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)

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)

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).

Study Overview

• Status: Completed
• Conditions: Carcinoma, Nonsquamous Non-small-cell Lung
• Intervention / Treatment: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Cisplatin; Drug: Olaparib

Detailed Description

This study has 2 phases: an Induction Phase of up to ~4 Cycles (up to ~12 weeks [cycle =3 weeks]) and a Maintenance Phase of up to ~31 cycles of pembrolizumab (cycle = 3 weeks]); total pembrolizumab treatment duration will be up to ~35 cycles (up to ~2 years). In the Induction Phase, participants receive pembrolizumab plus pemetrexed plus platinum (carboplatin or cisplatin, at the investigator's discretion). In the Maintenance Phase, participants with a partial or complete disease response or with stable disease after completing four cycles of induction therapy and who meet eligibility criteria will be randomly assigned to receive pembrolizumab plus maintenance olaparib OR pembrolizumab plus maintenance pemetrexed. In the Maintenance Phase, participants receive pembrolizumab for up to 31 cycles (cycle = 3 weeks) plus maintenance olaparib OR maintenance pemetrexed until progressive disease (PD), intolerable toxicities, or physician decision.

Qualified participants in each study arm of the maintenance phase (Pembrolizumab plus Olaparib and Pembrolizumab plus Pemetrexed) who complete up to ~35 cycles of pembrolizumab (up to ~2 years [cycle =3 weeks]) may be eligible to receive a second course of pembrolizumab for up to ~17 cycles (up to ~1 additional year). Per protocol, response or progression during the second pembrolizumab course will not be counted towards patient reported outcomes (PROs) or efficacy outcome measures and adverse events during the second pembrolizumab course will not be counted towards safety outcome measures.

• Study Type: Interventional
• Enrollment (Actual): 1003
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina, X5004SHP
    • Clínica Universitaria Reina Fabiola ( Site 0505)
  • Santa Fe, Argentina, S3000AOL
    • Sanatorio Privado San Geronimo S.R.L ( Site 0510)
  • Buenos Aires
    • Bahía Blanca, Buenos Aires, Argentina, B8001HXM
      • Hospital Italiano Regional del Sur ( Site 0509)
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
      • Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0511)
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
      • Hospital Britanico de Buenos Aires ( Site 0500)
  • Córdoba Province
    • Río Cuarto, Córdoba Province, Argentina, X5800AEV
      • Instituto Medico Rio Cuarto ( Site 0501)
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000KZE
      • Centro Oncológico de Rosario ( Site 0507)
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, T4000IAK
      • Centro Medico San Roque ( Site 0506)
• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital ( Site 1201)
    • Wollongong, New South Wales, Australia, 2500
      • Southern Medical Day Care Centre ( Site 1200)
  • Queensland
    • Townsville, Queensland, Australia, 4814
      • Townsville General Hospital ( Site 1202)
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Cancer Centre ( Site 1205)
• Austria
  • Vienna, Austria, 1210
    • Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Innsbruck LKH ( Site 1302)
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)
    • Wels, Upper Austria, Austria, 4600
      • Klinikum Wels-Grieskirchen ( Site 1304)
  • Vienna
    • Vienna, Vienna, Austria, 1145
      • Social Medical Center - Otto Wagner Hospital ( Site 1301)
• Brazil
  • Rio de Janeiro, Brazil, 20231-050
    • Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0203)
  • São Paulo, Brazil, 01246-000
    • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0200)
  • São Paulo, Brazil, 01321-001
    • BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0214)
  • São Paulo, Brazil, 01321-001
    • Hospital Paulistano - Amil Clinical Research ( Site 0207)
  • Ceará
    • Fortaleza, Ceará, Brazil, 60351-030
      • Instituto do Cancer do Ceara ( Site 0201)
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41253-190
      • Hospital Sao Rafael ( Site 0212)
  • Pará
    • Belém, Pará, Brazil, 66053-000
      • Oncologica do Brasil ( Site 0210)
  • Rio Grande do Sul
    • Bento Gonçalves, Rio Grande do Sul, Brazil, 95700-000
      • Hospital Tacchini ( Site 0208)
    • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
      • Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0209)
    • Santa Cruz do Sul, Rio Grande do Sul, Brazil, 96810-110
      • Saint Gallen Instituto de Oncologia ( Site 0206)
  • Santa Catarina
    • Florianópolis, Santa Catarina, Brazil, 88020-210
      • YNOVA Pesquisa Clinica ( Site 0215)
    • Itajaí, Santa Catarina, Brazil, 88301-220
      • Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0202)
    • Joinville, Santa Catarina, Brazil, 89201-260
      • Centro de Hematologia e Oncologia ( Site 0205)
  • São Paulo
    • Sao Jose Rio Preto, São Paulo, Brazil, 15080-000
      • Hospital de Base de Sao Jose de Rio Preto ( Site 0204)
• Canada
  • British Columbia
    • North Vancouver, British Columbia, Canada, V7L 2L7
      • Lions Gate Hospital ( Site 0106)
    • Victoria, British Columbia, Canada, V8R 6V5
      • BC Cancer - Victoria ( Site 0109)
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Queen Elizabeth II Health Sciences Centre ( Site 0107)
  • Ontario
    • Greater Sudbury, Ontario, Canada, P3E 5J1
      • Health Sciences North Research Institute ( Site 0115)
    • Kitchener, Ontario, Canada, N2G 1G3
      • Waterloo Regional Health Network (WRHN) ( Site 0117)
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Stronach Regional Cancer Centre ( Site 0101)
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • CISSS de la Monteregie-Centre ( Site 0114)
    • Montreal, Quebec, Canada, H3T 1M5
      • CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)
    • Montreal, Quebec, Canada, H2X 3E4
      • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0105)
    • Rimouski, Quebec, Canada, G5L 5T1
      • Centre de Sante et des Services Sociaux de Rimouski-Neigette ( Site 0104)
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103)
• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 050030
      • Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0604)
  • Atlántico
    • Barranquilla, Atlántico, Colombia, 080020
      • Clinica de la Costa S.A.S. ( Site 0608)
  • Bogota D.C.
    • Bogotá, Bogota D.C., Colombia, 110221
      • Administradora Country S.A. ( Site 0603)
    • Bogotá, Bogota D.C., Colombia, 111321
      • Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0601)
• France
  • Ain
    • Vandœuvre-lès-Nancy, Ain, France, 54519
      • Institut De Cancerologie De Lorraine ( Site 1409)
  • Aisne
    • Chauny, Aisne, France, 02300
      • Centre Hospitalier De Chauny ( Site 1411)
  • Calvados
    • Caen, Calvados, France, 14033
      • CHU Caen ( Site 1406)
  • Maine-et-Loire
    • Angers, Maine-et-Loire, France, 49100
      • CHU Angers ( Site 1405)
  • Moselle
    • Vantoux, Moselle, France, 57070
      • Hopital Robert Schuman ( Site 1402)
  • Puy-de-Dome
    • Clermont-Ferrand, Puy-de-Dome, France, 63011
      • Centre Jean Perrin ( Site 1407)
  • Pyrenees-Atlantiques
    • Pau, Pyrenees-Atlantiques, France, 64000
      • Centre Hospitalier de Pau ( Site 1412)
  • Seine-Maritime
    • Rouen, Seine-Maritime, France, 76000
      • CHU de Rouen ( Site 1403)
  • Val-de-Marne
    • Saint-Mandé, Val-de-Marne, France, 94163
      • Hopital d'Instruction des Armees Begin ( Site 1413)
• Germany
  • Hamburg, Germany, 22087
    • Katholisches Marienkrankenhaus gGmbH ( Site 1522)
  • Bavaria
    • Aschaffenburg, Bavaria, Germany, 63739
      • Studienzentrum Aschaffenburg ( Site 1525)
    • Munich, Bavaria, Germany, 80336
      • Klinikum der LMU ( Site 1500)
    • Munich, Bavaria, Germany, 81925
      • Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1523)
    • Regensburg, Bavaria, Germany, 93053
      • Universitaetsklinikum Regensburg ( Site 1512)
    • Würzburg, Bavaria, Germany, 97074
      • Klinikum Wuerzburg Mitte gGmbH ( Site 1509)
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60590
      • Universitaetsklinikum Frankfurt ( Site 1513)
    • Immenhausen, Hesse, Germany, 34376
      • Pneumologische Lehrklinik Universitaet Goettingen ( Site 1501)
  • Lower Saxony
    • Göttingen, Lower Saxony, Germany, 37075
      • Universitaetsmedizin Goettingen ( Site 1507)
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53127
      • Universitaetsklinikum Bonn ( Site 1524)
    • Essen, North Rhine-Westphalia, Germany, 45136
      • Kliniken Essen Mitte ( Site 1517)
  • Rhineland-Palatinate
    • Koblenz, Rhineland-Palatinate, Germany, 56068
      • InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1514)
  • Thuringia
    • Erfurt, Thuringia, Germany, 99089
      • Helios Klinikum Erfurt GmbH ( Site 1502)
• Japan
  • Fukuoka, Japan, 8108563
    • National Hospital Organization Kyushu Medical Center ( Site 0805)
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital ( Site 0808)
  • Okayama, Japan, 700-8558
    • Okayama University Hospital ( Site 0810)
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute ( Site 0809)
  • Tokyo, Japan, 135-8550
    • Cancer Institute Hospital of JFCR ( Site 0800)
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 460-0001
      • National Hospital Organization Nagoya Medical Center ( Site 0806)
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Aichi Cancer Center ( Site 0803)
  • Chiba
    • Kashiwa, Chiba, Japan, 2778577
      • National Cancer Center Hospital East ( Site 0801)
  • Ishikawa-ken
    • Kanazawa, Ishikawa-ken, Japan, 920-8641
      • Kanazawa University Hospital ( Site 0811)
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 241-8515
      • Kanagawa Cancer Center ( Site 0807)
  • Miyagi
    • Sendai, Miyagi, Japan, 981-0914
      • Sendai Kousei Hospital ( Site 0812)
  • Osaka
    • Hirakata, Osaka, Japan, 573-1191
      • Kansai Medical University Hospital ( Site 0804)
    • Sakai, Osaka, Japan, 591-8555
      • National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)
  • Shizuoka
    • Suntogun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center ( Site 0802)
• New Zealand
  • Wellington, New Zealand, 6021
    • Capital & Coast District Health Board - Wellington Hospital ( Site 1101)
  • Manawatu-Wanganui
    • Palmerston North, Manawatu-Wanganui, New Zealand, 4414
      • MidCentral DHB Palmerston North Hospital ( Site 1102)
• Poland
  • Greater Poland Voivodeship
    • Konin, Greater Poland Voivodeship, Poland, 62-500
      • Przychodnia Lekarska Komed ( Site 2416)
    • Poznan, Greater Poland Voivodeship, Poland, 61-693
      • MED-POLONIA Sp. z o.o. ( Site 2419)
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 31-202
      • Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)
  • Lower Silesian Voivodeship
    • Zgorzelec, Lower Silesian Voivodeship, Poland, 59-900
      • Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-781
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2418)
  • Silesian Voivodeship
    • Racibórz, Silesian Voivodeship, Poland, 47-400
      • Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)
  • Warmian-Masurian Voivodeship
    • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-357
      • Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie ( Site 2417)
• Romania
  • Brasov, Romania, 500152
    • Spitalul PDR Medlife ( Site 2509)
  • București
    • Bucharest, București, Romania, 013823
      • MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 2502)
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 407280
      • S.C. Radiotherapy Center Cluj S.R.L ( Site 2507)
    • Cluj-Napoca, Cluj, Romania, 400015
      • Cardiomed SRL Cluj-Napoca ( Site 2504)
  • Constanța County
    • Ovidiu, Constanța County, Romania, 905900
      • Ovidius Clinical Hospital OCH ( Site 2501)
  • Dolj
    • Craiova, Dolj, Romania, 200542
      • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2508)
  • Timiș County
    • Timișoara, Timiș County, Romania, 300239
      • Policlinica Oncomed SRL ( Site 2505)
• Russia
  • Moscow
    • Moscow, Moscow, Russia, 115478
      • Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 2000)
    • Moscow, Moscow, Russia, 119991
      • First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024)
    • Moscow, Moscow, Russia, 125284
      • Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009)
    • Moscow, Moscow, Russia, 125367
      • FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006)
  • Moscow Oblast
    • Balashikha, Moscow Oblast, Russia, 143900
      • Moscow Regional Oncological Dispensary ( Site 2028)
  • Nizhny Novgorod Oblast
    • Nizhny Novgorod, Nizhny Novgorod Oblast, Russia, 603081
      • Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)
  • Omsk Oblast
    • Omsk, Omsk Oblast, Russia, 644013
      • Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site 2010)
  • Samara Oblast
    • Samara, Samara Oblast, Russia, 443031
      • SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 194291
      • SBHI Leningrad Regional Clinical Hospital ( Site 2002)
    • Saint Petersburg, Sankt-Peterburg, Russia, 195271
      • SPb Central Clinical Railway Hospital ( Site 2003)
    • Saint Petersburg, Sankt-Peterburg, Russia, 197758
      • National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 2004)
    • Saint Petersburg, Sankt-Peterburg, Russia, 198255
      • SPb SBHI City Clinical Oncological Dispensary ( Site 2001)
  • Tatarstan, Respublika
    • Kazan', Tatarstan, Respublika, Russia, 420029
      • Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 2021)
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital ( Site 1000)
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital ( Site 1008)
  • Kyonggi-do
    • Goyang-si, Kyonggi-do, South Korea, 10408
      • National Cancer Center ( Site 1006)
    • Suwon, Kyonggi-do, South Korea, 16247
      • The Catholic University of Korea St. Vincent s Hospital ( Site 1003)
    • Suwon, Kyonggi-do, South Korea, 16499
      • Ajou University Hospital ( Site 1004)
  • Kyongsangnam-do
    • Jinju, Kyongsangnam-do, South Korea, 52727
      • Gyeongsang National University Hospital ( Site 1005)
  • North Chungcheong
    • Cheongju-si, North Chungcheong, South Korea, 28644
      • Chungbuk National University Hospital ( Site 1002)
  • Seoul
    • Songpa-gu, Seoul, South Korea, 05505
      • Asan Medical Center ( Site 1007)
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar ( Site 1702)
  • Seville, Spain, 41014
    • Hospital Universitario Nuestra Senora de Valme ( Site 1703)
  • Zaragoza, Spain, 50009
    • Hospital Clinico Lozano Blesa ( Site 1700)
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Hospital Universitario Quiron Madrid ( Site 1701)
  • Valenciana, Comunitat
    • Valencia, Valenciana, Comunitat, Spain, 46010
      • Hospital Clinico Universitario de Valencia ( Site 1706)
• Taiwan
  • Kaohsiung City, Taiwan, 833
    • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)
  • Taichung, Taiwan, 40447
    • China Medical University Hospital ( Site 0904)
  • Tainan, Taiwan, 70457
    • National Cheng Kung University Hospital ( Site 0905)
  • Taipei, Taiwan, 104
    • Mackay Memorial Hospital ( Site 0902)
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital ( Site 0900)
  • Taoyuan District, Taiwan, 333
    • Chang Gung Medical Foundation.Linkou Branch ( Site 0903)
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01120
    • Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 2101)
  • Ankara, Turkey (Türkiye), 06500
    • Gazi Universitesi Tip Fakultesi ( Site 2104)
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent Şehir Hastanesi ( Site 2105)
  • Istanbul, Turkey (Türkiye), 34093
    • Bezmialem Vakif Univ. Tıp Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107)
  • Istanbul, Turkey (Türkiye), 34722
    • Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2103)
  • Izmir, Turkey (Türkiye), 35040
    • Ege Universitesi Tip Fakultesi ( Site 2109)
  • Kayseri, Turkey (Türkiye), 38039
    • Erciyes Universitesi Tip Fakultesi ( Site 2108)
  • Samsun, Turkey (Türkiye), 55139
    • Ondokuz Mayıs Universitesi-Oncology department ( Site 2106)
  • Tekirdas
    • Tekirdağ, Tekirdas, Turkey (Türkiye), 59100
      • Namik Kemal Universitesi Tip Fakultesi ( Site 2100)
• Ukraine
  • Kyiv, Ukraine, 03115
    • Kyiv City Clinical Oncology Centre ( Site 2210)
  • Cherkasy Oblast
    • Cherkasy, Cherkasy Oblast, Ukraine, 18009
      • Cherkasy Regional Oncology Dispensary ( Site 2211)
  • Dnipropetrovsk Oblast
    • Dnipro, Dnipropetrovsk Oblast, Ukraine, 49102
      • Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 2201)
  • Ivano-Frankivsk Oblast
    • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
      • MI Precarpathian Clinical Oncology Center ( Site 2204)
  • Kharkivs’ka Oblast’
    • Kharkiv, Kharkivs’ka Oblast’, Ukraine, 61024
      • Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2212)
    • Kharkiv, Kharkivs’ka Oblast’, Ukraine, 61070
      • CNPE "Regional Center of Oncology"-Thoracic organs ( Site 2205)
  • Kirovohrad Oblast
    • Kropyvnitskiy, Kirovohrad Oblast, Ukraine, 25006
      • PP PPC Acinus Medical and Diagnostic Centre ( Site 2209)
  • Kyivska Oblast
    • Khodosovka, Kyivska Oblast, Ukraine, 08173
      • Medical Center Asklepion LLC ( Site 2234)
    • Kyiv, Kyivska Oblast, Ukraine, 03126
      • Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2213)
    • Kyiv, Kyivska Oblast, Ukraine, 03039
      • Medical Center Verum ( Site 2230)
  • Odesa Oblast
    • Odesa, Odesa Oblast, Ukraine, 65055
      • MI Odessa Regional Oncological Centre ( Site 2208)
  • Zakarpattia Oblast
    • Uzhhorod, Zakarpattia Oblast, Ukraine, 88000
      • Central City Clinical Hospital ( Site 2207)
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Birmingham Heartlands Hospital ( Site 1910)
  • London, City of
    • London, London, City of, United Kingdom, EC1M 6BQ
      • Barts Health NHS Trust - St Bartholomew s Hospital ( Site 1923)
    • London, London, City of, United Kingdom, SW10 9NH
      • Chelsea and Westminster Hospital ( Site 1901)
  • Suffolk
    • Bury St Edmunds, Suffolk, United Kingdom, IP33 2QZ
      • West Suffolk Hospitals NHS Trust ( Site 1919)
  • United Kingdom
    • Edinburgh, United Kingdom, United Kingdom, EH4 2XU
      • Western General Hospital, Edinburgh ( Site 1924)
  • Wales
    • Swansea, Wales, United Kingdom, SA2 8QA
      • Singleton Hospital ( Site 1909)
  • Worcestershire
    • Colchester, Worcestershire, United Kingdom, CO4 5JL
      • Colchester General Hospital ( Site 1911)
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Alabama Oncology Bruno Cancer Center ( Site 0001)
    • Muscle Shoals, Alabama, United States, 35661
      • Northwest Alabama Cancer Center, PC ( Site 0002)
  • California
    • Burbank, California, United States, 91505
      • Disney Family Cancer Center ( Site 0005)
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Regional Hospital ( Site 0018)
    • Orange City, Florida, United States, 32763
      • Mid-Florida Cancer Centers ( Site 0022)
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center ( Site 0024)
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Research Institute ( Site 0098)
  • Illinois
    • Chicago, Illinois, United States, 60608
      • Mount Sinai Hospital Medical Center ( Site 0032)
    • Rolling Meadows, Illinois, United States, 60008
      • Oncology of Northshore ( Site 0033)
  • Indiana
    • Merrillville, Indiana, United States, 46410
      • Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0036)
  • Maryland
    • Baltimore, Maryland, United States, 21239
      • Medstar Good Samaritan Hospital ( Site 0040)
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Institute ( Site 0041)
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic ( Site 0045)
  • Montana
    • Billings, Montana, United States, 59102
      • Frontier Oncology ( Site 0080)
    • Bozeman, Montana, United States, 59715
      • Bozeman Health Deaconness Cancer Center ( Site 0046)
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Waverly Hematology Oncology ( Site 0081)
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center Knoxville ( Site 0060)
    • Knoxville, Tennessee, United States, 37916
      • Thompson Cancer Survival Center ( Site 2812)
  • Texas
    • The Woodlands, Texas, United States, 77380
      • Renovatio Clinical ( Site 0062)
  • Washington
    • Spokane Valley, Washington, United States, 99216
      • Cancer Care Northwest ( Site 0071)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.
2. Have stage IV nonsquamous NSCLC.
3. Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is not indicated.
4. Have measurable disease based on RECIST 1.1.

5. Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.

   Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can start the induction phase. Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.

6. Have a life expectancy of at least 3 months.
7. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention.
8. Have not received prior systemic treatment for their advanced/metastatic NSCLC.
9. Have adequate organ function.
10. Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.
11. Male participants must refrain from donating sperm, and female participants must refrain from donating eggs to others or freeze/store for her own use during the treatment period and for 180 days afterwards.

Exclusion Criteria:

1. Has predominantly squamous cell histology NSCLC.
2. Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
3. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
4. Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
5. Has a known hypersensitivity to any components or excipients of cisplatin, carboplatin, pemetrexed, or olaparib.
6. Has an active autoimmune disease that has required systemic treatment in past 2 years.
7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
8. Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.
9. Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.
10. Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
11. Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
12. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
13. Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
14. Has completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pembrolizumab + Pemetrexed + Platinum Therapy + Olaparib; For the Induction Phase, participants receive 4 cycles (up to ~12 weeks [cycle = 3 weeks]): pembrolizumab 200 mg intravenous (IV) on Day 1 of each cycle (cycles 1 through 4) PLUS pemetrexed 500 mg/m^2 IV on Day 1 of each cycle (cycles 1 through 4) PLUS platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of each cycle (Cycles 1 through 4) OR cisplatin 75 mg/m^2 IV on Day 1 of each cycle (Cycles 1 through 4). If the participant has a complete/partial response or stable disease to induction therapy, the participant can enter the Maintenance Phase and receive pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. The participant can continue to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants can receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]).	Biological: Pembrolizumab; IV infusion; Other Names: MK-3475; KEYTRUDA®; Drug: Carboplatin; IV infusion; Other Names: PARAPLATIN®; Drug: Pemetrexed; IV infusion; Other Names: ALIMTA®; Drug: Cisplatin; IV infusion; Other Names: PLATINOL®; PLATINOL®-AQ; Drug: Olaparib; Oral Tablet; Other Names: LYNPARZA®
Active Comparator: Pembrolizumab + Pemetrexed + Platinum Therapy + Pemetrexed; For the Induction Phase, participants receive 4 cycles (up to ~12 weeks [cycle = 3 weeks]): pembrolizumab 200 mg IV on Day 1 of each cycle (cycles 1 through 4) PLUS pemetrexed 500 mg/m^2 IV on Day 1 of each cycle (cycles 1 through 4) PLUS platinum chemotherapy, investigator's choice: carboplatin AUC 5 mg/mL/min IV on Day 1 of each cycle (Cycles 1 through 4) OR cisplatin 75 mg/m^2 IV on Day 1 of each cycle (Cycles 1 through 4). If the participant has a complete/partial response or stable disease to induction therapy, the participant can enter the Maintenance Phase and receive pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m^2 IV on Day 1 of each 3-week cycle. The participant can continue to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants can receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]).	Biological: Pembrolizumab; IV infusion; Other Names: MK-3475; KEYTRUDA®; Drug: Carboplatin; IV infusion; Other Names: PARAPLATIN®; Drug: Pemetrexed; IV infusion; Other Names: ALIMTA®; Drug: Cisplatin; IV infusion; Other Names: PLATINOL®; PLATINOL®-AQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	PFS was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS was analyzed by the non-parametric Kaplan-Meier (K-M) method. The protocol specified final analysis of PFS is presented here for the first pembrolizumab course in the Maintenance Phase. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.	Up to ~31 months
Overall Survival (OS)	OS was defined as the time from randomization to death due to any cause. OS was analyzed by the non-parametric K-M method. Participants without documented death at the time of analyses were censored at the date of last known to be alive. The protocol specified final analysis of OS is presented here for the first pembrolizumab course in the Maintenance Phase. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.	Up to ~51 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experience One or More Adverse Events (AEs)	An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs will be reported. The protocol specified final analysis will be presented for the first pembrolizumab course.	Up to ~5 years
Number of Participants Who Discontinue Study Treatment Due to an AE	An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported. The protocol specified final analysis will be presented for the first pembrolizumab course.	Up to ~5 years
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score	EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in GHS and QoL combined score is presented. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.	Baseline and Week 24
Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score	EORTC QLQ-C30 is a questionnaire to assess QoL of cancer patients. Participant responses to questions on GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging raw scores of the 2 items and applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in GHS-QoL combined score. TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome was not done in the Induction Phase.	Up to ~24 months
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score	EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding cough (Item 1): "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score is presented. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.	Baseline and Week 24
TTD in EORTC QLQ-LC13 Cough (Item 1) Scale Score	EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding cough (Item 1): "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in cough (Item 1). TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.	Up to ~24 months
Change From Baseline in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score	EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding chest pain (Item 10): "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score is presented. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.	Baseline and Week 24
TTD in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score	EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding chest pain (Item 10): "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in chest pain (Item 10). TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final analysis for the first pembrolizumab course in Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.	Up to ~24 months
Change From Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question regarding dyspnea (Item 8): "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score is presented. The protocol specified final analysis for the first pembrolizumab course in Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.	Baseline and Week 24
TTD in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question regarding dyspnea (Item 8): "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in dyspnea (Item 8). TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.	Up to ~24 months
Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 is computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score is presented. The protocol specified final analysis for the first pembrolizumab course in Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.	Baseline and Week 24
TTD in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score	EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 is computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in physical functioning (Items 1 to 5). TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.	Up to ~24 months

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Gray JE, Schenker M, Sendur MAN, Leonova V, Kowalski D, Kato T, Orlova R, Yang JC, Langleben A, Pilz A, Ungureanu A, Mak MP, De Angelis F, Aggarwal H, Zimmer Z, Zhao B, Shamoun M, Kim TM. The Phase 3 KEYLYNK-006 Study of Pembrolizumab Plus Olaparib Versus Pembrolizumab Plus Pemetrexed as Maintenance Therapy for Metastatic Nonsquamous NSCLC. J Thorac Oncol. 2025 Feb;20(2):219-232. doi: 10.1016/j.jtho.2024.10.026. Epub 2024 Nov 7.

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2019
• Primary Completion (Actual): February 7, 2024
• Study Completion (Actual): January 29, 2026

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Programmed Cell Death-1 (PD1, PD-1); Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1); Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Parkinson Disease 4, Autosomal Dominant Lewy Body; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Platinum Compounds; Pemetrexed; Carboplatin; Cisplatin; pembrolizumab; olaparib
• Other Study ID Numbers: 7339-006; MK-7339-006 (Other Identifier: MSD); KEYLYNK-006 (Other Identifier: MSD); 194895 (Registry Identifier: JAPIC-CTI); 2018-004720-11 (EudraCT Number); U1111-1300-7107 (Registry Identifier: UTN); 2023-509774-40-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No