Carcinoma, Nonsquamous Non-small-cell LungPhase 3NCT03976323
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 testing Pembrolizumab, Pemetrexed and Carboplatin in people with Carcinoma, Nonsquamous Non-small-cell Lung, run by Merck Sharp & Dohme LLC at 178 sites in 20 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Nonsquamous Non-small-cell Lung
- What is being tested?
- Pembrolizumab, Pemetrexed and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,003 participants
- Where
- 178 sitesin 20 countries
- Study dates
- 28 Jun 2019to 30 Jan 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.
- Have stage IV nonsquamous NSCLC.
- Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is not indicated.
- Have measurable disease based on RECIST 1.1.
- 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.
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- Have a life expectancy of at least 3 months.
- 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.
- Have not received prior systemic treatment for their advanced/metastatic NSCLC.
- Have adequate organ function.
- 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.
- 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.
Who cannot join
- Has predominantly squamous cell histology NSCLC.
- Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has a known hypersensitivity to any components or excipients of cisplatin, carboplatin, pemetrexed, or olaparib.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
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- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
- Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.
- Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.
- Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
- 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).
- Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
- Has completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
Trial locations and contacts
178 sites in 20 countries.
178 sites in 20 countries
United States20 sites
Medstar Good Samaritan Hospital ( Site 0040)
Baltimore, Maryland, 21239
Frontier Oncology ( Site 0080)
Billings, Montana, 59102
Alabama Oncology Bruno Cancer Center ( Site 0001)
Birmingham, Alabama, 35205
Boca Raton Regional Hospital ( Site 0018)
Boca Raton, Florida, 33486
Bozeman Health Deaconness Cancer Center ( Site 0046)
Bozeman, Montana, 59715
Disney Family Cancer Center ( Site 0005)
Burbank, California, 91505
Waverly Hematology Oncology ( Site 0081)
Cary, North Carolina, 27518
Mount Sinai Hospital Medical Center ( Site 0032)
Chicago, Illinois, 60608
Columbus Regional Research Institute ( Site 0098)
Columbus, Georgia, 31904
Barbara Ann Karmanos Cancer Institute ( Site 0041)
Detroit, Michigan, 48201
Hattiesburg Clinic ( Site 0045)
Hattiesburg, Mississippi, 39401
Thompson Cancer Survival Center ( Site 2812)
Knoxville, Tennessee, 37916
University of Tennessee Medical Center Knoxville ( Site 0060)
Knoxville, Tennessee, 37920
Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0036)
Merrillville, Indiana, 46410
Northwest Alabama Cancer Center, PC ( Site 0002)
Muscle Shoals, Alabama, 35661
Mid-Florida Cancer Centers ( Site 0022)
Orange City, Florida, 32763
Oncology of Northshore ( Site 0033)
Rolling Meadows, Illinois, 60008
Cancer Care Northwest ( Site 0071)
Spokane Valley, Washington, 99216
Moffitt Cancer Center ( Site 0024)
Tampa, Florida, 33612
Renovatio Clinical ( Site 0062)
The Woodlands, Texas, 77380
Brazil14 sites
Oncologica do Brasil ( Site 0210)
Belém, Pará, 66053-000
Hospital Tacchini ( Site 0208)
Bento Gonçalves, Rio Grande do Sul, 95700-000
YNOVA Pesquisa Clinica ( Site 0215)
Florianópolis, Santa Catarina, 88020-210
Instituto do Cancer do Ceara ( Site 0201)
Fortaleza, Ceará, 60351-030
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0202)
Itajaí, Santa Catarina, 88301-220
Centro de Hematologia e Oncologia ( Site 0205)
Joinville, Santa Catarina, 89201-260
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0209)
Porto Alegre, Rio Grande do Sul, 90050-170
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0203)
Rio de Janeiro, 20231-050
Hospital Sao Rafael ( Site 0212)
Salvador, Estado de Bahia, 41253-190
Saint Gallen Instituto de Oncologia ( Site 0206)
Santa Cruz do Sul, Rio Grande do Sul, 96810-110
Hospital de Base de Sao Jose de Rio Preto ( Site 0204)
Sao Jose Rio Preto, São Paulo, 15080-000
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0200)
São Paulo, 01246-000
BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0214)
São Paulo, 01321-001
Hospital Paulistano - Amil Clinical Research ( Site 0207)
São Paulo, 01321-001
Japan14 sites
National Hospital Organization Kyushu Medical Center ( Site 0805)
Fukuoka, 8108563
Kansai Medical University Hospital ( Site 0804)
Hirakata, Osaka, 573-1191
Kanazawa University Hospital ( Site 0811)
Kanazawa, Ishikawa-ken, 920-8641
National Cancer Center Hospital East ( Site 0801)
Kashiwa, Chiba, 2778577
National Hospital Organization Nagoya Medical Center ( Site 0806)
Nagoya, Aichi-ken, 460-0001
Aichi Cancer Center ( Site 0803)
Nagoya, Aichi-ken, 464-8681
Niigata Cancer Center Hospital ( Site 0808)
Niigata, 951-8566
Okayama University Hospital ( Site 0810)
Okayama, 700-8558
Osaka International Cancer Institute ( Site 0809)
Osaka, 541-8567
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)
Sakai, Osaka, 591-8555
Sendai Kousei Hospital ( Site 0812)
Sendai, Miyagi, 981-0914
Shizuoka Cancer Center ( Site 0802)
Suntogun, Shizuoka, 411-8777
Cancer Institute Hospital of JFCR ( Site 0800)
Tokyo, 135-8550
Kanagawa Cancer Center ( Site 0807)
Yokohama, Kanagawa, 241-8515
Germany13 sites
Studienzentrum Aschaffenburg ( Site 1525)
Aschaffenburg, Bavaria, 63739
Universitaetsklinikum Bonn ( Site 1524)
Bonn, North Rhine-Westphalia, 53127
Helios Klinikum Erfurt GmbH ( Site 1502)
Erfurt, Thuringia, 99089
Kliniken Essen Mitte ( Site 1517)
Essen, North Rhine-Westphalia, 45136
Universitaetsklinikum Frankfurt ( Site 1513)
Frankfurt am Main, Hesse, 60590
Universitaetsmedizin Goettingen ( Site 1507)
Göttingen, Lower Saxony, 37075
Katholisches Marienkrankenhaus gGmbH ( Site 1522)
Hamburg, 22087
Pneumologische Lehrklinik Universitaet Goettingen ( Site 1501)
Immenhausen, Hesse, 34376
InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1514)
Koblenz, Rhineland-Palatinate, 56068
Klinikum der LMU ( Site 1500)
Munich, Bavaria, 80336
Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1523)
Munich, Bavaria, 81925
Universitaetsklinikum Regensburg ( Site 1512)
Regensburg, Bavaria, 93053
Klinikum Wuerzburg Mitte gGmbH ( Site 1509)
Würzburg, Bavaria, 97074
Russia13 sites
Moscow Regional Oncological Dispensary ( Site 2028)
Balashikha, Moscow Oblast, 143900
Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 2021)
Kazan', Tatarstan, Respublika, 420029
Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 2000)
Moscow, Moscow, 115478
First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024)
Moscow, Moscow, 119991
Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009)
Moscow, Moscow, 125284
FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006)
Moscow, Moscow, 125367
Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)
Nizhny Novgorod, Nizhny Novgorod Oblast, 603081
Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site 2010)
Omsk, Omsk Oblast, 644013
SBHI Leningrad Regional Clinical Hospital ( Site 2002)
Saint Petersburg, Sankt-Peterburg, 194291
SPb Central Clinical Railway Hospital ( Site 2003)
Saint Petersburg, Sankt-Peterburg, 195271
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 2004)
Saint Petersburg, Sankt-Peterburg, 197758
SPb SBHI City Clinical Oncological Dispensary ( Site 2001)
Saint Petersburg, Sankt-Peterburg, 198255
SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)
Samara, Samara Oblast, 443031
Ukraine12 sites
Cherkasy Regional Oncology Dispensary ( Site 2211)
Cherkasy, Cherkasy Oblast, 18009
Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 2201)
Dnipro, Dnipropetrovsk Oblast, 49102
MI Precarpathian Clinical Oncology Center ( Site 2204)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2212)
Kharkiv, Kharkiv Oblast, 61024
CNPE "Regional Center of Oncology"-Thoracic organs ( Site 2205)
Kharkiv, Kharkiv Oblast, 61070
Medical Center Asklepion LLC ( Site 2234)
Khodosovka, Kyivska Oblast, 08173
PP PPC Acinus Medical and Diagnostic Centre ( Site 2209)
Kropyvnitskiy, Kirovohrad Oblast, 25006
Medical Center Verum ( Site 2230)
Kyiv, Kyivska Oblast, 03039
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2213)
Kyiv, Kyivska Oblast, 03126
Kyiv City Clinical Oncology Centre ( Site 2210)
Kyiv, 03115
MI Odessa Regional Oncological Centre ( Site 2208)
Odesa, Odesa Oblast, 65055
Central City Clinical Hospital ( Site 2207)
Uzhhorod, Zakarpattia Oblast, 88000
Canada11 sites
Health Sciences North Research Institute ( Site 0115)
Greater Sudbury, Ontario, P3E 5J1
CISSS de la Monteregie-Centre ( Site 0114)
Greenfield Park, Quebec, J4V 2H1
Queen Elizabeth II Health Sciences Centre ( Site 0107)
Halifax, Nova Scotia, B3H 2Y9
Waterloo Regional Health Network (WRHN) ( Site 0117)
Kitchener, Ontario, N2G 1G3
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0105)
Montreal, Quebec, H2X 3E4
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)
Montreal, Quebec, H3T 1M5
Stronach Regional Cancer Centre ( Site 0101)
Newmarket, Ontario, L3Y 2P9
Lions Gate Hospital ( Site 0106)
North Vancouver, British Columbia, V7L 2L7
Centre de Sante et des Services Sociaux de Rimouski-Neigette ( Site 0104)
Rimouski, Quebec, G5L 5T1
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103)
Sherbrooke, Quebec, J1H 5N4
BC Cancer - Victoria ( Site 0109)
Victoria, British Columbia, V8R 6V5
France9 sites
CHU Angers ( Site 1405)
Angers, Maine-et-Loire, 49100
CHU Caen ( Site 1406)
Caen, Calvados, 14033
Centre Hospitalier De Chauny ( Site 1411)
Chauny, Aisne, 02300
Centre Jean Perrin ( Site 1407)
Clermont-Ferrand, Puy-de-Dome, 63011
Centre Hospitalier de Pau ( Site 1412)
Pau, Pyrenees-Atlantiques, 64000
CHU de Rouen ( Site 1403)
Rouen, Seine-Maritime, 76000
Hopital d'Instruction des Armees Begin ( Site 1413)
Saint-Mandé, Val-de-Marne, 94163
Institut De Cancerologie De Lorraine ( Site 1409)
Vandœuvre-lès-Nancy, Ain, 54519
Hopital Robert Schuman ( Site 1402)
Vantoux, Moselle, 57070
Turkey (Türkiye)9 sites
Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 2101)
Adana, 01120
Gazi Universitesi Tip Fakultesi ( Site 2104)
Ankara, 06500
Ankara Bilkent Sehir Hastanesi ( Site 2105)
Ankara, 06800
Bezmialem Vakif Univ. Tıp Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107)
Istanbul, 34093
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2103)
Istanbul, 34722
Ege Universitesi Tip Fakultesi ( Site 2109)
Izmir, 35040
Erciyes Universitesi Tip Fakultesi ( Site 2108)
Kayseri, 38039
Ondokuz Mayıs Universitesi-Oncology department ( Site 2106)
Samsun, 55139
Namik Kemal Universitesi Tip Fakultesi ( Site 2100)
Tekirdağ, Tekirdas, 59100
Argentina8 sites
Hospital Italiano Regional del Sur ( Site 0509)
Bahía Blanca, Buenos Aires, B8001HXM
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0511)
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB
Hospital Britanico de Buenos Aires ( Site 0500)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB
Clínica Universitaria Reina Fabiola ( Site 0505)
Córdoba, X5004SHP
Instituto Medico Rio Cuarto ( Site 0501)
Río Cuarto, Córdoba Province, X5800AEV
Centro Oncológico de Rosario ( Site 0507)
Rosario, Santa Fe Province, S2000KZE
Centro Medico San Roque ( Site 0506)
San Miguel de Tucumán, Tucumán Province, T4000IAK
Sanatorio Privado San Geronimo S.R.L ( Site 0510)
Santa Fe, S3000AOL
South Korea8 sites
Chungbuk National University Hospital ( Site 1002)
Cheongju-si, North Chungcheong, 28644
National Cancer Center ( Site 1006)
Goyang-si, Kyonggi-do, 10408
Gyeongsang National University Hospital ( Site 1005)
Jinju, Kyongsangnam-do, 52727
Seoul National University Hospital ( Site 1000)
Seoul, 03080
Korea University Guro Hospital ( Site 1008)
Seoul, 08308
Asan Medical Center ( Site 1007)
Songpa-gu, Seoul, 05505
The Catholic University of Korea St. Vincent s Hospital ( Site 1003)
Suwon, Kyonggi-do, 16247
Ajou University Hospital ( Site 1004)
Suwon, Kyonggi-do, 16499
Poland7 sites
Przychodnia Lekarska Komed ( Site 2416)
Konin, Greater Poland Voivodeship, 62-500
Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)
Krakow, Lesser Poland Voivodeship, 31-202
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie ( Site 2417)
Olsztyn, Warmian-Masurian Voivodeship, 10-357
MED-POLONIA Sp. z o.o. ( Site 2419)
Poznan, Greater Poland Voivodeship, 61-693
Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)
Racibórz, Silesian Voivodeship, 47-400
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2418)
Warsaw, Masovian Voivodeship, 02-781
Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)
Zgorzelec, Lower Silesian Voivodeship, 59-900
Romania7 sites
Spitalul PDR Medlife ( Site 2509)
Brasov, 500152
MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 2502)
Bucharest, Bucharest, 013823
Cardiomed SRL Cluj-Napoca ( Site 2504)
Cluj-Napoca, Cluj, 400015
S.C. Radiotherapy Center Cluj S.R.L ( Site 2507)
Cluj-Napoca, Cluj, 407280
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2508)
Craiova, Dolj, 200542
Ovidius Clinical Hospital OCH ( Site 2501)
Ovidiu, Constanța County, 905900
Policlinica Oncomed SRL ( Site 2505)
Timișoara, Timiș County, 300239
United Kingdom7 sites
Birmingham Heartlands Hospital ( Site 1910)
Birmingham, B9 5SS
West Suffolk Hospitals NHS Trust ( Site 1919)
Bury St Edmunds, Suffolk, IP33 2QZ
Colchester General Hospital ( Site 1911)
Colchester, Worcestershire, CO4 5JL
Western General Hospital, Edinburgh ( Site 1924)
Edinburgh, United Kingdom, EH4 2XU
Barts Health NHS Trust - St Bartholomew s Hospital ( Site 1923)
London, London, City of, EC1M 6BQ
Chelsea and Westminster Hospital ( Site 1901)
London, London, City of, SW10 9NH
Singleton Hospital ( Site 1909)
Swansea, Wales, SA2 8QA
Taiwan6 sites
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)
Kaohsiung City, 833
China Medical University Hospital ( Site 0904)
Taichung, 40447
National Cheng Kung University Hospital ( Site 0905)
Tainan, 70457
National Taiwan University Hospital ( Site 0900)
Taipei, 100
Mackay Memorial Hospital ( Site 0902)
Taipei, 104
Chang Gung Medical Foundation.Linkou Branch ( Site 0903)
Taoyuan, 333
Austria5 sites
Innsbruck LKH ( Site 1302)
Innsbruck, Tyrol, 6020
Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)
Linz, Upper Austria, 4020
Social Medical Center - Otto Wagner Hospital ( Site 1301)
Vienna, State of Vienna, 1145
Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)
Vienna, 1210
Klinikum Wels-Grieskirchen ( Site 1304)
Wels, Upper Austria, 4600
Spain5 sites
Hospital del Mar ( Site 1702)
Barcelona, 08003
Hospital Universitario Quiron Madrid ( Site 1701)
Pozuelo de Alarcón, Madrid, 28223
Hospital Universitario Nuestra Senora de Valme ( Site 1703)
Seville, 41014
Hospital Clinico Universitario de Valencia ( Site 1706)
Valencia, Valenciana, Comunitat, 46010
Hospital Clinico Lozano Blesa ( Site 1700)
Zaragoza, 50009
Australia4 sites
Monash Cancer Centre ( Site 1205)
Clayton, Victoria, 3168
Liverpool Hospital ( Site 1201)
Liverpool, New South Wales, 2170
Townsville General Hospital ( Site 1202)
Townsville, Queensland, 4814
Southern Medical Day Care Centre ( Site 1200)
Wollongong, New South Wales, 2500
Colombia4 sites
Clinica de la Costa S.A.S. ( Site 0608)
Barranquilla, Atlántico, 080020
Administradora Country S.A. ( Site 0603)
Bogotá, Bogota D.C., 110221
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0601)
Bogotá, Bogota D.C., 111321
Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0604)
Medellín, Antioquia, 050030
New Zealand2 sites
MidCentral DHB Palmerston North Hospital ( Site 1102)
Palmerston North, Manawatu-Wanganui, 4414
Capital & Coast District Health Board - Wellington Hospital ( Site 1101)
Wellington, 6021
About this study
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)
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).
Read the 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.
- Being tested
- Pembrolizumab, Pemetrexed, Carboplatin, Cisplatin, Olaparib
- 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)
- Medical subject headings
- Carcinoma, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabBiological
Also called MK-3475, KEYTRUDA®
IV infusion
PemetrexedDrug
Also called ALIMTA®
IV infusion
CarboplatinDrug
Also called PARAPLATIN®
IV infusion
CisplatinDrug
Also called PLATINOL®, PLATINOL®-AQ
IV infusion
OlaparibDrug
Also called LYNPARZA®
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab + Pemetrexed + Platinum Therapy + Olaparib | Experimental | 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]). Receives: Biological: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin; Drug: Olaparib |
| Pembrolizumab + Pemetrexed + Platinum Therapy + Pemetrexed | Active comparator | 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]). Receives: Biological: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to ~51 months
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to ~24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start28 Jun 2019
- Primary completion7 Feb 2024
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Nonsquamous Non-small-cell LungStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976323
- Sponsor's protocol ID
- 7339-006
- Other IDs
- MK-7339-006, KEYLYNK-006, 194895, 2023-509774-40-00, U1111-1300-7107, 2018-004720-11, 2018, 2023
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2019
- Last updated
- 28 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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.
PubMed 39521434