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)

NCT03976323 | Completed Phase 3 Results DMC FDA Drug

• 7 other identifiers: 7339-006MK-7339-006KEYLYNK-0061948952023-509774-40-00U1111-1300-71072018-004720-11
• Study Type: interventional
• Target: 1,003
• Locations: 19 countries
• Sites: 174

Brief Summary

The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, versus (vs) pembrolizumab plus maintenance pemetrexed for the treatment of non-squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).

Conditions

Carcinoma, Nonsquamous Non-small-cell Lung

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)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Number of Participants Who Experience One or More Adverse Events (AEs)

  Up to ~5 years

• Number of Participants Who Discontinue Study Treatment Due to an AE

  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

  Baseline and Week 24

• Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score

  Up to ~24 months

• Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score

  Baseline and Week 24

Study Arms (2)

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 \[cycle = 3 weeks\]).

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 \[cycle = 3 weeks\]).

Biological: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin

Interventions

Pembrolizumab BIOLOGICAL

IV infusion

Also known as: MK-3475, KEYTRUDA®

Pembrolizumab + Pemetrexed + Platinum Therapy + Olaparib; Pembrolizumab + Pemetrexed + Platinum Therapy + Pemetrexed

Pemetrexed DRUG

IV infusion

Also known as: ALIMTA®

Pembrolizumab + Pemetrexed + Platinum Therapy + Olaparib; Pembrolizumab + Pemetrexed + Platinum Therapy + Pemetrexed

Carboplatin DRUG

IV infusion

Also known as: PARAPLATIN®

Pembrolizumab + Pemetrexed + Platinum Therapy + Olaparib; Pembrolizumab + Pemetrexed + Platinum Therapy + Pemetrexed

Cisplatin DRUG

IV infusion

Also known as: PLATINOL®, PLATINOL®-AQ

Pembrolizumab + Pemetrexed + Platinum Therapy + Olaparib; Pembrolizumab + Pemetrexed + Platinum Therapy + Pemetrexed

Olaparib DRUG

Oral Tablet

Also known as: LYNPARZA®

Pembrolizumab + Pemetrexed + Platinum Therapy + Olaparib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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 history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
• Has completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (178)

Alabama Oncology Bruno Cancer Center ( Site 0001)

Birmingham, Alabama, 35205, United States

Location

Northwest Alabama Cancer Center, PC ( Site 0002)

Muscle Shoals, Alabama, 35661, United States

Location

Disney Family Cancer Center ( Site 0005)

Burbank, California, 91505, United States

Location

Boca Raton Regional Hospital ( Site 0018)

Boca Raton, Florida, 33486, United States

Location

Mid-Florida Cancer Centers ( Site 0022)

Orange City, Florida, 32763, United States

Location

Moffitt Cancer Center ( Site 0024)

Tampa, Florida, 33612, United States

Location

Columbus Regional Research Institute ( Site 0098)

Columbus, Georgia, 31904, United States

Location

Mount Sinai Hospital Medical Center ( Site 0032)

Chicago, Illinois, 60608, United States

Location

Oncology of Northshore ( Site 0033)

Rolling Meadows, Illinois, 60008, United States

Location

Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0036)

Merrillville, Indiana, 46410, United States

Location

Medstar Good Samaritan Hospital ( Site 0040)

Baltimore, Maryland, 21239, United States

Location

Barbara Ann Karmanos Cancer Institute ( Site 0041)

Detroit, Michigan, 48201, United States

Location

Hattiesburg Clinic ( Site 0045)

Hattiesburg, Mississippi, 39401, United States

Location

Frontier Oncology ( Site 0080)

Billings, Montana, 59102, United States

Location

Bozeman Health Deaconness Cancer Center ( Site 0046)

Bozeman, Montana, 59715, United States

Location

Waverly Hematology Oncology ( Site 0081)

Cary, North Carolina, 27518, United States

Location

Thompson Cancer Survival Center ( Site 2812)

Knoxville, Tennessee, 37916, United States

Location

University of Tennessee Medical Center Knoxville ( Site 0060)

Knoxville, Tennessee, 37920, United States

Location

Renovatio Clinical ( Site 0062)

The Woodlands, Texas, 77380, United States

Location

Cancer Care Northwest ( Site 0071)

Spokane Valley, Washington, 99216, United States

Location

Hospital Italiano Regional del Sur ( Site 0509)

Bahía Blanca, Buenos Aires, B8001HXM, Argentina

Location

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0511)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina

Location

Hospital Britanico de Buenos Aires ( Site 0500)

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB, Argentina

Location

Instituto Medico Rio Cuarto ( Site 0501)

Río Cuarto, Córdoba Province, X5800AEV, Argentina

Location

Centro Oncológico de Rosario ( Site 0507)

Rosario, Santa Fe Province, S2000KZE, Argentina

Location

Centro Medico San Roque ( Site 0506)

San Miguel de Tucumán, Tucumán Province, T4000IAK, Argentina

Location

Clínica Universitaria Reina Fabiola ( Site 0505)

Córdoba, X5004SHP, Argentina

Location

Sanatorio Privado San Geronimo S.R.L ( Site 0510)

Santa Fe, S3000AOL, Argentina

Location

Liverpool Hospital ( Site 1201)

Liverpool, New South Wales, 2170, Australia

Location

Southern Medical Day Care Centre ( Site 1200)

Wollongong, New South Wales, 2500, Australia

Location

Townsville General Hospital ( Site 1202)

Townsville, Queensland, 4814, Australia

Location

Monash Cancer Centre ( Site 1205)

Clayton, Victoria, 3168, Australia

Location

Innsbruck LKH ( Site 1302)

Innsbruck, Tyrol, 6020, Austria

Location

Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)

Linz, Upper Austria, 4020, Austria

Location

Klinikum Wels-Grieskirchen ( Site 1304)

Wels, Upper Austria, 4600, Austria

Location

Social Medical Center - Otto Wagner Hospital ( Site 1301)

Vienna, Vienna, 1145, Austria

Location

Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)

Vienna, 1210, Austria

Location

Instituto do Cancer do Ceara ( Site 0201)

Fortaleza, Ceará, 60351-030, Brazil

Location

Hospital Sao Rafael ( Site 0212)

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Oncologica do Brasil ( Site 0210)

Belém, Pará, 66053-000, Brazil

Location

Hospital Tacchini ( Site 0208)

Bento Gonçalves, Rio Grande do Sul, 95700-000, Brazil

Location

Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0209)

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

Saint Gallen Instituto de Oncologia ( Site 0206)

Santa Cruz do Sul, Rio Grande do Sul, 96810-110, Brazil

Location

YNOVA Pesquisa Clinica ( Site 0215)

Florianópolis, Santa Catarina, 88020-210, Brazil

Location

Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0202)

Itajaí, Santa Catarina, 88301-220, Brazil

Location

Centro de Hematologia e Oncologia ( Site 0205)

Joinville, Santa Catarina, 89201-260, Brazil

Location

Hospital de Base de Sao Jose de Rio Preto ( Site 0204)

Sao Jose Rio Preto, São Paulo, 15080-000, Brazil

Location

Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0203)

Rio de Janeiro, 20231-050, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0200)

São Paulo, 01246-000, Brazil

Location

BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0214)

São Paulo, 01321-001, Brazil

Location

Hospital Paulistano - Amil Clinical Research ( Site 0207)

São Paulo, 01321-001, Brazil

Location

Lions Gate Hospital ( Site 0106)

North Vancouver, British Columbia, V7L 2L7, Canada

Location

BC Cancer - Victoria ( Site 0109)

Victoria, British Columbia, V8R 6V5, Canada

Location

Queen Elizabeth II Health Sciences Centre ( Site 0107)

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Health Sciences North Research Institute ( Site 0115)

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Waterloo Regional Health Network (WRHN) ( Site 0117)

Kitchener, Ontario, N2G 1G3, Canada

Location

Stronach Regional Cancer Centre ( Site 0101)

Newmarket, Ontario, L3Y 2P9, Canada

Location

CISSS de la Monteregie-Centre ( Site 0114)

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0105)

Montreal, Quebec, H2X 3E4, Canada

Location

CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)

Montreal, Quebec, H3T 1M5, Canada

Location

Centre de Sante et des Services Sociaux de Rimouski-Neigette ( Site 0104)

Rimouski, Quebec, G5L 5T1, Canada

Location

CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103)

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0604)

Medellín, Antioquia, 050030, Colombia

Location

Clinica de la Costa S.A.S. ( Site 0608)

Barranquilla, Atlántico, 080020, Colombia

Location

Administradora Country S.A. ( Site 0603)

Bogotá, Bogota D.C., 110221, Colombia

Location

Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0601)

Bogotá, Bogota D.C., 111321, Colombia

Location

Institut De Cancerologie De Lorraine ( Site 1409)

Vandœuvre-lès-Nancy, Ain, 54519, France

Location

Centre Hospitalier De Chauny ( Site 1411)

Chauny, Aisne, 02300, France

Location

CHU Caen ( Site 1406)

Caen, Calvados, 14033, France

Location

CHU Angers ( Site 1405)

Angers, Maine-et-Loire, 49100, France

Location

Hopital Robert Schuman ( Site 1402)

Vantoux, Moselle, 57070, France

Location

Centre Jean Perrin ( Site 1407)

Clermont-Ferrand, Puy-de-Dome, 63011, France

Location

Centre Hospitalier de Pau ( Site 1412)

Pau, Pyrenees-Atlantiques, 64000, France

Location

CHU de Rouen ( Site 1403)

Rouen, Seine-Maritime, 76000, France

Location

Hopital d'Instruction des Armees Begin ( Site 1413)

Saint-Mandé, Val-de-Marne, 94163, France

Location

Studienzentrum Aschaffenburg ( Site 1525)

Aschaffenburg, Bavaria, 63739, Germany

Location

Klinikum der LMU ( Site 1500)

Munich, Bavaria, 80336, Germany

Location

Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1523)

Munich, Bavaria, 81925, Germany

Location

Universitaetsklinikum Regensburg ( Site 1512)

Regensburg, Bavaria, 93053, Germany

Location

Klinikum Wuerzburg Mitte gGmbH ( Site 1509)

Würzburg, Bavaria, 97074, Germany

Location

Universitaetsklinikum Frankfurt ( Site 1513)

Frankfurt am Main, Hesse, 60590, Germany

Location

Pneumologische Lehrklinik Universitaet Goettingen ( Site 1501)

Immenhausen, Hesse, 34376, Germany

Location

Universitaetsmedizin Goettingen ( Site 1507)

Göttingen, Lower Saxony, 37075, Germany

Location

Universitaetsklinikum Bonn ( Site 1524)

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Kliniken Essen Mitte ( Site 1517)

Essen, North Rhine-Westphalia, 45136, Germany

Location

InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1514)

Koblenz, Rhineland-Palatinate, 56068, Germany

Location

Helios Klinikum Erfurt GmbH ( Site 1502)

Erfurt, Thuringia, 99089, Germany

Location

Katholisches Marienkrankenhaus gGmbH ( Site 1522)

Hamburg, 22087, Germany

Location

National Hospital Organization Nagoya Medical Center ( Site 0806)

Nagoya, Aichi-ken, 460-0001, Japan

Location

Aichi Cancer Center ( Site 0803)

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East ( Site 0801)

Kashiwa, Chiba, 2778577, Japan

Location

Kanazawa University Hospital ( Site 0811)

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Kanagawa Cancer Center ( Site 0807)

Yokohama, Kanagawa, 241-8515, Japan

Location

Sendai Kousei Hospital ( Site 0812)

Sendai, Miyagi, 981-0914, Japan

Location

Kansai Medical University Hospital ( Site 0804)

Hirakata, Osaka, 573-1191, Japan

Location

National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)

Sakai, Osaka, 591-8555, Japan

Location

Shizuoka Cancer Center ( Site 0802)

Suntogun, Shizuoka, 411-8777, Japan

Location

National Hospital Organization Kyushu Medical Center ( Site 0805)

Fukuoka, 8108563, Japan

Location

Niigata Cancer Center Hospital ( Site 0808)

Niigata, 951-8566, Japan

Location

Okayama University Hospital ( Site 0810)

Okayama, 700-8558, Japan

Location

Osaka International Cancer Institute ( Site 0809)

Osaka, 541-8567, Japan

Location

Cancer Institute Hospital of JFCR ( Site 0800)

Tokyo, 135-8550, Japan

Location

MidCentral DHB Palmerston North Hospital ( Site 1102)

Palmerston North, Manawatu-Wanganui, 4414, New Zealand

Location

Capital & Coast District Health Board - Wellington Hospital ( Site 1101)

Wellington, 6021, New Zealand

Location

Przychodnia Lekarska Komed ( Site 2416)

Konin, Greater Poland Voivodeship, 62-500, Poland

Location

MED-POLONIA Sp. z o.o. ( Site 2419)

Poznan, Greater Poland Voivodeship, 61-693, Poland

Location

Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)

Krakow, Lesser Poland Voivodeship, 31-202, Poland

Location

Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)

Zgorzelec, Lower Silesian Voivodeship, 59-900, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2418)

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)

Racibórz, Silesian Voivodeship, 47-400, Poland

Location

Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie ( Site 2417)

Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland

Location

MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 2502)

Bucharest, București, 013823, Romania

Location

Cardiomed SRL Cluj-Napoca ( Site 2504)

Cluj-Napoca, Cluj, 400015, Romania

Location

S.C. Radiotherapy Center Cluj S.R.L ( Site 2507)

Cluj-Napoca, Cluj, 407280, Romania

Location

Ovidius Clinical Hospital OCH ( Site 2501)

Ovidiu, Constanța County, 905900, Romania

Location

S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2508)

Craiova, Dolj, 200542, Romania

Location

Policlinica Oncomed SRL ( Site 2505)

Timișoara, Timiș County, 300239, Romania

Location

Spitalul PDR Medlife ( Site 2509)

Brasov, 500152, Romania

Location

Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 2000)

Moscow, Moscow, 115478, Russia

Location

First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024)

Moscow, Moscow, 119991, Russia

Location

Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009)

Moscow, Moscow, 125284, Russia

Location

FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006)

Moscow, Moscow, 125367, Russia

Location

Moscow Regional Oncological Dispensary ( Site 2028)

Balashikha, Moscow Oblast, 143900, Russia

Location

Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)

Nizhny Novgorod, Nizhny Novgorod Oblast, 603081, Russia

Location

Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site 2010)

Omsk, Omsk Oblast, 644013, Russia

Location

SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)

Samara, Samara Oblast, 443031, Russia

Location

SBHI Leningrad Regional Clinical Hospital ( Site 2002)

Saint Petersburg, Sankt-Peterburg, 194291, Russia

Location

SPb Central Clinical Railway Hospital ( Site 2003)

Saint Petersburg, Sankt-Peterburg, 195271, Russia

Location

National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 2004)

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

SPb SBHI City Clinical Oncological Dispensary ( Site 2001)

Saint Petersburg, Sankt-Peterburg, 198255, Russia

Location

Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 2021)

Kazan', Tatarstan, Respublika, 420029, Russia

Location

National Cancer Center ( Site 1006)

Goyang-si, Kyonggi-do, 10408, South Korea

Location

The Catholic University of Korea St. Vincent s Hospital ( Site 1003)

Suwon, Kyonggi-do, 16247, South Korea

Location

Ajou University Hospital ( Site 1004)

Suwon, Kyonggi-do, 16499, South Korea

Location

Gyeongsang National University Hospital ( Site 1005)

Jinju, Kyongsangnam-do, 52727, South Korea

Location

Chungbuk National University Hospital ( Site 1002)

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Asan Medical Center ( Site 1007)

Songpa-gu, Seoul, 05505, South Korea

Location

Seoul National University Hospital ( Site 1000)

Seoul, 03080, South Korea

Location

Korea University Guro Hospital ( Site 1008)

Seoul, 08308, South Korea

Location

Hospital Universitario Quiron Madrid ( Site 1701)

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Clinico Universitario de Valencia ( Site 1706)

Valencia, Valenciana, Comunitat, 46010, Spain

Location

Hospital del Mar ( Site 1702)

Barcelona, 08003, Spain

Location

Hospital Universitario Nuestra Senora de Valme ( Site 1703)

Seville, 41014, Spain

Location

Hospital Clinico Lozano Blesa ( Site 1700)

Zaragoza, 50009, Spain

Location

Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)

Kaohsiung City, 833, Taiwan

Location

China Medical University Hospital ( Site 0904)

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital ( Site 0905)

Tainan, 70457, Taiwan

Location

National Taiwan University Hospital ( Site 0900)

Taipei, 100, Taiwan

Location

Mackay Memorial Hospital ( Site 0902)

Taipei, 104, Taiwan

Location

Chang Gung Medical Foundation.Linkou Branch ( Site 0903)

Taoyuan District, 333, Taiwan

Location

Namik Kemal Universitesi Tip Fakultesi ( Site 2100)

Tekirdağ, Tekirdas, 59100, Turkey (Türkiye)

Location

Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 2101)

Adana, 01120, Turkey (Türkiye)

Location

Gazi Universitesi Tip Fakultesi ( Site 2104)

Ankara, 06500, Turkey (Türkiye)

Location

Ankara Bilkent Sehir Hastanesi ( Site 2105)

Ankara, 06800, Turkey (Türkiye)

Location

Bezmialem Vakif Univ. Tıp Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107)

Istanbul, 34093, Turkey (Türkiye)

Location

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2103)

Istanbul, 34722, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi ( Site 2109)

Izmir, 35040, Turkey (Türkiye)

Location

Erciyes Universitesi Tip Fakultesi ( Site 2108)

Kayseri, 38039, Turkey (Türkiye)

Location

Ondokuz Mayıs Universitesi-Oncology department ( Site 2106)

Samsun, 55139, Turkey (Türkiye)

Location

Cherkasy Regional Oncology Dispensary ( Site 2211)

Cherkasy, Cherkasy Oblast, 18009, Ukraine

Location

Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 2201)

Dnipro, Dnipropetrovsk Oblast, 49102, Ukraine

Location

MI Precarpathian Clinical Oncology Center ( Site 2204)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

Location

Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2212)

Kharkiv, Kharkivs’ka Oblast’, 61024, Ukraine

Location

CNPE "Regional Center of Oncology"-Thoracic organs ( Site 2205)

Kharkiv, Kharkivs’ka Oblast’, 61070, Ukraine

Location

PP PPC Acinus Medical and Diagnostic Centre ( Site 2209)

Kropyvnitskiy, Kirovohrad Oblast, 25006, Ukraine

Location

Medical Center Asklepion LLC ( Site 2234)

Khodosovka, Kyivska Oblast, 08173, Ukraine

Location

Medical Center Verum ( Site 2230)

Kyiv, Kyivska Oblast, 03039, Ukraine

Location

Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2213)

Kyiv, Kyivska Oblast, 03126, Ukraine

Location

MI Odessa Regional Oncological Centre ( Site 2208)

Odesa, Odesa Oblast, 65055, Ukraine

Location

Central City Clinical Hospital ( Site 2207)

Uzhhorod, Zakarpattia Oblast, 88000, Ukraine

Location

Kyiv City Clinical Oncology Centre ( Site 2210)

Kyiv, 03115, Ukraine

Location

Barts Health NHS Trust - St Bartholomew s Hospital ( Site 1923)

London, London, City of, EC1M 6BQ, United Kingdom

Location

Chelsea and Westminster Hospital ( Site 1901)

London, London, City of, SW10 9NH, United Kingdom

Location

West Suffolk Hospitals NHS Trust ( Site 1919)

Bury St Edmunds, Suffolk, IP33 2QZ, United Kingdom

Location

Western General Hospital, Edinburgh ( Site 1924)

Edinburgh, United Kingdom, EH4 2XU, United Kingdom

Location

Singleton Hospital ( Site 1909)

Swansea, Wales, SA2 8QA, United Kingdom

Location

Colchester General Hospital ( Site 1911)

Colchester, Worcestershire, CO4 5JL, United Kingdom

Location

Birmingham Heartlands Hospital ( Site 1910)

Birmingham, B9 5SS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39521434 RESULT

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; Pemetrexed; Carboplatin; Cisplatin; olaparib

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 6, 2019
• Study Start: June 28, 2019
• Primary Completion: February 7, 2024
• Study Completion: January 29, 2026
• Last Updated: February 25, 2026
• Results First Posted: February 6, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

DE (13); RU (13); AR (8); CA (11); ES (5); CO (4); BR (14); GB (7); JP (14); US (20); AU (5); FR (9); TU (9); PL (7); UA (12); NZ (2); RO (7); KR (8); TW (6)