Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer
- Trial number:
- NCT05502237
- Trial phase:
- 3
- Study type:
- Immunotherapy, Targeted therapy
- Overall status:
- Recruiting
Study start date
October, 2022
Scientific 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
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.
Key
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
Study design
Primary purpose:
Treatment, Allocation:
Randomized, Intervention model:
Parallel Assignment, Masking:
None (Open Label),
Conditions
Non-small Cell Lung Cancer
Other study ID numbers
GS-US-626-6216; 2022-000578-25
Choose trial site (209)
Palo Verde Hematology Oncology Ltd
5601 W Eugie Ave # 106, Glendale, AZ 85304, USA
Innovative Clinical Research Institute
Whittier, CA 90606, USA
Eastern CT Hematology and Oncology Associates
Norwich, CT, USA
Peachtree Hematology Oncology Consultants
Colonial Homes, Atlanta, GA, USA
Illinois Cancer Care
8940 Wood Sage Rd, Peoria, IL 61615, USA
Oncovida- Santiago
Gral. Holley 2381, Providencia, Región Metropolitana, Chile
Clinica Puerto Montt
Calle Panamericana Nte. 400, Puerto Montt, Los Lagos, Chile
Biocinetic
Santiago, Santiago Metropolitan Region, Chile
Oncocentro APYS
Avenida - La Marina 1702, 2520598 Valparaíso, Viña del Mar, Valparaíso, Chile
Raffles Hospital
585 North Bridge Road Raffles Hospital, Singapore 188770
Tan Tock Seng Hospital Singapore
11 Jln Tan Tock Seng, Singapore 308433
Hospital Universitari Dexeus (USP Institut Universitari Dexeus/Hospital Universitari Quiron Dexeus)
Carrer de Sabino Arana, 5, 19, 08028 Barcelona, Spain
Hospital Universitario Reina Sofia
Av. Menendez Pidal, s/n, 14004 Córdoba, Spain
Hospital Doctor Josep Trueta
Avinguda de França, S/N, 17007 Girona, Spain
Hospital Universitario de Jaen
Campus Las Lagunillas s/n, 23071 Jaén, Spain
Hospital Universitario Fundacion Jimenez Diaz
Av. de los Reyes Católicos, 2, 28040 Madrid, Spain
Hospital Universitario Virgen Macarena
Av. Dr. Fedriani, 3, 41009 Sevilla, Spain
Taipei Veterans General Hospital
No. 201, Section 2, Shipai Rd, Beitou District, Taipei City, Taiwan 112
Florida Cancer Specialists
600 N Cattlemen Rd # 200, Sarasota, FL 34232, USA
Messino Cancer Centers
551 Brevard Rd, Asheville, NC 28806, USA
AHN Allegheny General Hospital
320 E North Ave, Pittsburgh, PA 15212, USA
Ordensklinikum Linz GmbH, Elisabethinen
Elisabethstraße 6, 4020 Linz, Austria
Algemeen Ziekenhuis Sint-Lucas
Groenebriel 1, 9000 Gent, Belgium
CHU UCL Namur / Site Sainte Elisabeth
Pl. Louise Godin 15, Route 352, 5000 Namur, Belgium
James Lind Centro de Investigacion del Cancer
Hochstetter 298, 4780000 Temuco, Araucanía, Chile
Shaare Zedek Medical Center
Shmu'el Bait St 12, Jerusalem, 9103102, Israel
Kaplan Medical Center
Derech Pasternak 1, Rehovot, Israel
Clinica Universidad de Navarra
C. del Marquesado de Sta. Marta, 1, 28027 Madrid, Spain
Hospital Universitario La Paz
P.º de la Castellana, 261, 28046 Madrid, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
C. Joaquín Rodrigo, 1, 28222 Majadahonda, Madrid, Spain
Hospital Regional Universitario de Malaga
Av. de Carlos Haya, 84, 29010 Málaga, Spain
Hospital Universitari i Politecnic La Fe
Avinguda de Fernando Abril Martorell, 106, 46026 València, Valencia, Spain
E-DA Hospital
No. 1號, Yida Rd, Yanchao District, Kaohsiung City, Taiwan 824
Kaohsiung Medical University Chung-Ho Memorial Hospital
No. 100號, Ziyou 1st Rd, Sanmin District, Kaohsiung City, Taiwan 80756
National Cheng Kung University Hospital
Tainan, East District, Tainan City, Taiwan
Chi Mei Hospital, Liouying
Liuying District, Tainan City, Taiwan 736
Lake City Cancer Care
3690 W US Hwy 90, Lake City, FL 32024, USA
Hematology & Oncology Associates
Eugene, OR 97401, USA
Arlington Cancer Center
906 W Randol Mill Rd, Arlington, TX 76012, USA
Texas Oncology
Dallas, TX 75246, USA
Centro Médico Privado Centro de Especialidades Médicas Ambulatorias e Investigación Clínica
Argentina
Sanatorio Allende
Obispo Oro 42, X5000BFB Córdoba, Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Italia 428, S2000DEJ Rosario, Santa Fe, Argentina
CAIPO - Centro para la Atención Integral del Paciente Oncológico
Av. Sarmiento 147, San Miguel de Tucumán, Tucumán, Argentina
Grand Hopital de Charleroi asbl (GHdC)
Grand'Rue 3, 6061 Charleroi, Belgium
AZ Sint-Maarten
Liersesteenweg 435, 2800 Mechelen, Belgium
Centre de santé et services sociaux de Rimouski-Neigette
Rimouski, QC G5L 5T1, Canada
Katholisches Marienkrankenhaus gGmbH
Alfredstraße 9, 22087 Hamburg, Germany
Vincentius-Diakonissen-Kliniken gAG, St. Vincentius-Kliniken, Medizinische Klinik 2
Südendstraße 32, 76137 Karlsruhe, Germany
Klinikum Kassel
Mönchebergstraße 41-43, 34125 Kassel, Germany
Queen Mary Hospital
Queen Mary Hospital Main Block, Pok Fu Lam Rd, Pok Fu Lam, Hong Kong
Prince of Wales Hospital
Lui Che Woo Clinical Sciences Building (Professorial Block), Ngan Shing St, Sha Tin, Hong Kong
Oncology Institute, Galilee Medical Center, Route 89 Nahariya-Cabri
89 Nahariya-Cabri, Nahariya, Israel
Tel-Aviv Sourasky Medical Center
Weizmann St 6, Tel Aviv-Yafo, Israel
Hospital Universitari Vall D'Hebron
Pg. de la Vall d'Hebron, 119, 08035 Barcelona, Spain
Hospital Parc Tauli
Parc Taulí, 1, 08208 Sabadell, Barcelona, Spain
Hospital Vithas Valencia 9 de Octubre
C/ de la Vall de la Ballestera, 59, 46015 València, Valencia, Spain
Changhua Christian Hospital
No. 176, Zhonghua Rd, Changhua City, Changhua County, Taiwan 500
Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical Foundation
Linkou District, New Taipei City, Taiwan 244
Eastern CT Hematology and Oncology Associates
Medical Office Building, 330 Washington St STE 220, Norwich, CT 06360, USA
Texas Oncology - Austin
Sunset Valley, TX 78745, USA
Texas Oncology- Denison
Sherman Denison, Sherman, TX 75090, USA
US Oncology Investigational Products Center (IPC)
Arlington, VA 22205, USA
Oncology and Hematology Associates of Southwest Virginia, Inc
2955 Market St NE, Christiansburg, VA 24073, USA
Northwest Cancer Specialists, PC
2501 NE 134th St #100, Vancouver, WA 98686, USA
Investigaciones CORI S.R.L.
Argentina
Sanatorio Britanico de Rosario
Paraguay 40, S2000 Rosario, Santa Fe, Argentina
Sanatorio Parque de Rosario
Rosario, Santa Fe Province, Argentina
Hospital Provincial del Centenario
Urquiza 3101, S2002KDT Santa Fe, Argentina
Clínica Viedma
Sarmiento 253, R8500 Viedma, Río Negro, Argentina
Klinikum Klagenfurt am Woerthersee
Feschnigstraße 11, 9020 Klagenfurt am Wörthersee, Austria
Krankenhaus Nord - Klinik Floridsdorf
Brünner Str. 68-70/Top 03, 1210 Wien, Austria
Orlandioncologia
Providencia, Santiago Metropolitan Region, Chile
Klinikum Chemnitz gGmbH
Flemmingstraße 2, 09116 Chemnitz, Germany
Krankenhaus Martha-Maria Halle Dölau
Röntgenstraße 1, 06120 Halle (Saale), Germany
Soroka University Medical Center, Itzchak Rager Blvd.
Be'er Sheva, Israel
Rabin Medical Center
Petah Tikva, Israel
Azienda Ospedaliera San Giuseppe Moscati
83100 Avellino, Province of Avellino, Italy
Azienda Ospedaliera dei Colli
Via Leonardo Bianchi, 80131 Napoli NA, Italy
ASST Bergamo Ovest- ospedale di Treviglio
Piazzale Ospedale Luigi Meneguzzo, 1, 24047 Treviglio BG, Italy
Amphia Ziekenhuis
4818 CK Breda, Netherlands
Ziekenhuis Gelderse Vallei
Willy Brandtlaan 10, 6716 RP Ede, Netherlands
Ziekenhuis St Jansdal
Wethouder Jansenlaan 90, 3844 DG Harderwijk, Netherlands
TweeSteden Ziekenhuis
Doctor Deelenlaan 5, 5042 AD Tilburg, Netherlands
Hospital Sant Joan de Reus
Avinguda del Doctor Josep Laporte, 2, 43204 Reus, Tarragona, Spain
Instituto Valenciano De Oncologia (IVO)
Carrer del Professor Beltrán Báguena, 8, 46009 València, Valencia, Spain
Texas Oncology
Santa Barbara, CA, USA
Oncology Hematology Care, Inc.
5053 Wooster Rd, Cincinnati, OH 45226, USA
Instituto do Câncer do Ceará - ICC
R. Papi Júnior, 1220 - Rodolfo Teófilo, Fortaleza - CE, 60430-230, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Rua Professor Annes Dias, 295 - Centro Histórico, Porto Alegre - RS, 90020-090, Brazil
Hospital São Lucas da PUCRS
Av. Ipiranga, 6690 - Partenon, Porto Alegre - RS, 90610-001, Brazil
Instituto Brasiliero de Controle do Cancer IBCC
Av. Alcântara Machado, 2576 - Mooca, São Paulo - SP, 03102-002, Brazil
CISSS des Laurentides
290 Rue de Montigny, Saint-Jérôme, QC J7Z 5T3, Canada
LungenClinic Grosshansdorf
Wöhrendamm 80, 22927 Großhansdorf, Germany
Asklepios Kliniken Hamburg
Eißendorfer Pferdeweg 52, 21075 Hamburg, Germany
Universitatsklinikum Schleswig-Holstein
Lübeck, Germany
Ospedale Policlinico San Martino
Largo Rosanna Benzi, 10, 16132 Genova GE, Italy
Ospedale San Raffaele
20132 Milan, Metropolitan City of Milan, Italy
Azienda Sanitaria Territoriale Pesaro e Urbino (AST)
Via Nanterre, 1, 61122 Pesaro PU, Italy
Ospedale Guglielmo da Saliceto AUSL di Piacenza
Via Taverna Giuseppe, 49, 29121 Piacenza PC, Italy
Regina Elena Institute for Cancer Research
Rome, Metropolitan City of Rome Capital, Italy
Hospital Prof. Doutor Fernando Fonseca
IC19 276, 2720-276 Amadora, Portugal
Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente
Alameda das Linhas de Torres, 117 1769-001 Lisboa, 1600 Lisboa, Portugal
Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA
Sra. da Hora, Portugal
Hospital de la Santa Creu i de Sant Pau
C/ de St. Antoni Maria Claret, 167, 08025 Barcelona, Spain
Hospital Universitario Virgen del Rocio
Av. Manuel Siurot, S/n, 41013 Sevilla, Spain
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung, Gushan District, Kaohsiung City, Taiwan
California Cancer Associates for Research and Excellence
San Marcos, CA 92069, USA
Moffitt Cancer Center
Tampa, FL 33612, USA
Centro Medico Barrio Parque
Palermo Chico, C1425 DF, Argentina
Klinikum Wels-Grieskirchen
Grieskirchner Str. 42, 4600 Wels, Austria
Cenantron Centro Avançado de Tratamento Oncologico Ltda
R. Padre Rolim, 120 - Santa Efigênia, Belo Horizonte - MG, 30130-090, Brazil
Hospital Evangelico de Cachoeiro de Itapemirim
R. Manoel Braga Machado, 2 - Nossa Sra. da Penha, Cachoeiro de Itapemirim - ES, 29308-020, Brazil
Fundacao Universidade De Caxias Do Sul - FUCS/RS
R. Francisco Getúlio Vargas, 1130 - Petrópolis, Caxias do Sul - RS, 95070-560, Brazil
Oncosite - Centro de Pesquisa Clinica em Oncologia LTDA
Ijuí, RS, 98700-000, Brazil
Centro Des Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho
R. Doná Silvéria, 150 - Chácara Braz Miraglia, Jaú - SP, 17210-070, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil
Hospital Ana Nery Santa Cruz do Sul
Centro, Santa Cruz do Sul - RS, 96810-110, Brazil
Centre Integre de sante et de services sociaux de la Monteregie Centre
3141 Bd Taschereau bureau 220, Greenfield Park, QC J4V 2H2, Canada
Moncton Hospital
135 Macbeath Ave, Moncton, NB E1C 6Z8, Canada
BC Cancer - Victoria
2410 Lee Ave, Victoria, BC V8R 6V5, Canada
Clinica Alemana de Santiago
Av Vitacura 5951, Vitacura, Región Metropolitana, Chile
Ambroise-Pare Hospital, Assistance Publique - Hopitaux de Paris
9 Av. Charles de Gaulle, 92100 Boulogne-Billancourt, France
CHU de Caen
Av. de la Côte de Nacre CS 30001, 14000 Caen, France
Clinique Victor Hugo, Centre de Cancerologie de la Sarthe
66 Rue de Degré, 72100 Le Mans, France
Hopital Nord
Chem. des Bourrely, 13015 Marseille, France
Institut de Cancer de Montpellier (ICM) - Val d'Aurelle
Euromedicine Park, 208 Av. des Apothicaires, 34090 Montpellier, France
Centre Antoine Lacassagne
33 Av. de Valombrose, 06100 Nice, France
Institut de cancerologie de l'ouest (ICO)
44800 Saint-Herblain, France
Hopital d'Instruction des Armees (HIA) Begin
69 Av. de Paris, 94160 Saint-Mandé, France
Centre Hospitalier de Saint-Quentin
1 Av. Michel de l'Hospital BP 608, 02321 Saint-Quentin, France
Institut de Cancerologie Strasbourg Europe (ICANS)
17 Rue Albert Calmette, 67200 Strasbourg, France
Hôpital Foch
40 Rue Worth, 92150 Suresnes, France
CHI de Toulon la Seyne-sur-Mer Hopital Sainte Musse
54 Rue Henri Sainte-Claire Deville, 83100 Toulon, France
Augusta-Kranken-Anstalt gGmbh Klinik für Hämatologie Onkologie und Palliativmedizin
44 Bochum, Germany
Universitatsklinikum Essen / Westdeutsches Tumorzentrum, Innere Klinik (Tumorforschung)
Hohlweg 12, 45147 Essen, Germany
Universitätsklinikum Freiburg, Klinik für Innere Medizin I Hämatologie, Onkologie und Stammzelltransplantation
79106 Freiburg im Breisgau-West, Germany
Lungenklinik Hemer, Zentrum fur Pneumologie and Thoraxchirurgie
58675 Hemer-Frönsberg, Germany
Kliniken der Stadt Köln ggmbh, Krankenhaus Koln-Merheim/Lungenklinik
Neufelder Str. 34, 51067 Köln, Germany
Johannes Wesling Klinikum Minden
Hans-Nolte-Straße 1, 32429 Minden, Germany
Munchen Klinik Bogenhausen, Klinik fur Pneumologie und Pneumologische Onkologie
81925 Munich-Bogenhausen, Germany
Queen Elizabeth Hospital
30 號 Gascoigne Rd, Yau Ma Tei, Hong Kong
IRCCS Fondazoine del Piemonte per l'Oncologia
SP142 km 3,95, 10060 Candiolo TO, Italy
Azienda Socio Sanitaria Territoriale di Cremona
Viale Concordia, 1, 26100 Cremona CR, Italy
AORN Cardarelli
Pad E primo piano maxillo, Via Antonio Cardarelli, 9, 80131 Napoli NA, Italy
IRCCS Policlinico S. Matteo, Dipartimento Oncologia Ematologia-Oncologia Medica
Viale Camillo Golgi, 19, 27100 Pavia PV, Italy
National Hospital Organization Shikoku Cancer Center
甲１６０ Minamiumemotomachi, Matsuyama, Ehime 791-0245, Japan
Kyushu University Hospital
3-chōme-1-1 Maidashi, Higashi Ward, Fukuoka, 812-8582, Japan
Hyogo Cancer Center
13-70 Kitaōjichō, 北王子町 Akashi, Hyogo 673-0021, Japan
Kanagawa Cancer Center
2-chōme-3-2 Nakao, Asahi Ward, Yokohama, Kanagawa 241-8515, Japan
Kindai University Hospital
377-2 Ōnohigashi, Osakasayama, Osaka 589-8511, Japan
Saitama Medical University
38 Morohongō, Moroyama, Iruma District, Saitama 350-0495, Japan
SMG - SNU Boramae Medical Center
Dongjak-gu, Seoul, South Korea
Samsung Medical Center
81 Irwon-ro, Gangnam-gu, Seoul, South Korea
National Cancer Center
323 Ilsan-ro, Goyang-si, Gyeonggi-do, South Korea
Chungbuk National University Hospital
Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, South Korea
Inha University Hospital
27 Inhang-ro, Jung-gu, Incheon, South Korea
Gachon University Gil Medical Center
21 Namdong-daero 774beon-gil, Guwol-dong, Namdong-gu, Incheon, South Korea
Kosin University Gospel Hospital
262 Gamcheon-ro, Seo-gu, Busan, South Korea
Asan Medical Center
88 Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
222 Banpo-daero, Seocho-gu, Seoul, South Korea
Ajou University Hospital
164 World cup-ro, Yeongtong-gu, Suwon, Gyeonggi-do, South Korea
The Catholic University of Korea, Saint Vincent's Hospital
296-12 Changgyeonggung-ro, Jongno-gu, Seoul, South Korea
Health Pharma Professional Research S.A. de C.V.
Av. Insurgentes Sur 662-Piso 3, Col. Del Valle, Benito Juárez, 03100 Ciudad de México, CDMX, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Av. Dr. José Eleuterio González S/N, Mitras Centro, 64460 Monterrey, N.L., Mexico
Oaxaca Site Management Organization
Centro, 68000 Oaxaca de Juárez, Oax., Mexico
Clinical Medical Research SC.
Centro, 94300 Orizaba, Ver., Mexico
Clinica Integral Internacional de Oncologia S de RL de CV
Calle 2-A Sur 3511, Carmen Huexotitla, 72534 Heroica Puebla de Zaragoza, Pue., Mexico
FAICIC Clínical Research
Av. 16 de Septiembre 1165, Ricardo Flores Magón, 91900 Veracruz, Ver., Mexico
Instituto Português de Oncologia de Lisboa Francisco Gentil
Lisbon, Portugal
Fundacao Champalimaud
Av. Brasília, 1400-038 Lisboa, Portugal
Hospital Beatriz Angelo. Hospital de Loures.
Loures, Portugal
Centro Hospitalar Universitario Sao Joao, EPE
Porto, Portugal
Hospital Clinic de Barcelona
C. de Villarroel, 170, L'Eixample, 08036 Barcelona, Spain
Hospital Universitario de Canarias
35016 Las Palmas de Gran Canaria, Las Palmas, Spain
National Taiwan University Hospital
No. 7號, Zhongshan S Rd, Zhongzheng District, Taipei City, Taiwan 100
Ankara Bilkent Sehir Hastanesi
Üniversiteler, 06800 Çankaya/Ankara, Türkiye
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Mehmet Akif Ersoy, 354/1. Sk., 06200 Yenimahalle/Ankara, Türkiye
Trakya University Faculty of Medicine
Unnamed Road, 22130 İskender/Edirne Merkez/Edirne, Türkiye
Istanbul University Cerrahpasa Medical Faculty Hospital
Cerrahpaşa, Koca Mustafapaşa Cd. No:53, 34098 Fatih/İstanbul, Türkiye
Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi
Eğitim, Göztepe Araştırma Hst., 34722 Kadıköy/İstanbul, Türkiye
Medipol Mega University Hospital
TEM Avrupa otoyolu göztepe çıkışı no:1, Göztepe, 34214 Bağcılar/İstanbul, Türkiye
Acibadem Mehmet Ali Aydinlar Universitesi Atakent Hastanesi
Halkalı Merkez, Turgut Özal Bulvari No:16, 34303 Küçükçekmece/İstanbul, Türkiye
Turgut Ozal Medical Faculty
44300 Battalgazi/Malatya, Türkiye
St Bartholomew's Hospital, Barts Health NHS Trust
W Smithfield, London EC1A 7BE, UK
CISSS des Laurentides
290 Rue de Montigny, Saint-Jérôme, QC J7Z 5T3, Canada
National Cancer Center Hospital East
Japan, 〒277-8577 Chiba, Kashiwa, Kashiwanoha, 6-chōme−５−１
National Hospital Organization Kinki Chuo Chest Medical Center
1180 Nagasonechō, Kita Ward, Sakai, Osaka 591-8025, Japan