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 progression-free survival (PFS) and 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 - September 2027

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 (221)

California Cancer Associates for Research and Excellence

San Marcos, California, United States, 92069

Innovative Clinical Research Institute

Whittier, California, United States, 90606

Eastern CT Hematology and Oncology Associates

Norwich, Connecticut, United States, 06360

Lake City Cancer Care

Lake City, Florida, United States, 32024

Florida Cancer Specialists

Sarasota, Florida, United States, 34232

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Peachtree Hematology Oncology Consultants

Atlanta, Georgia, United States, 30318

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

Texas Oncology

Dallas, Texas, United States, 75246

Texas Oncology- Denison

Sherman, Texas, United States, 75090

US Oncology Investigational Products Center (IPC)

Arlington, Virginia, United States, 22205

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

Centro Medico Barrio Parque

Ciudad Autanoma Buenos Aires, Argentina, 1426

Sanatorio Allende

Cordoba, 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

CAIPO - Centro para la Atención Integral del Paciente Oncológico

San Miguel de Tucumán, Argentina, 4000

Clínica Viedma

Viedma, Argentina, 8500

Klinikum Klagenfurt am Woerthersee

Klagenfurt Am Woerthersee, Austria

Ordensklinikum Linz GmbH, Elisabethinen

Linz, Austria, 4020

Klinikum Wels-Grieskirchen

Wels, Austria, 4600

Krankenhaus Nord - Klinik Floridsdorf

Wien, Austria, A-1140

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

Ijui, Brazil, 98700-000

Centro Des Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho

Jau, Brazil, 17210080

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

Sao Paulo, Brazil, 03102002

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

Quebec, Canada, J7Z 2V4

Centre de santé et services sociaux de Rimouski-Neigette

Rimouski, Canada, G5L5T1

Clinica Alemana de Santiago

Las Condes, Chile, 7550000

Orlandioncologia

Providencia, Chile, 7500006

Oncovida- Santiago

Providencia, Chile, 7510035

Clinica Puerto Montt

Puerto Montt, Chile, 5500243

Biocinetic

Santiago, Chile, 8331143

James Lind Centro de Investigacion del Cancer

Temuco, Chile, 4800827

Oncocentro APYS

Vina 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

Nanfang Hospital, Southern Medical University

Guangzhou, China, 510515

Zhejiang Cancer Hospital

Hangzhou, China, 310005

Anhui Chest Hospital

Hefei, China, 230022

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 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

CHU de Caen

Caen, France, 14000

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

Centre Antoine Lacassagne

Nice, France, 6189

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

Institut de Cancerologie Strasbourg Europe (ICANS)

Strasbourg, France, 67033

Hôpital Foch

Suresnes, France, 92150

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

Toulon cedex, France, 83056

Augusta-Kranken-Anstalt gGmbh Klinik für Hämatologie Onkologie und Palliativmedizin

Bochum, Germany, 44791

Klinikum Chemnitz gGmbH

Chemnitz, Germany, 9116

Universitatsklinikum Essen / Westdeutsches Tumorzentrum, Innere Klinik (Tumorforschung)

Essen, Germany, 45122

Universitätsklinikum Freiburg, Klinik für Innere Medizin I Hämatologie, Onkologie und Stammzelltransplantation

Freiburg, Germany, 79106

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

Klinikum Kassel

Kassel, Germany, 34125

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

Köln, Germany, 51109

Universitatsklinikum Schleswig-Holstein

Lubeck, Germany, 23538

Johannes Wesling Klinikum Minden

Minden, Germany, 32429

Munchen Klinik Bogenhausen, Klinik fur Pneumologie und Pneumologische Onkologie

Munchen, Germany, 81925

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

Prince of Wales Hospital

New Territories, Hong Kong

Soroka University Medical Center, Itzchak Rager Blvd.

Beer Seva, Israel, 84101

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

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

Nahariya, Israel

Rabin Medical Center

Petah Tiqva, Israel, 49100

Kaplan Medical Center

Rehovot, Israel, 76100

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Azienda Ospedaliera San Giuseppe Moscati

Avellino, Italy

IRCCS Fondazoine del Piemonte per l'Oncologia

Candiolo, Italy, 10060

Azienda Socio Sanitaria Territoriale di Cremona

Cremona, Italy, 26100

Ospedale Policlinico San Martino

Genova, Italy, 16132

Ospedale San Raffaele

Milano, Italy, 20132

Azienda Ospedaliero Universitaria di Modena

Modena, Italy, 41124

AORN Cardarelli

Naples, Italy, 80131

Azienda Ospedaliera dei Colli

Napoli, 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

ASST Bergamo Ovest- ospedale di Treviglio

Treviglio, Italy, 24047

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

Hyogo, Japan, 670-8520

Hyogo Cancer Center

Hyogo, 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

SMG - SNU Boramae Medical Center

Dongjak-Gu, Korea, Republic of, 07061

Samsung Medical Center

Gangnam-Gu, Korea, Republic of, 6351

National Cancer Center

Goyang, Korea, Republic of, 410769

Chungbuk National University Hospital

Heungdeok-Gu, Korea, Republic of, 361-711

Inha University Hospital

Incheon, Korea, Republic of, 22332

Gachon University Gil Medical Center

Inchon, Korea, Republic of, 21565

Kosin University Gospel Hospital

Seo-gu, Korea, Republic of, 49267

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 03722

Asan Medical Center

Seoul, Korea, Republic of, 05505

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

Seoul, Korea, Republic of, 06591

Ajou University Hospital

Suwon-si, Korea, Republic of, 16499

The Catholic University of Korea, Saint Vincent's Hospital

Suwon, Korea, Republic of, 16247

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

Mexico, Mexico, 3100

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Mitras Centro, Mexico, 64460

Oaxaca Site Management Organization

Oaxaca, Mexico, 68000

Centro de Investigacion Clinica de Oaxaca

Oaxaca, Mexico, 68020

Clinical Medical Research SC.

Orizaba Centro, Mexico, 94300

Clinica Integral Internacional de Oncologia S de RL de CV

Puebla, 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

Lisboa, Portugal, 1089

Fundacao Champalimaud

Lisboa, Portugal, 1400-038

Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente

Lisboa, Portugal

Hospital Beatriz Angelo. Hospital de Loures.

Lisbon, Portugal, 2674-514

Centro Hospitalar Universitario Sao Joao, EPE

Porto, Portugal, 4202-451

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

Senhora da Hora, Portugal, 4464-513

Raffles Hospital

Singapore, Singapore, 188770

Tang Tock Seng Hospital

Singapore, Singapore, 308433

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

Cordoba, Spain, 14004

Hospital Doctor Josep Trueta

Girona, Spain, 17007

Hospital Universitario de Jaen

Jaen, Spain, 23007

Hospital Universitario de Canarias

Las Palmas de G.C., 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

Rincon de la Victoria, Spain, 29011

Hospital Universitario Virgen Macarena

Sevilla, 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 City, Taiwan, 500-06

E-DA Hospital

Kaohsiung City, Taiwan, 824

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 807

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung, Taiwan, 83301

National Cheng Kung University Hospital

Tainan, Taiwan, 70403

Chi Mei Hospital, Liouying

Tainan, Taiwan

National Taiwan University Hospital

Taipei City, Taiwan, 100

Taipei Veterans General Hospital

Taipei, Taiwan, 10002

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

Taoyuan City, Taiwan, 33305

Ankara Bilkent Sehir Hastanesi

Ankara, Turkey, 06550

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, Turkey, 6200

Trakya University Faculty of Medicine

Edirne, Turkey, 22030

Istanbul University Cerrahpasa Medical Faculty Hospital

Fatih, Turkey, 34098

Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi

Istanbul, Turkey, 34093

Medipol Mega University Hospital

Istanbul, Turkey

Acibadem Mehmet Ali Aydinlar Universitesi Atakent Hastanesi

Kaakaekmece, Turkey, 34303

Turgut Ozal Medical Faculty

Malatya, Turkey, 44300

Colchester General Hospital

Colchester, United Kingdom, CO4 5JL

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

University Hospital Southampton Nhs Foundation Trust

Southampton, United Kingdom, SO16 6YD

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