Study Details

OVERVIEW

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 (STAR-121)

PROTOCOL 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 overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable genomic alteration.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

Non-small Cell Lung Cancer

Gender

N/A

Date

October 2022 - June 2028

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

Zimberelimab, Domvanalimab, Pembrolizumab, Carboplatin, Cisplatin, Paclitaxel, Nab-paclitaxel, Pemetrexed

Eligibility Information

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.

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.

Locations

Locations (186)

Innovative Clinical Research Institute

Whittier, California, United States, 90606

George Washington Medical Faculty Associates

Washington D.C., District of Columbia, United States, 20052

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Illinois Cancer Care

Peoria, Illinois, United States, 61615

Messino Cancer Centers

Asheville, North Carolina, United States, 28806

Oncology Hematology Care, Inc.

Cincinnati, Ohio, United States, 45242

Hematology & Oncology Associates

Eugene, Oregon, United States, 97401

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, United States, 15212

Texas Oncology - Austin

Austin, Texas, United States, 78745

Oncology and Hematology Associates of Southwest Virginia, Inc

Blacksburg, Virginia, United States, 24060

Northwest Cancer Specialists, PC

Vancouver, Washington, United States, 98684

Investigaciones CORI S.R.L.

Capital, Argentina, F5300COE

Centro Médico Privado Centro de Especialidades Médicas Ambulatorias e Investigación Clínica

Cardoba, Argentina, X5008HHW

Sanatorio Allende

Córdoba, Argentina, 5000

Sanatorio Britanico de Rosario

Rosario, Argentina, 2000

Sanatorio Parque de Rosario

Rosario, Argentina, S2000DSV

Hospital Provincial del Centenario

Rosario, Argentina, S2002KDS

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, Argentina, S2013DTC

Clínica Viedma

Viedma, Argentina, 8500

Ordensklinikum Linz GmbH, Elisabethinen

Linz, Austria, 4020

Krankenhaus Nord - Klinik Floridsdorf

Vienna, Austria, A-1140

Klinikum Wels-Grieskirchen

Wels, Austria, 4600

Algemeen Ziekenhuis Sint-Lucas

Aalst, Belgium, 9300

Grand Hopital de Charleroi asbl (GHdC)

Charleroi, Belgium, 6000

AZ Sint-Maarten

Mechelen, Belgium, 2800

CHU UCL Namur / Site Sainte Elisabeth

Namur, Belgium, 5000

Cenantron Centro Avançado de Tratamento Oncologico Ltda

Belo Horizonte, Brazil, 30130-090

Hospital Evangelico de Cachoeiro de Itapemirim

Cachoeiro de Itapemirim, Brazil, 29308-014

Fundacao Universidade De Caxias Do Sul - FUCS/RS

Caxias do Sul, Brazil, 95070-560

Instituto do Câncer do Ceará - ICC

Fortaleza, Brazil, 60430-230

Oncosite - Centro de Pesquisa Clinica em Oncologia LTDA

Ijuí, Brazil, 98700-000

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil, 90020-090

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil, 90035-903

Hospital São Lucas da PUCRS

Porto Alegre, Brazil, 90610-000

Hospital Ana Nery Santa Cruz do Sul

Santa Cruz do Sul, Brazil, 96810-110

Instituto Brasiliero de Controle do Cancer IBCC

São Paulo, Brazil, 03102002

Centro Des Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho

São Paulo, Brazil, 17210080

Centre Integre de sante et de services sociaux de la Monteregie Centre

Greenfield Park, Canada, J4V 2H1

Moncton Hospital

Moncton, Canada, E1C 6Z8

CISSS des Laurentides

Québec, Canada, J7Z 2V4

Centre de santé et services sociaux de Rimouski-Neigette

Rimouski, Canada, G5L5T1

Clinica Alemana de Santiago

Las Condes, Chile, 7550000

Clinica Puerto Montt

Port Montt, Chile, 5500243

Orlandioncologia

Providencia, Chile, 7500006

Oncovida- Santiago

Providencia, Chile, 7510035

Biocinetic

Santiago, Chile, 8331143

James Lind Centro de Investigacion del Cancer

Temuco, Chile, 4800827

Oncocentro APYS

Viña del Mar, Chile, 2520612

West China Hospital Sichuan University

Chengdu, China, 610041

Chongqing University Cancer Hospital

Chongqing, China, 400030

Deyang People's Hospital

Deyang, China, 618000

Fujian Cancer Hospital

Fuzhou, China, 350014

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China, 510120

Guangzhou First People's Hospital

Guangzhou, China, 510180

Zhejiang Cancer Hospital

Hangzhou, China, 310005

The Second Affiliated Hospital of Nanchang University

Jiangxi, China, 330006

Shandong Cancer Hospital

Jinan, China, 250021

Jiangxi Chest Hospital

Nanchang, China, 330006

Nanjing Drum Tower Hospital

Nanjing, China, 210008

Guangxi Medical University Cancer Hospital

Nanning, China, 530021

Shanghai Chest Hospital

Shanghai, China, 200030

Shanghai East Hospital

Shanghai, China, 200120

Shanghai Pulmonary Hospital

Shanghai, China, 200433

Cancer Hospital of Shantou University Medical College

Shantou, China, 0754-88555844

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China, 300181

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China, 430022

Tongji Hospital Tongji Medical College of Hust

Wuhan, China, 430030

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China, 710049

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, China, 453100

Henan Cancer Hospital

Zhengzhou, China, 450008

Ambroise-Pare Hospital, Assistance Publique - Hopitaux de Paris

Boulogne-Billancourt, France, 92100

Clinique Victor Hugo, Centre de Cancerologie de la Sarthe

Le Mans, France, 72000

Hopital Nord

Marseille, France, 13005

Institut de Cancer de Montpellier (ICM) - Val d'Aurelle

Montpellier, France, 34928

Institut de cancerologie de l'ouest (ICO)

Saint-Herblain, France, 44805

Hopital d'Instruction des Armees (HIA) Begin

Saint-Mandé, France, 94160

Centre Hospitalier de Saint-Quentin

Saint-Quentin, France, 2100

Hôpital Foch

Suresnes, France, 92150

CHI de Toulon la Seyne-sur-Mer Hopital Sainte Musse

Toulon, France, 83056

Kliniken der Stadt Köln ggmbh, Krankenhaus Koln-Merheim/Lungenklinik

Cologne, Germany, 51109

Universitatsklinikum Essen / Westdeutsches Tumorzentrum, Innere Klinik (Tumorforschung)

Essen, Germany, 45122

LungenClinic Grosshansdorf

Großhansdorf, Germany, 22927

Krankenhaus Martha-Maria Halle Dölau

Halle, Germany, 06120

Asklepios Kliniken Hamburg

Hamburg, Germany, 21075

Katholisches Marienkrankenhaus gGmbH

Hamburg, Germany, 22087

Lungenklinik Hemer, Zentrum fur Pneumologie and Thoraxchirurgie

Hemer, Germany, 58675

Vincentius-Diakonissen-Kliniken gAG, St. Vincentius-Kliniken, Medizinische Klinik 2

Karlsruhe, Germany, 76137

Universitatsklinikum Schleswig-Holstein

Lübeck, Germany, 23538

Johannes Wesling Klinikum Minden

Minden, Germany, 32429

Sana Klinikum Offenbach GmbH, Medizinische Klinik IV, Hämatologie und Internistische Onkologie

Offenbach, Germany, 63069

Queen Elizabeth Hospital

Hong Kong, Hong Kong, 999077

Queen Mary Hospital

Hong Kong, Hong Kong, 999077

Prince of Wales Hospital

New Territories, Hong Kong

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

Oncology Institute, Galilee Medical Center, Route 89 Nahariya-Cabri

Nahariya, Israel

Rabin Medical Center

Petah Tikva, Israel, 49100

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Azienda Ospedaliera San Giuseppe Moscati

Avellino, Italy

Azienda Socio Sanitaria Territoriale di Cremona

Cremona, Italy, 26100

Ospedale Policlinico San Martino

Genova, Italy, 16132

Ospedale San Raffaele

Milan, Italy, 20132

AORN Cardarelli

Naples, Italy, 80131

IRCCS Policlinico S. Matteo, Dipartimento Oncologia Ematologia-Oncologia Medica

Pavia, Italy, 27100

Azienda Sanitaria Territoriale Pesaro e Urbino (AST)

Pesaro, Italy, 61122

Ospedale Guglielmo da Saliceto AUSL di Piacenza

Piacenza, Italy, 29100

Centro di Riferimento Oncologico

Pordenone, Italy, 33081

Regina Elena Institute for Cancer Research

Rome, Italy, 00144

National Cancer Center Hospital East

Chiba, Japan, 277-0882

National Hospital Organization Shikoku Cancer Center

Ehime, Japan, 791-0280

Kyushu University Hospital

Fukuoka, Japan, 812-8582

Kurume University Hospital

Fukuoka, Japan, 830-0011

National Hospital Organization Himeji Medical Center

Hyōgo, Japan, 670-8520

Hyogo Cancer Center

Hyōgo, Japan, 673-8558

Kanazawa University Hospital

Ishikawa, Japan, 920-8641

Kanagawa Cancer Center

Kanagawa, Japan, 241-0815

Sendai Kousei Hospital

Miyagi, Japan, 981-0914

Niigata Cancer Center Hospital

Niigata, Japan, 951-8566

Osaka Metropolitan University Hospital

Osaka, Japan, 545-8586

Osaka Medical and Pharmaceutical University Hospital

Osaka, Japan, 569-8686

Kindai University Hospital

Osaka, Japan, 589-8511

National Hospital Organization Kinki Chuo Chest Medical Center

Osaka, Japan, 591-8555

Saitama Medical University

Saitama, Japan, 350-1298

Health Pharma Professional Research S.A. de C.V.

México, Mexico, 3100

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Mitras Centro, Mexico, 64460

Oaxaca Site Management Organization

Oaxaca City, Mexico, 68000

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, Mexico, 68020

Clinical Medical Research SC.

Orizaba Centro, Mexico, 94300

Clinica Integral Internacional de Oncologia S de RL de CV

Puebla City, Mexico, 72530

FAICIC Clínical Research

Veracruz, Mexico, 91900

Amphia Ziekenhuis

Breda, Netherlands, 4818 CK

Ziekenhuis Gelderse Vallei

Ede, Netherlands, 6716 RP

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 GZ

Ziekenhuis St Jansdal

Harderwijk, Netherlands, 3844 DG

TweeSteden Ziekenhuis

Tilburg, Netherlands

Hospital Prof. Doutor Fernando Fonseca

Amadora, Portugal, 2720276

Instituto Português de Oncologia de Lisboa Francisco Gentil

Lisbon, Portugal, 1089

Fundacao Champalimaud

Lisbon, Portugal, 1400-038

Hospital Beatriz Angelo. Hospital de Loures.

Lisbon, Portugal, 2674-514

Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente

Lisbon, Portugal

Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA

Senhora da Hora, Portugal, 4464-513

Tang Tock Seng Hospital

Singapore, Singapore, 308433

Samsung Medical Center

Gangnam-Gu, South Korea, 6351

National Cancer Center

Goyang, South Korea, 410769

Chungbuk National University Hospital

Heungdeok-Gu, South Korea, 361-711

Gachon University Gil Medical Center

Inchon, South Korea, 21565

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea, 06591

The Catholic University of Korea, Saint Vincent's Hospital

Suwon, South Korea, 16247

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain, 08041

Hospital Universitari Dexeus (USP Institut Universitari Dexeus/Hospital Universitari Quiron Dexeus)

Barcelona, Spain, 8028

Hospital Universitari Vall D'Hebron

Barcelona, Spain, 8035

Hospital Parc Tauli

Barcelona, Spain, 8208

Hospital Universitario Reina Sofia

Córdoba, Spain, 14004

Hospital Doctor Josep Trueta

Girona, Spain, 17007

Hospital Universitario de Jaen

Jaén, Spain, 23007

Hospital Universitario de Canarias

Las Palmas de Gran Canaria, Spain, 35016

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain, 28020

Clinica Universidad de Navarra

Madrid, Spain, 28027

Hospital Universitario La Paz

Madrid, Spain, 28046

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Spain, 28222

Hospital Sant Joan de Reus

Reus, Spain, 43204

Hospital Regional Universitario de Malaga

Rincón de la Victoria, Spain, 29011

Hospital Universitario Virgen Macarena

Seville, Spain, 41009

Hospital Universitario Virgen del Rocio

Seville, Spain, 41014

Instituto Valenciano De Oncologia (IVO)

Valencia, Spain, 46009

Hospital Universitari i Politecnic La Fe

Valencia, Spain, 46015

Hospital Vithas Valencia 9 de Octubre

Valencia, Spain, 46015

Changhua Christian Hospital

Changhua, Taiwan, 500-06

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 807

E-DA Hospital

Kaohsiung City, Taiwan, 824

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung City, Taiwan, 83301

Chi Mei Hospital, Liouying

Tainan, Taiwan, 736

Taipei Veterans General Hospital

Taipei, Taiwan, 10002

National Taiwan University Hospital

Taipei, Taiwan, 100

Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical Foundation

Taoyuan, Taiwan, 33305

Ankara Bilkent Sehir Hastanesi

Ankara, Turkey (Türkiye), 06550

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, Turkey (Türkiye), 6200

Trakya University Faculty of Medicine

Edirne, Turkey (Türkiye), 22030

Istanbul University Cerrahpasa Medical Faculty Hospital

Fatih, Turkey (Türkiye), 34098

Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi

Istanbul, Turkey (Türkiye), 34093

Medipol Mega University Hospital

Istanbul, Turkey (Türkiye)

Acibadem Mehmet Ali Aydinlar Universitesi Atakent Hastanesi

Kaakaekmece, Turkey (Türkiye), 34303

Turgut Ozal Medical Faculty

Malatya, Turkey (Türkiye), 44300

St Bartholomew's Hospital, Barts Health NHS Trust

London, United Kingdom, EC1A 7BE

The Christie NHS Foundation Trust, Department of Medical Oncology

Manchester, United Kingdom, M20 4BX

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