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COMPLETED
NCT03976323
PHASE3

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

View on ClinicalTrials.gov

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

BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Pemetrexed

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Cisplatin

IV infusion

DRUG

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

And 78 more locations on ClinicalTrials.gov