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Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)
Sponsor: Merck Sharp & Dohme LLC
Summary
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, versus (vs) pembrolizumab plus maintenance pemetrexed for the treatment of non-squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).
Official title: A Phase 3 Study of Pembrolizumab in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants With Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1003
Start Date
2019-06-28
Completion Date
2026-01-30
Last Updated
2026-09-28
Healthy Volunteers
No
Interventions
Pembrolizumab
IV infusion
Pemetrexed
IV infusion
Carboplatin
IV infusion
Cisplatin
IV infusion
Olaparib
Oral Tablet
Locations (178)
Alabama Oncology Bruno Cancer Center ( Site 0001)
Birmingham, Alabama, United States
Northwest Alabama Cancer Center, PC ( Site 0002)
Muscle Shoals, Alabama, United States
Disney Family Cancer Center ( Site 0005)
Burbank, California, United States
Boca Raton Regional Hospital ( Site 0018)
Boca Raton, Florida, United States
Mid-Florida Cancer Centers ( Site 0022)
Orange City, Florida, United States
Moffitt Cancer Center ( Site 0024)
Tampa, Florida, United States
Columbus Regional Research Institute ( Site 0098)
Columbus, Georgia, United States
Mount Sinai Hospital Medical Center ( Site 0032)
Chicago, Illinois, United States
Oncology of Northshore ( Site 0033)
Rolling Meadows, Illinois, United States
Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0036)
Merrillville, Indiana, United States
Medstar Good Samaritan Hospital ( Site 0040)
Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Institute ( Site 0041)
Detroit, Michigan, United States
Hattiesburg Clinic ( Site 0045)
Hattiesburg, Mississippi, United States
Frontier Oncology ( Site 0080)
Billings, Montana, United States
Bozeman Health Deaconness Cancer Center ( Site 0046)
Bozeman, Montana, United States
Waverly Hematology Oncology ( Site 0081)
Cary, North Carolina, United States
Thompson Cancer Survival Center ( Site 2812)
Knoxville, Tennessee, United States
University of Tennessee Medical Center Knoxville ( Site 0060)
Knoxville, Tennessee, United States
Renovatio Clinical ( Site 0062)
The Woodlands, Texas, United States
Cancer Care Northwest ( Site 0071)
Spokane Valley, Washington, United States
Hospital Italiano Regional del Sur ( Site 0509)
Bahía Blanca, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0511)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital Britanico de Buenos Aires ( Site 0500)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto Medico Rio Cuarto ( Site 0501)
Río Cuarto, Córdoba Province, Argentina
Centro Oncológico de Rosario ( Site 0507)
Rosario, Santa Fe Province, Argentina
Centro Medico San Roque ( Site 0506)
San Miguel de Tucumán, Tucumán Province, Argentina
Clínica Universitaria Reina Fabiola ( Site 0505)
Córdoba, Argentina
Sanatorio Privado San Geronimo S.R.L ( Site 0510)
Santa Fe, Argentina
Liverpool Hospital ( Site 1201)
Liverpool, New South Wales, Australia
Southern Medical Day Care Centre ( Site 1200)
Wollongong, New South Wales, Australia
Townsville General Hospital ( Site 1202)
Townsville, Queensland, Australia
Monash Cancer Centre ( Site 1205)
Clayton, Victoria, Australia
Social Medical Center - Otto Wagner Hospital ( Site 1301)
Vienna, State of Vienna, Austria
Innsbruck LKH ( Site 1302)
Innsbruck, Tyrol, Austria
Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)
Linz, Upper Austria, Austria
Klinikum Wels-Grieskirchen ( Site 1304)
Wels, Upper Austria, Austria
Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)
Vienna, Austria
Instituto do Cancer do Ceara ( Site 0201)
Fortaleza, Ceará, Brazil
Hospital Sao Rafael ( Site 0212)
Salvador, Estado de Bahia, Brazil
Oncologica do Brasil ( Site 0210)
Belém, Pará, Brazil
Hospital Tacchini ( Site 0208)
Bento Gonçalves, Rio Grande do Sul, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0209)
Porto Alegre, Rio Grande do Sul, Brazil
Saint Gallen Instituto de Oncologia ( Site 0206)
Santa Cruz do Sul, Rio Grande do Sul, Brazil
YNOVA Pesquisa Clinica ( Site 0215)
Florianópolis, Santa Catarina, Brazil
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0202)
Itajaí, Santa Catarina, Brazil
Centro de Hematologia e Oncologia ( Site 0205)
Joinville, Santa Catarina, Brazil
Hospital de Base de Sao Jose de Rio Preto ( Site 0204)
Sao Jose Rio Preto, São Paulo, Brazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0203)
Rio de Janeiro, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0200)
São Paulo, Brazil
BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0214)
São Paulo, Brazil
Hospital Paulistano - Amil Clinical Research ( Site 0207)
São Paulo, Brazil
Lions Gate Hospital ( Site 0106)
North Vancouver, British Columbia, Canada
BC Cancer - Victoria ( Site 0109)
Victoria, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre ( Site 0107)
Halifax, Nova Scotia, Canada
Health Sciences North Research Institute ( Site 0115)
Greater Sudbury, Ontario, Canada
Waterloo Regional Health Network (WRHN) ( Site 0117)
Kitchener, Ontario, Canada
Stronach Regional Cancer Centre ( Site 0101)
Newmarket, Ontario, Canada
CISSS de la Monteregie-Centre ( Site 0114)
Greenfield Park, Quebec, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0105)
Montreal, Quebec, Canada
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)
Montreal, Quebec, Canada
Centre de Sante et des Services Sociaux de Rimouski-Neigette ( Site 0104)
Rimouski, Quebec, Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103)
Sherbrooke, Quebec, Canada
Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0604)
Medellín, Antioquia, Colombia
Clinica de la Costa S.A.S. ( Site 0608)
Barranquilla, Atlántico, Colombia
Administradora Country S.A. ( Site 0603)
Bogotá, Bogota D.C., Colombia
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0601)
Bogotá, Bogota D.C., Colombia
Institut De Cancerologie De Lorraine ( Site 1409)
Vandœuvre-lès-Nancy, Ain, France
Centre Hospitalier De Chauny ( Site 1411)
Chauny, Aisne, France
CHU Caen ( Site 1406)
Caen, Calvados, France
CHU Angers ( Site 1405)
Angers, Maine-et-Loire, France
Hopital Robert Schuman ( Site 1402)
Vantoux, Moselle, France
Centre Jean Perrin ( Site 1407)
Clermont-Ferrand, Puy-de-Dome, France
Centre Hospitalier de Pau ( Site 1412)
Pau, Pyrenees-Atlantiques, France
CHU de Rouen ( Site 1403)
Rouen, Seine-Maritime, France
Hopital d'Instruction des Armees Begin ( Site 1413)
Saint-Mandé, Val-de-Marne, France
Studienzentrum Aschaffenburg ( Site 1525)
Aschaffenburg, Bavaria, Germany
Klinikum der LMU ( Site 1500)
Munich, Bavaria, Germany
Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1523)
Munich, Bavaria, Germany
Universitaetsklinikum Regensburg ( Site 1512)
Regensburg, Bavaria, Germany
Klinikum Wuerzburg Mitte gGmbH ( Site 1509)
Würzburg, Bavaria, Germany
Universitaetsklinikum Frankfurt ( Site 1513)
Frankfurt am Main, Hesse, Germany
Pneumologische Lehrklinik Universitaet Goettingen ( Site 1501)
Immenhausen, Hesse, Germany
Universitaetsmedizin Goettingen ( Site 1507)
Göttingen, Lower Saxony, Germany
Universitaetsklinikum Bonn ( Site 1524)
Bonn, North Rhine-Westphalia, Germany
Kliniken Essen Mitte ( Site 1517)
Essen, North Rhine-Westphalia, Germany
InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1514)
Koblenz, Rhineland-Palatinate, Germany
Helios Klinikum Erfurt GmbH ( Site 1502)
Erfurt, Thuringia, Germany
Katholisches Marienkrankenhaus gGmbH ( Site 1522)
Hamburg, Germany
National Hospital Organization Nagoya Medical Center ( Site 0806)
Nagoya, Aichi-ken, Japan
Aichi Cancer Center ( Site 0803)
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 0801)
Kashiwa, Chiba, Japan
Kanazawa University Hospital ( Site 0811)
Kanazawa, Ishikawa-ken, Japan
Kanagawa Cancer Center ( Site 0807)
Yokohama, Kanagawa, Japan
Sendai Kousei Hospital ( Site 0812)
Sendai, Miyagi, Japan
Kansai Medical University Hospital ( Site 0804)
Hirakata, Osaka, Japan
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)
Sakai, Osaka, Japan
Shizuoka Cancer Center ( Site 0802)
Suntogun, Shizuoka, Japan
National Hospital Organization Kyushu Medical Center ( Site 0805)
Fukuoka, Japan
Niigata Cancer Center Hospital ( Site 0808)
Niigata, Japan
Okayama University Hospital ( Site 0810)
Okayama, Japan