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)

September 6, 2023 updated by: Merck Sharp & Dohme LLC

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

The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs pembrolizumab plus maintenance pemetrexed for the treatment of nonsquamous 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 (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

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study has 2 phases: an Induction Phase (4 Cycles) and a Maintenance Phase (Up to 31 cycles of pembrolizumab). In the Induction Phase, participants receive pembrolizumab plus pemetrexed plus platinum (carboplatin or cisplatin). 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 plus maintenance olaparib OR maintenance pemetrexed until progressive disease (PD), intolerable toxicities, or physician decision.

Study Type

Interventional

Enrollment (Actual)

1005

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires ( Site 0511)
      • Cordoba, Argentina
        • Clínica Universitaria Reina Fabiola ( Site 0505)
      • Santa Fe, Argentina, S3000AOL
        • Sanatorio Privado San Geronimo S.R.L ( Site 0510)
    • Buenos Aires
      • Bahia Blanca, Buenos Aires, Argentina, B8001HXM
        • Hospital Italiano Regional del Sur ( Site 0509)
    • Caba
      • Buenos Aires, Caba, Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires ( Site 0500)
    • Cordoba
      • Rio Cuarto, Cordoba, Argentina, X5800AEV
        • Instituto Medico Rio Cuarto ( Site 0501)
    • Santa Fe
      • Rosario, Santa Fe, Argentina, Rosario
        • Centro Oncológico de Rosario ( Site 0507)
    • Tucuman
      • San Miguel de Tucuman, Tucuman, 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
      • Wien, Austria, 1210
        • Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)
    • Oberosterreich
      • Linz, Oberosterreich, Austria, 4020
        • Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)
      • Wels, Oberosterreich, Austria, 4600
        • Klinikum Wels-Grieskirchen ( Site 1304)
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Innsbruck LKH ( Site 1302)
    • Wien
      • Vienna, Wien, Austria, 1145
        • Social Medical Center - Otto Wagner Hospital ( Site 1301)
  • Brazil
      • Rio de Janeiro, Brazil, 20230-130
        • Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0203)
      • Sao Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0200)
      • Sao Paulo, Brazil, 01321-001
        • Hospital Paulistano - Amil Clinical Research ( Site 0207)
      • Sao Paulo, Brazil, 01321-001
        • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0214)
    • Bahia
      • Salvador, Bahia, Brazil, 41253-190
        • Hospital Sao Rafael ( Site 0212)
    • Ceara
      • Fortaleza, Ceara, Brazil, 60430-230
        • Instituto do Cancer do Ceara ( Site 0201)
    • Para
      • Belem, Para, Brazil, 66053-000
        • Oncologica do Brasil ( Site 0210)
    • Rio Grande Do Sul
      • Bento Goncalves, 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
      • Florianopolis, Santa Catarina, Brazil, 88020-210
        • YNOVA Pesquisa Clinica ( Site 0215)
      • Itajai, 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)
    • Sao Paulo
      • Sao Jose Rio Preto, Sao Paulo, Brazil, 15090-000
        • 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
      • Kitchener, Ontario, Canada, N2G 1G3
        • Grand River Hospital ( Site 0117)
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Stronach Regional Cancer Centre ( Site 0101)
      • Sudbury, Ontario, Canada, P3E 5J1
        • Health Sciences North Research Institute ( Site 0115)
    • 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 0C1
        • 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
      • Medellin, Antioquia, Colombia, 050030
        • Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0604)
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080020
        • Clinica de la Costa Ltda. ( Site 0608)
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 110221
        • Administradora Country S.A. ( Site 0603)
      • Bogota, Distrito Capital De Bogota, Colombia, 110311
        • Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0601)
  • France
    • 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)
    • Meurthe-et-Moselle
      • Vandoeuvre les Nancy, Meurthe-et-Moselle, France, 54519
        • Institut De Cancerologie De Lorraine ( Site 1409)
    • 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-Mande, Val-de-Marne, France, 94163
        • Hopital d'Instruction des Armees Begin ( Site 1413)
  • Germany
      • Hamburg, Germany, 22087
        • Katholisches Marienkrankenhaus gGmbH ( Site 1522)
    • Bayern
      • Aschaffenburg, Bayern, Germany, 63739
        • Studienzentrum Aschaffenburg ( Site 1525)
      • Muenchen, Bayern, Germany, 81925
        • Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1523)
      • Munich, Bayern, Germany, 80336
        • Klinikum der LMU ( Site 1500)
      • Regensburg, Bayern, Germany, 93053
        • Universitaetsklinikum Regensburg ( Site 1512)
      • Wuerzburg, Bayern, Germany, 97074
        • Klinikum Wuerzburg Mitte gGmbH ( Site 1509)
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Universitaetsklinikum Frankfurt ( Site 1513)
      • Immenhausen, Hessen, Germany, 34376
        • Pneumologische Lehrklinik Universitaet Goettingen ( Site 1501)
    • Niedersachsen
      • Goettingen, Niedersachsen, Germany, 37075
        • Universitaetsmedizin Goettingen ( Site 1507)
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53127
        • Universitaetsklinikum Bonn ( Site 1524)
      • Essen, Nordrhein-Westfalen, Germany, 45136
        • Kliniken Essen Mitte ( Site 1517)
    • Rheinland-Pfalz
      • Koblenz, Rheinland-Pfalz, Germany, 56068
        • InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1514)
    • Thuringen
      • Erfurt, Thuringen, Germany, 99089
        • Helios Klinikum Erfurt GmbH ( Site 1502)
  • Japan
      • Fukuoka, Japan, 810-8563
        • 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
        • The Cancer Institute Hospital of JFCR ( Site 0800)
    • Aichi
      • Nagoya, Aichi, Japan, 460-0001
        • National Hospital Organization Nagoya Medical Center ( Site 0806)
      • Nagoya, Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital ( Site 0803)
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East ( Site 0801)
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
        • Kanazawa University Hospital ( Site 0811)
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center ( Site 0807)
    • Miyagi
      • Sendai, Miyagi, Japan, 980-0873
        • 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
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center Hospital and Research Institute ( Site 0802)
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital ( Site 1000)
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital ( Site 1008)
    • Chungbuk
      • Cheongju si, Chungbuk, Korea, Republic of, 28644
        • Chungbuk National University Hospital ( Site 1002)
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, Korea, Republic of, 10408
        • National Cancer Center ( Site 1006)
      • Suwon, Kyonggi-do, Korea, Republic of, 16499
        • Ajou University Hospital ( Site 1004)
      • Suwon, Kyonggi-do, Korea, Republic of, 16247
        • The Catholic University of Korea St. Vincent s Hospital ( Site 1003)
    • Kyongsangnam-do
      • Jinju, Kyongsangnam-do, Korea, Republic of, 52727
        • Gyeongsang National University Hospital ( Site 1005)
    • Seoul
      • Songpa-gu, Seoul, Korea, Republic of, 05505
        • Asan Medical Center ( Site 1007)
  • 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
    • Dolnoslaskie
      • Zgorzelec, Dolnoslaskie, Poland, 59-900
        • Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)
    • Malopolskie
      • Krakow, Malopolskie, Poland, 31-202
        • Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
    • Slaskie
      • Raciborz, Slaskie, Poland, 47-400
        • Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)
    • Warminsko-mazurskie
      • Olsztyn, Warminsko-mazurskie, Poland, 10-357
        • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 2417)
    • Wielkopolskie
      • Konin, Wielkopolskie, Poland, 62-500
        • Przychodnia Lekarska Komed ( Site 2416)
      • Poznan, Wielkopolskie, Poland, 60-693
        • MED-POLONIA Sp. z o.o. ( Site 2419)
  • Romania
      • Brasov, Romania, 500152
        • Spitalul PDR Medlife ( Site 2509)
      • Bucuresti, Romania, 021389
        • S.C.Focus Lab Plus S.R.L ( Site 2502)
      • Constanta, Romania, 900591
        • Spitalul Clinic Judetean De Urgenta Constanta ( Site 2501)
    • Cluj
      • Cluj Napoca, Cluj, Romania, 400015
        • Cardiomed SRL Cluj-Napoca ( Site 2504)
      • Cluj-Napoca, Cluj, Romania, 407280
        • S.C. Radiotherapy Center Cluj S.R.L ( Site 2507)
    • Dolj
      • Craiova, Dolj, Romania, 200347
        • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2508)
    • Timis
      • Timisoara, Timis, Romania, 300239
        • Policlinica Oncomed SRL ( Site 2505)
  • Russian Federation
    • Leningradskaya Oblast
      • Saint Petersburg, Leningradskaya Oblast, Russian Federation, 194291
        • SBHI Leningrad Regional Clinical Hospital ( Site 2002)
    • Moskovskaya Oblast
      • Balashikha, Moskovskaya Oblast, Russian Federation, 143900
        • Moscow Regional Oncological Dispensary ( Site 2028)
    • Moskva
      • Moscow, Moskva, Russian Federation, 115478
        • Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 2000)
      • Moscow, Moskva, Russian Federation, 119991
        • First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024)
      • Moscow, Moskva, Russian Federation, 125284
        • Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009)
      • Moscow, Moskva, Russian Federation, 125367
        • FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006)
    • Nizhegorodskaya Oblast
      • Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603081
        • Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)
    • Omskaya Oblast
      • Omsk, Omskaya Oblast, Russian Federation, 644013
        • Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site
    • Samarskaya Oblast
      • Samara, Samarskaya Oblast, Russian Federation, 443031
        • SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 195271
        • SPb Central Clinical Railway Hospital ( Site 2003)
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197758
        • National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 2004)
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 198255
        • SPb SBHI City Clinical Oncological Dispensary ( Site 2001)
    • Tatarstan, Respublika
      • Kazan, Tatarstan, Respublika, Russian Federation, 420029
        • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2021)
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar ( Site 1702)
      • Sevilla, Spain, 41014
        • Hospital Universitario Nuestra Senora de Valme ( Site 1703)
      • Zaragoza, Spain, 50009
        • Hospital Clinico Lozano Blesa ( Site 1700)
    • Madrid
      • Pozuelo de Alarcon, 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, Taiwan, 833
        • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)
      • Taichung, Taiwan, 40447
        • China Medical University Hospital ( Site 0904)
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital ( Site 0905)
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital ( Site 0900)
      • Taipei, Taiwan, 104
        • Mackay Memorial Hospital ( Site 0902)
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation.Linkou Branch ( Site 0903)
  • Turkey
      • Adana, Turkey, 01120
        • Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 2101)
      • Ankara, Turkey, 06500
        • Gazi Universitesi Tip Fakultesi ( Site 2104)
      • Ankara, Turkey, 06800
        • Ankara Sehir Hastanesi ( Site 2105)
      • Istanbul, Turkey, 34093
        • Bezmialem Vakif Univ. Tıp Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107)
      • Istanbul, Turkey, 34722
        • Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2103)
      • Izmir, Turkey, 35040
        • Ege Universitesi Tip Fakultesi ( Site 2109)
      • Kayseri, Turkey, 38039
        • Erciyes Universitesi Tip Fakultesi ( Site 2108)
      • Samsun, Turkey, 55280
        • Samsun Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 2106)
    • Tekirdas
      • Tekirdag, Tekirdas, Turkey, 59100
        • Namik Kemal Universitesi Tip Fakultesi ( Site 2100)
  • Ukraine
      • Kyiv, Ukraine, 03039
        • Medical Center Verum ( Site 2230)
      • Kyiv, Ukraine, 03115
        • Kyiv City Clinical Oncology Centre ( Site 2210)
    • Cherkaska Oblast
      • Cherkasy, Cherkaska Oblast, Ukraine, 18009
        • Cherkasy Regional Oncology Dispensary ( Site 2211)
    • Dnipropetrovska Oblast
      • Dnipro, Dnipropetrovska Oblast, Ukraine, 49102
        • City Clinical Hosp.4 of DCC ( Site 2201)
    • Ivano-Frankivska Oblast
      • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76018
        • MI Precarpathian Clinical Oncology Center ( Site 2204)
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61024
        • Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2212)
      • Kharkiv, Kharkivska Oblast, Ukraine, 61070
        • Regional Centre of Oncology-Thoracic organs ( Site 2205)
    • Kirovohradska Oblast
      • Kropyvnitskiy, Kirovohradska Oblast, Ukraine, 25006
        • PP PPC Acinus Medical and Diagnostic Centre ( Site 2209)
    • Kyivska Oblast
      • Khodosivka, Kyivska Oblast, Ukraine, 08173
        • Medical Center Asklepion LLC ( Site 2234)
      • Kyiv, Kyivska Oblast, Ukraine, 03126
        • Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2213)
    • Odeska Oblast
      • Odesa, Odeska Oblast, Ukraine, 65055
        • MI Odessa Regional Oncological Centre ( Site 2208)
    • Zakarpatska Oblast
      • Uzhgorod, Zakarpatska Oblast, Ukraine, 88000
        • Central City Clinical Hospital ( Site 2207)
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital ( Site 1910)
      • Edinburg, United Kingdom, EH4 2XU
        • Western General Hospital, Edinburgh ( Site 1924)
      • Swansea, United Kingdom, SA2 8QA
        • Singleton Hospital ( Site 1909)
    • 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 Saint Edmunds, Suffolk, United Kingdom, IP33 2QZ
        • West Suffolk Hospitals NHS Trust ( Site 1919)
    • 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, 37804
        • Thompson Cancer Survival Center ( Site 2812)
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center Knoxville ( Site 0060)
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 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 not 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab + Pemetrexed + Platinum Therapy + Olaparib

For the Induction Phase, participants receive 4 cycles:

Pembrolizumab 200 mg intravenous (IV) on Day 1 of each 21-day cycle (cycles 1 through 4) PLUS Pemetrexed 500 mg/m^2 IV on Day 1 of each 21-day 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 21-day cycle (Cycles 1 through 4) OR cisplatin 75 mg/m^2 IV on Day 1 of 21-day cycle (Cycles 1 through 4).

If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy.

For the Maintenance Phase, participants receive Pembrolizumab IV on Day 1 of each 21-day cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib until progressive disease, physician decision or intolerable toxicity.
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
Tablets
Other Names:
  • LYNPARZA®
Active Comparator: Pembrolizumab + Pemetrexed + Platinum Therapy + Pemetrexed

For the Induction Phase, participants receive 4 cycles:

Pembrolizumab 200 mg intravenous (IV) on Day 1 of each 21-day cycle (cycles 1 through 4) PLUS Pemetrexed 500 mg/m^2 IV on Day 1 of each 21-day 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 21-day cycle (Cycles 1 through 4) OR cisplatin 75 mg/m^2 IV on Day 1 of 21-day cycle (Cycles 1 through 4). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive Pembrolizumab IV on Day 1 of each 21 day-cycle for up to 31 cycles PLUS maintenance pemetrexed IV 500 mg/m^2 on Day 1 of each 21-day cycle. In the Maintenance Phase, the participant continues to receive maintenance pemetrexed until progressive disease, physician decision or intolerable toxicity.
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
Overall Survival (OS)
Time Frame: Up to approximately 5 years
Overall survival is the time from the date of randomization to death due to any cause.
Up to approximately 5 years
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time Frame: Up to approximately 3 years
Progression-free survival is the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurs first.
Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline (at randomization) and Week 18 post-randomization
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scores will be presented.
Baseline (at randomization) and Week 18 post-randomization
Number of Participants Experiencing an Adverse Event (AE)
Time Frame: Up to approximately 5 years
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Up to approximately 5 years
Number of Participants Discontinuing Study Treatment Due to Adverse Event (AE)
Time Frame: Up to approximately 5 years
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Up to approximately 5 years
Change from Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
Time Frame: Baseline (at randomization) and Week 18 post-randomization
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "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 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score will be presented.
Baseline (at randomization) and Week 18 post-randomization
Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score
Time Frame: Baseline (at randomization) and Week 18 post-randomization
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How was your chest pain?" 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 will be presented.
Baseline (at randomization) and Week 18 post-randomization
Change from Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
Time Frame: Baseline (at randomization) and Week 18 post-randomization
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "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-LC13 dyspnea (Item 8) score will be presented.
Baseline (at randomization) and Week 18 post-randomization
Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
Time Frame: Baseline (at randomization) and Week 18 post-randomization
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning 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 higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented.
Baseline (at randomization) and Week 18 post-randomization
Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score
Time Frame: Up to approximately 5 years
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. TTD is defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 Items 29 and 30 scale scores.
Up to approximately 5 years
Time to True Deterioration (TTD) in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
Time Frame: Up to approximately 5 years
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "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 to 100. A lower score indicates a better outcome. TTD is defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in cough EORTC QLQ-LC13 cough (Item 1) scale score.
Up to approximately 5 years
Time to True Deterioration (TTD) in EORTC (QLQ-LC13 Chest Pain (Item 10) Scale Score
Time Frame: Up to approximately 5 years
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How was your chest pain?" 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 (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-LC13 chest pain (Item 10) scale score.
Up to approximately 5 years
Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
Time Frame: Up to approximately 5 years
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "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 (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 dyspnea (Item 8) scale score.
Up to approximately 5 years
Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
Time Frame: Up to approximately 5 years
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning 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 higher score indicates a better quality of life. TTD is defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 physical functioning (Items 1 to 5) scale scores.
Up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2019

Primary Completion (Estimated)

August 13, 2024

Study Completion (Estimated)

January 13, 2025

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)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7339-006
  • MK-7339-006 (Other Identifier: Merck Protocol Number)
  • KEYLYNK-006 (Other Identifier: Merck)
  • 194895 (Registry Identifier: JAPIC-CTI)
  • 2018-004720-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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