziekenhuis
Breda , 4818 , Netherlands
Ziekenhuis Gelderse Vallei
Ede , 6716 , Netherlands
Ziekenhuis St Jansdal
Harderwijk , 3844 , Netherlands
TweeSteden Ziekenhuis
Tilburg , , Netherlands
Hospital Prof. Doutor Fernando Fonseca
Amadora , 27202, Portugal
Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente
Lisboa , , 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 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 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
Taipei Veterans General Hospital
Taipei , 10002, Taiwan
Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical Foundation
Taoyuan City , 33305, Taiwan

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

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.