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Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer (STAR-121)

Primary Purpose

Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Zimberelimab
Domvanalimab
Pembrolizumab
Carboplatin
Cisplatin
Paclitaxel
Nab-paclitaxel
Pemetrexed
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Palo Verde Hematology Oncology LtdRecruiting
  • California Cancer Associates for Research and ExcellenceRecruiting
  • Texas OncologyRecruiting
  • Innovative Clinical Research InstituteRecruiting
  • Eastern CT Hematology and Oncology AssociatesRecruiting
  • Lake City Cancer CareRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Moffitt Cancer CenterRecruiting
  • Peachtree Hematology Oncology ConsultantsRecruiting
  • Illinois Cancer CareRecruiting
  • Messino Cancer CentersRecruiting
  • Oncology Hematology Care, Inc.Recruiting
  • Hematology & Oncology AssociatesRecruiting
  • AHN Allegheny General HospitalRecruiting
  • Arlington Cancer CenterRecruiting
  • Texas Oncology - AustinRecruiting
  • Texas OncologyRecruiting
  • Texas Oncology- DenisonRecruiting
  • US Oncology Investigational Products Center (IPC)Recruiting
  • Oncology and Hematology Associates of Southwest Virginia, IncRecruiting
  • Northwest Cancer Specialists, PCRecruiting
  • Investigaciones CORI S.R.L.Recruiting
  • Centro Médico Privado Centro de Especialidades Médicas Ambulatorias e Investigación ClínicaRecruiting
  • Centro Medico Barrio ParqueRecruiting
  • Sanatorio AllendeRecruiting
  • Sanatorio Britanico de RosarioRecruiting
  • Sanatorio Parque de RosarioRecruiting
  • Hospital Provincial del CentenarioRecruiting
  • Instituto Medico de la Fundacion Estudios ClinicosRecruiting
  • CAIPO - Centro para la Atención Integral del Paciente OncológicoRecruiting
  • Clínica ViedmaRecruiting
  • Klinikum Klagenfurt am WoertherseeRecruiting
  • Ordensklinikum Linz GmbH, ElisabethinenRecruiting
  • Klinikum Wels-GrieskirchenRecruiting
  • Krankenhaus Nord - Klinik FloridsdorfRecruiting
  • Algemeen Ziekenhuis Sint-LucasRecruiting
  • Grand Hopital de Charleroi asbl (GHdC)Recruiting
  • AZ Sint-MaartenRecruiting
  • CHU UCL Namur / Site Sainte ElisabethRecruiting
  • Cenantron Centro Avançado de Tratamento Oncologico LtdaRecruiting
  • Instituto do Câncer do Ceará - ICCRecruiting
  • Oncosite - Centro de Pesquisa Clinica em Oncologia LTDARecruiting
  • Centro Des Pesquisas Clinicas da Fundacao Doutor Amaral CarvalhoRecruiting
  • Irmandade da Santa Casa de Misericordia de Porto AlegreRecruiting
  • Hospital São Lucas da PUCRSRecruiting
  • Hospital Ana Nery Santa Cruz do SulRecruiting
  • Instituto Brasiliero de Controle do Cancer IBCCRecruiting
  • Centre de santé et services sociaux de Rimouski-NeigetteRecruiting
  • CISSS des LaurentidesRecruiting
  • Clinica Alemana de SantiagoRecruiting
  • OrlandioncologiaRecruiting
  • Oncovida- SantiagoRecruiting
  • Clinica Puerto MonttRecruiting
  • BiocineticRecruiting
  • James Lind Centro de Investigacion del CancerRecruiting
  • Oncocentro APYSRecruiting
  • Klinikum Chemnitz gGmbHRecruiting
  • LungenClinic GrosshansdorfRecruiting
  • Krankenhaus Martha-Maria Halle DölauRecruiting
  • Asklepios Kliniken HamburgRecruiting
  • Katholisches Marienkrankenhaus gGmbHRecruiting
  • Lungenklinik Hemer, Zentrum fur Pneumologie and ThoraxchirurgieRecruiting
  • Vincentius-Diakonissen-Kliniken gAG, St. Vincentius-Kliniken, Medizinische Klinik 2Recruiting
  • Klinikum KasselRecruiting
  • Kliniken der Stadt Köln ggmbh, Krankenhaus Koln-Merheim/LungenklinikRecruiting
  • Universitatsklinikum Schleswig-HolsteinRecruiting
  • Johannes Wesling Klinikum MindenRecruiting
  • Queen Elizabeth HospitalRecruiting
  • Queen Mary HospitalRecruiting
  • Prince of Wales HospitalRecruiting
  • Soroka University Medical Center, Itzchak Rager Blvd.Recruiting
  • Shaare Zedek Medical CenterRecruiting
  • Oncology Institute, Galilee Medical Center, Route 89 Nahariya-CabriRecruiting
  • Rabin Medical CenterRecruiting
  • Kaplan Medical CenterRecruiting
  • Tel-Aviv Sourasky Medical CenterRecruiting
  • Azienda Ospedaliera San Giuseppe MoscatiRecruiting
  • IRCCS Fondazoine del Piemonte per l'OncologiaRecruiting
  • Azienda Socio Sanitaria Territoriale di CremonaRecruiting
  • Ospedale Policlinico San MartinoRecruiting
  • Ospedale San RaffaeleRecruiting
  • AORN CardarelliRecruiting
  • Azienda Ospedaliera dei ColliRecruiting
  • IRCCS Policlinico S. Matteo, Dipartimento Oncologia Ematologia-Oncologia MedicaRecruiting
  • Azienda Sanitaria Territoriale Pesaro e Urbino (AST)Recruiting
  • Ospedale Guglielmo da Saliceto AUSL di PiacenzaRecruiting
  • Regina Elena Institute for Cancer ResearchRecruiting
  • ASST Bergamo Ovest- ospedale di TreviglioRecruiting
  • Amphia ZiekenhuisRecruiting
  • Ziekenhuis Gelderse ValleiRecruiting
  • Ziekenhuis St JansdalRecruiting
  • TweeSteden ZiekenhuisRecruiting
  • Hospital Prof. Doutor Fernando FonsecaRecruiting
  • Fundacao ChampalimaudRecruiting
  • Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido ValenteRecruiting
  • Centro Hospitalar Universitario Sao Joao, EPERecruiting
  • Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SARecruiting
  • Raffles HospitalRecruiting
  • Tang Tock Seng HospitalRecruiting
  • Hospital Clinic de BarcelonaRecruiting
  • Hospital de la Santa Creu i de Sant PauRecruiting
  • Hospital Universitari Dexeus (USP Institut Universitari Dexeus/Hospital Universitari Quiron Dexeus)Recruiting
  • Hospital Universitari Vall D'HebronRecruiting
  • Hospital Parc TauliRecruiting
  • Hospital Universitario Reina SofiaRecruiting
  • Hospital Doctor Josep TruetaRecruiting
  • Hospital Universitario de JaenRecruiting
  • Hospital Universitario Fundacion Jimenez DiazRecruiting
  • Clinica Universidad de NavarraRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Universitario Puerta de Hierro de MajadahondaRecruiting
  • Hospital Sant Joan de ReusRecruiting
  • Hospital Regional Universitario de MalagaRecruiting
  • Hospital Universitario Virgen MacarenaRecruiting
  • Hospital Universitario Virgen del RocioRecruiting
  • Instituto Valenciano De Oncologia (IVO)Recruiting
  • Hospital Universitari i Politecnic La FeRecruiting
  • Hospital Vithas Valencia 9 de OctubreRecruiting
  • Changhua Christian HospitalRecruiting
  • E-DA HospitalRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • Chang Gung Memorial Hospital KaohsiungRecruiting
  • National Cheng Kung University HospitalRecruiting
  • Chi Mei Hospital, LiouyingRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical FoundationRecruiting
  • Istanbul University Cerrahpasa Medical Faculty HospitalRecruiting
  • Medipol Mega University HospitalRecruiting
  • Turgut Ozal Medical FacultyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy

Pembrolizumab (PEMBRO) + Chemotherapy

Zimberelimab (ZIM) + Chemotherapy

Arm Description

Participants will receive ZIM 360 mg + DOM 1200 mg (up to 35 doses) with chemotherapy every 3 weeks (Q3W) on Day 1 of each 21-day cycle. Choice of chemotherapy is dependent on histology. Participants with nonsquamous histology will receive cisplatin 75 mg/m^2 or carboplatin area under the concentration versus time curve (AUC)5 + pemetrexed 500 mg/m^2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m^2 Q3W until disease progression or intolerable toxicities. Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m^2 Q3W or nab-paclitaxel 100 mg/m^2 weekly (QW) for first 4 cycles.

Participants will receive PEMBRO 200 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle. Choice of chemotherapy is dependent on histology. Participants with nonsquamous histology will receive cisplatin 75 mg/m^2 or carboplatin AUC 5 + pemetrexed 500 mg/m^2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m^2 Q3W until disease progression or intolerable toxicities. Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m^2 Q3W or nab-paclitaxel 100 mg/m^2 weekly (QW) for first 4 cycles.

Participants will receive ZIM 360 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle. Choice of chemotherapy is dependent on histology. Participants with nonsquamous histology will receive cisplatin 75 mg/m^2 or carboplatin AUC 5 + pemetrexed 500 mg/m^2 Q3W for first 4 cycles After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m^2 Q3W until disease progression or intolerable toxicities. Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m^2 Q3W or nab-paclitaxel 100 mg/m^2 weekly (QW) for first 4 cycles.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PFS is defined as the time from the date of randomization until disease progression (PD) or death from any cause, whichever comes first.
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause.

Secondary Outcome Measures

Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
ORR is defined as the proportion of participants who have achieved a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later.
Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
DOR is defined as the time from the first response (CR or PR), to the first documented PD or death from any cause, whichever comes first.
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Time to First Symptom Deterioration in Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Total Score
The NSCLC-SAQ is a patient reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No <symptom> At All" to "Very severe <symptom>" or from "Never to Always," corresponding to a score of 0 to 4. The sum of all 5 domain scores will be computed, if any scores are missing, a total score will not be computed. The total score ranges between 0 and 20 with higher scores indicating more severe symptoms.

Full Information

First Posted
August 12, 2022
Last Updated
October 13, 2023
Sponsor
Gilead Sciences
Collaborators
Arcus Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05502237
Brief Title
Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer
Acronym
STAR-121
Official Title
A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2022 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
Collaborators
Arcus Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy
Arm Type
Experimental
Arm Description
Participants will receive ZIM 360 mg + DOM 1200 mg (up to 35 doses) with chemotherapy every 3 weeks (Q3W) on Day 1 of each 21-day cycle. Choice of chemotherapy is dependent on histology. Participants with nonsquamous histology will receive cisplatin 75 mg/m^2 or carboplatin area under the concentration versus time curve (AUC)5 + pemetrexed 500 mg/m^2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m^2 Q3W until disease progression or intolerable toxicities. Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m^2 Q3W or nab-paclitaxel 100 mg/m^2 weekly (QW) for first 4 cycles.
Arm Title
Pembrolizumab (PEMBRO) + Chemotherapy
Arm Type
Active Comparator
Arm Description
Participants will receive PEMBRO 200 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle. Choice of chemotherapy is dependent on histology. Participants with nonsquamous histology will receive cisplatin 75 mg/m^2 or carboplatin AUC 5 + pemetrexed 500 mg/m^2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m^2 Q3W until disease progression or intolerable toxicities. Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m^2 Q3W or nab-paclitaxel 100 mg/m^2 weekly (QW) for first 4 cycles.
Arm Title
Zimberelimab (ZIM) + Chemotherapy
Arm Type
Experimental
Arm Description
Participants will receive ZIM 360 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle. Choice of chemotherapy is dependent on histology. Participants with nonsquamous histology will receive cisplatin 75 mg/m^2 or carboplatin AUC 5 + pemetrexed 500 mg/m^2 Q3W for first 4 cycles After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m^2 Q3W until disease progression or intolerable toxicities. Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m^2 Q3W or nab-paclitaxel 100 mg/m^2 weekly (QW) for first 4 cycles.
Intervention Type
Drug
Intervention Name(s)
Zimberelimab
Other Intervention Name(s)
GS-0122, AB122
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Domvanalimab
Other Intervention Name(s)
GS-0154, AB154
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda®
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Administered intravenously
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Description
PFS is defined as the time from the date of randomization until disease progression (PD) or death from any cause, whichever comes first.
Time Frame
Up to 31 months
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization to the date of death from any cause.
Time Frame
Up to 58 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
Description
ORR is defined as the proportion of participants who have achieved a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later.
Time Frame
Up to 58 Months
Title
Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
Description
DOR is defined as the time from the first response (CR or PR), to the first documented PD or death from any cause, whichever comes first.
Time Frame
Up to 58 Months
Title
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame
First dose date up to 58 months plus 30 days
Title
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Time Frame
First dose date up to 58 months plus 30 days
Title
Time to First Symptom Deterioration in Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Total Score
Description
The NSCLC-SAQ is a patient reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No <symptom> At All" to "Very severe <symptom>" or from "Never to Always," corresponding to a score of 0 to 4. The sum of all 5 domain scores will be computed, if any scores are missing, a total score will not be computed. The total score ranges between 0 and 20 with higher scores indicating more severe symptoms.
Time Frame
Baseline, Up to 58 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilead Clinical Study Information Center
Phone
1-833-445-3230 (GILEAD-0)
Email
GileadClinicalTrials@gilead.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Palo Verde Hematology Oncology Ltd
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85304
Country
United States
Individual Site Status
Recruiting
Facility Name
California Cancer Associates for Research and Excellence
City
San Marcos
State/Province
California
ZIP/Postal Code
92069
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Individual Site Status
Recruiting
Facility Name
Innovative Clinical Research Institute
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Individual Site Status
Recruiting
Facility Name
Eastern CT Hematology and Oncology Associates
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Individual Site Status
Recruiting
Facility Name
Lake City Cancer Care
City
Lake City
State/Province
Florida
ZIP/Postal Code
32024
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Individual Site Status
Recruiting
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Peachtree Hematology Oncology Consultants
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Recruiting
Facility Name
Illinois Cancer Care
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Individual Site Status
Recruiting
Facility Name
Messino Cancer Centers
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Name
Hematology & Oncology Associates
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Name
AHN Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology- Denison
City
Sherman
State/Province
Texas
ZIP/Postal Code
75090
Country
United States
Individual Site Status
Recruiting
Facility Name
US Oncology Investigational Products Center (IPC)
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Cancer Specialists, PC
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigaciones CORI S.R.L.
City
Capital
ZIP/Postal Code
F5300COE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Médico Privado Centro de Especialidades Médicas Ambulatorias e Investigación Clínica
City
Cardoba
ZIP/Postal Code
X5008HHW
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Medico Barrio Parque
City
Ciudad Autanoma Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sanatorio Allende
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sanatorio Britanico de Rosario
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sanatorio Parque de Rosario
City
Rosario
ZIP/Postal Code
S2000DSV
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Provincial del Centenario
City
Rosario
ZIP/Postal Code
S2002KDS
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto Medico de la Fundacion Estudios Clinicos
City
Rosario
ZIP/Postal Code
S2013DTC
Country
Argentina
Individual Site Status
Recruiting
Facility Name
CAIPO - Centro para la Atención Integral del Paciente Oncológico
City
San Miguel de Tucumán
ZIP/Postal Code
4000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Clínica Viedma
City
Viedma
ZIP/Postal Code
8500
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Klinikum Klagenfurt am Woerthersee
City
Klagenfurt Am Woerthersee
Country
Austria
Individual Site Status
Recruiting
Facility Name
Ordensklinikum Linz GmbH, Elisabethinen
City
Linz
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Klinikum Wels-Grieskirchen
City
Wels
ZIP/Postal Code
4600
Country
Austria
Individual Site Status
Recruiting
Facility Name
Krankenhaus Nord - Klinik Floridsdorf
City
Wien
ZIP/Postal Code
A-1140
Country
Austria
Individual Site Status
Recruiting
Facility Name
Algemeen Ziekenhuis Sint-Lucas
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Grand Hopital de Charleroi asbl (GHdC)
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Sint-Maarten
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU UCL Namur / Site Sainte Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Cenantron Centro Avançado de Tratamento Oncologico Ltda
City
Belo Horizonte
ZIP/Postal Code
30130-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto do Câncer do Ceará - ICC
City
Fortaleza
ZIP/Postal Code
60430-230
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Oncosite - Centro de Pesquisa Clinica em Oncologia LTDA
City
Ijui
ZIP/Postal Code
98700-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro Des Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho
City
Jau
ZIP/Postal Code
17210080
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Irmandade da Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital São Lucas da PUCRS
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Ana Nery Santa Cruz do Sul
City
Santa Cruz Do Sul
ZIP/Postal Code
96810-110
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Brasiliero de Controle do Cancer IBCC
City
Sao Paulo
ZIP/Postal Code
03102002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centre de santé et services sociaux de Rimouski-Neigette
City
Rimouski
ZIP/Postal Code
G5L5T1
Country
Canada
Individual Site Status
Recruiting
Facility Name
CISSS des Laurentides
City
Saint-Jérôme
ZIP/Postal Code
J7Z 5T3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinica Alemana de Santiago
City
Las Condes
ZIP/Postal Code
7550000
Country
Chile
Individual Site Status
Recruiting
Facility Name
Orlandioncologia
City
Providencia
ZIP/Postal Code
7500006
Country
Chile
Individual Site Status
Recruiting
Facility Name
Oncovida- Santiago
City
Providencia
ZIP/Postal Code
7510035
Country
Chile
Individual Site Status
Recruiting
Facility Name
Clinica Puerto Montt
City
Puerto Montt
ZIP/Postal Code
5500243
Country
Chile
Individual Site Status
Recruiting
Facility Name
Biocinetic
City
Santiago
ZIP/Postal Code
8331143
Country
Chile
Individual Site Status
Recruiting
Facility Name
James Lind Centro de Investigacion del Cancer
City
Temuco
ZIP/Postal Code
4800827
Country
Chile
Individual Site Status
Recruiting
Facility Name
Oncocentro APYS
City
Vina del Mar
ZIP/Postal Code
2520612
Country
Chile
Individual Site Status
Recruiting
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
9116
Country
Germany
Individual Site Status
Recruiting
Facility Name
LungenClinic Grosshansdorf
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Individual Site Status
Recruiting
Facility Name
Krankenhaus Martha-Maria Halle Dölau
City
Halle
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Asklepios Kliniken Hamburg
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Katholisches Marienkrankenhaus gGmbH
City
Hamburg
ZIP/Postal Code
22087
Country
Germany
Individual Site Status
Recruiting
Facility Name
Lungenklinik Hemer, Zentrum fur Pneumologie and Thoraxchirurgie
City
Hemer
ZIP/Postal Code
58675
Country
Germany
Individual Site Status
Recruiting
Facility Name
Vincentius-Diakonissen-Kliniken gAG, St. Vincentius-Kliniken, Medizinische Klinik 2
City
Karlsruhe
ZIP/Postal Code
76137
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Kassel
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Individual Site Status
Recruiting
Facility Name
Kliniken der Stadt Köln ggmbh, Krankenhaus Koln-Merheim/Lungenklinik
City
Köln
ZIP/Postal Code
51109
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Schleswig-Holstein
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
ZIP/Postal Code
32429
Country
Germany
Individual Site Status
Recruiting
Facility Name
Queen Elizabeth Hospital
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Prince of Wales Hospital
City
New Territories
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Soroka University Medical Center, Itzchak Rager Blvd.
City
Beer Seva
ZIP/Postal Code
84101
Country
Israel
Individual Site Status
Recruiting
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Name
Oncology Institute, Galilee Medical Center, Route 89 Nahariya-Cabri
City
Nahariya
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center
City
Petah Tiqva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera San Giuseppe Moscati
City
Avellino
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Fondazoine del Piemonte per l'Oncologia
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Policlinico San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
AORN Cardarelli
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera dei Colli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Policlinico S. Matteo, Dipartimento Oncologia Ematologia-Oncologia Medica
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Sanitaria Territoriale Pesaro e Urbino (AST)
City
Pesaro
ZIP/Postal Code
61122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Guglielmo da Saliceto AUSL di Piacenza
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Regina Elena Institute for Cancer Research
City
Rome
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Bergamo Ovest- ospedale di Treviglio
City
Treviglio
ZIP/Postal Code
24047
Country
Italy
Individual Site Status
Recruiting
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Ziekenhuis Gelderse Vallei
City
Ede
ZIP/Postal Code
6716 RP
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Ziekenhuis St Jansdal
City
Harderwijk
ZIP/Postal Code
3844 DG
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
TweeSteden Ziekenhuis
City
Tilburg
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Hospital Prof. Doutor Fernando Fonseca
City
Amadora
ZIP/Postal Code
2720276
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Fundacao Champalimaud
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente
City
Lisboa
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitario Sao Joao, EPE
City
Porto
ZIP/Postal Code
4202-451
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA
City
Senhora da Hora
ZIP/Postal Code
4464-513
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Raffles Hospital
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Tang Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de la Santa Creu i de Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Dexeus (USP Institut Universitari Dexeus/Hospital Universitari Quiron Dexeus)
City
Barcelona
ZIP/Postal Code
8028
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall D'Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Parc Tauli
City
Barcelona
ZIP/Postal Code
8208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Doctor Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Jaen
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28020
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta de Hierro de Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Sant Joan de Reus
City
Reus
ZIP/Postal Code
43204
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario de Malaga
City
Rincon de la Victoria
ZIP/Postal Code
29011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio
City
Seville
ZIP/Postal Code
41014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Instituto Valenciano De Oncologia (IVO)
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Vithas Valencia 9 de Octubre
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Individual Site Status
Recruiting
Facility Name
Changhua Christian Hospital
City
Changhua City
ZIP/Postal Code
500-06
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
E-DA Hospital
City
Kaohsiung City
ZIP/Postal Code
824
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Memorial Hospital Kaohsiung
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chi Mei Hospital, Liouying
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical Foundation
City
Taoyuan City
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Istanbul University Cerrahpasa Medical Faculty Hospital
City
Fatih
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medipol Mega University Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Turgut Ozal Medical Faculty
City
Malatya
ZIP/Postal Code
44300
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-626-6216
Description
Gilead Clinical Trials Website

Learn more about this trial

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

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