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)

NCT ID: NCT03976323

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1003 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-28
• Study Completion Date: 2026-01-30

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).

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.

Conditions

Carcinoma, Nonsquamous Non-small-cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pembrolizumab + Pemetrexed + Platinum Therapy + Olaparib

For the Induction Phase, participants receive 4 cycles (up to ~12 weeks [cycle = 3 weeks]): pembrolizumab 200 mg intravenous (IV) on Day 1 of each cycle (cycles 1 through 4) PLUS pemetrexed 500 mg/m^2 IV on Day 1 of each cycle (cycles 1 through 4) PLUS platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of each cycle (Cycles 1 through 4) OR cisplatin 75 mg/m^2 IV on Day 1 of each cycle (Cycles 1 through 4).

If the participant has a complete/partial response or stable disease to induction therapy, the participant can enter the Maintenance Phase and receive pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. The participant can continue to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants can receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]).

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: BIOLOGICAL

IV infusion

Pemetrexed

Intervention Type: DRUG

IV infusion

Carboplatin

Intervention Type: DRUG

IV infusion

Cisplatin

Intervention Type: DRUG

IV infusion

Olaparib

Intervention Type: DRUG

Oral Tablet

Pembrolizumab + Pemetrexed + Platinum Therapy + Pemetrexed

For the Induction Phase, participants receive 4 cycles (up to ~12 weeks [cycle = 3 weeks]): pembrolizumab 200 mg IV on Day 1 of each cycle (cycles 1 through 4) PLUS pemetrexed 500 mg/m^2 IV on Day 1 of each cycle (cycles 1 through 4) PLUS platinum chemotherapy, investigator's choice: carboplatin AUC 5 mg/mL/min IV on Day 1 of each cycle (Cycles 1 through 4) OR cisplatin 75 mg/m^2 IV on Day 1 of each cycle (Cycles 1 through 4).

If the participant has a complete/partial response or stable disease to induction therapy, the participant can enter the Maintenance Phase and receive pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m^2 IV on Day 1 of each 3-week cycle. The participant can continue to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants can receive pembrolizumab for a total treatment duration of up to ~35 cycles (up to ~2 years [cycle = 3 weeks]).

Group Type: ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type: BIOLOGICAL

IV infusion

Pemetrexed

Intervention Type: DRUG

IV infusion

Carboplatin

Intervention Type: DRUG

IV infusion

Cisplatin

Intervention Type: DRUG

IV infusion

Interventions

Pembrolizumab

IV infusion

Intervention Type: BIOLOGICAL

Pemetrexed

IV infusion

Intervention Type: DRUG

Carboplatin

IV infusion

Intervention Type: DRUG

Cisplatin

IV infusion

Intervention Type: DRUG

Olaparib

Oral Tablet

Intervention Type: DRUG

Other Intervention Names

MK-3475; KEYTRUDA®; ALIMTA®; PARAPLATIN®; PLATINOL®; PLATINOL®-AQ; LYNPARZA®

Eligibility Criteria

Inclusion Criteria

1. Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.

2. Have stage IV nonsquamous NSCLC.

3. Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is not indicated.

4. Have measurable disease based on RECIST 1.1.

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

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

6. Have a life expectancy of at least 3 months.

7. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention.

8. Have not received prior systemic treatment for their advanced/metastatic NSCLC.

9. Have adequate organ function.

10. Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.

11. Male participants must refrain from donating sperm, and female participants must refrain from donating eggs to others or freeze/store for her own use during the treatment period and for 180 days afterwards.

Exclusion Criteria

1. Has predominantly squamous cell histology NSCLC.

2. Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.

3. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

4. Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.

5. Has a known hypersensitivity to any components or excipients of cisplatin, carboplatin, pemetrexed, or olaparib.

6. Has an active autoimmune disease that has required systemic treatment in past 2 years.

7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.

8. Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.

9. Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.

10. Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.

11. Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).

12. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.

13. Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.

14. Has completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Alabama Oncology Bruno Cancer Center ( Site 0001)

Birmingham, Alabama, United States

Northwest Alabama Cancer Center, PC ( Site 0002)

Muscle Shoals, Alabama, United States

Disney Family Cancer Center ( Site 0005)

Burbank, California, United States

Boca Raton Regional Hospital ( Site 0018)

Boca Raton, Florida, United States

Mid-Florida Cancer Centers ( Site 0022)

Orange City, Florida, United States

Moffitt Cancer Center ( Site 0024)

Tampa, Florida, United States

Columbus Regional Research Institute ( Site 0098)

Columbus, Georgia, United States

Mount Sinai Hospital Medical Center ( Site 0032)

Chicago, Illinois, United States

Oncology of Northshore ( Site 0033)

Rolling Meadows, Illinois, United States

Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0036)

Merrillville, Indiana, United States

Medstar Good Samaritan Hospital ( Site 0040)

Baltimore, Maryland, United States

Barbara Ann Karmanos Cancer Institute ( Site 0041)

Detroit, Michigan, United States

Hattiesburg Clinic ( Site 0045)

Hattiesburg, Mississippi, United States

Frontier Oncology ( Site 0080)

Billings, Montana, United States

Bozeman Health Deaconness Cancer Center ( Site 0046)

Bozeman, Montana, United States

Waverly Hematology Oncology ( Site 0081)

Cary, North Carolina, United States

Thompson Cancer Survival Center ( Site 2812)

Knoxville, Tennessee, United States

University of Tennessee Medical Center Knoxville ( Site 0060)

Knoxville, Tennessee, United States

Renovatio Clinical ( Site 0062)

The Woodlands, Texas, United States

Cancer Care Northwest ( Site 0071)

Spokane Valley, Washington, United States

Hospital Italiano Regional del Sur ( Site 0509)

Bahía Blanca, Buenos Aires, Argentina

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

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Britanico de Buenos Aires ( Site 0500)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto Medico Rio Cuarto ( Site 0501)

Río Cuarto, Córdoba Province, Argentina

Centro Oncológico de Rosario ( Site 0507)

Rosario, Santa Fe Province, Argentina

Centro Medico San Roque ( Site 0506)

San Miguel de Tucumán, Tucumán Province, Argentina

Clínica Universitaria Reina Fabiola ( Site 0505)

Córdoba, , Argentina

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

Santa Fe, , Argentina

Liverpool Hospital ( Site 1201)

Liverpool, New South Wales, Australia

Southern Medical Day Care Centre ( Site 1200)

Wollongong, New South Wales, Australia

Townsville General Hospital ( Site 1202)

Townsville, Queensland, Australia

Monash Cancer Centre ( Site 1205)

Clayton, Victoria, Australia

Innsbruck LKH ( Site 1302)

Innsbruck, Tyrol, Austria

Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)

Linz, Upper Austria, Austria

Klinikum Wels-Grieskirchen ( Site 1304)

Wels, Upper Austria, Austria

Social Medical Center - Otto Wagner Hospital ( Site 1301)

Vienna, Vienna, Austria

Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)

Vienna, , Austria

Instituto do Cancer do Ceara ( Site 0201)

Fortaleza, Ceará, Brazil

Hospital Sao Rafael ( Site 0212)

Salvador, Estado de Bahia, Brazil

Oncologica do Brasil ( Site 0210)

Belém, Pará, Brazil

Hospital Tacchini ( Site 0208)

Bento Gonçalves, Rio Grande do Sul, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

Saint Gallen Instituto de Oncologia ( Site 0206)

Santa Cruz do Sul, Rio Grande do Sul, Brazil

YNOVA Pesquisa Clinica ( Site 0215)

Florianópolis, Santa Catarina, Brazil

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

Itajaí, Santa Catarina, Brazil

Centro de Hematologia e Oncologia ( Site 0205)

Joinville, Santa Catarina, Brazil

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

Sao Jose Rio Preto, São Paulo, Brazil

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

Rio de Janeiro, , Brazil

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

São Paulo, , Brazil

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

São Paulo, , Brazil

Hospital Paulistano - Amil Clinical Research ( Site 0207)

São Paulo, , Brazil

Lions Gate Hospital ( Site 0106)

North Vancouver, British Columbia, Canada

BC Cancer - Victoria ( Site 0109)

Victoria, British Columbia, Canada

Queen Elizabeth II Health Sciences Centre ( Site 0107)

Halifax, Nova Scotia, Canada

Health Sciences North Research Institute ( Site 0115)

Greater Sudbury, Ontario, Canada

Waterloo Regional Health Network (WRHN) ( Site 0117)

Kitchener, Ontario, Canada

Stronach Regional Cancer Centre ( Site 0101)

Newmarket, Ontario, Canada

CISSS de la Monteregie-Centre ( Site 0114)

Greenfield Park, Quebec, Canada

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

Montreal, Quebec, Canada

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

Montreal, Quebec, Canada

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

Rimouski, Quebec, Canada

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

Sherbrooke, Quebec, Canada

Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0604)

Medellín, Antioquia, Colombia

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

Barranquilla, Atlántico, Colombia

Administradora Country S.A. ( Site 0603)

Bogotá, Bogota D.C., Colombia

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

Bogotá, Bogota D.C., Colombia

Institut De Cancerologie De Lorraine ( Site 1409)

Vandœuvre-lès-Nancy, Ain, France

Centre Hospitalier De Chauny ( Site 1411)

Chauny, Aisne, France

CHU Caen ( Site 1406)

Caen, Calvados, France

CHU Angers ( Site 1405)

Angers, Maine-et-Loire, France

Hopital Robert Schuman ( Site 1402)

Vantoux, Moselle, France

Centre Jean Perrin ( Site 1407)

Clermont-Ferrand, Puy-de-Dome, France

Centre Hospitalier de Pau ( Site 1412)

Pau, Pyrenees-Atlantiques, France

CHU de Rouen ( Site 1403)

Rouen, Seine-Maritime, France

Hopital d'Instruction des Armees Begin ( Site 1413)

Saint-Mandé, Val-de-Marne, France

Studienzentrum Aschaffenburg ( Site 1525)

Aschaffenburg, Bavaria, Germany

Klinikum der LMU ( Site 1500)

Munich, Bavaria, Germany

Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1523)

Munich, Bavaria, Germany

Universitaetsklinikum Regensburg ( Site 1512)

Regensburg, Bavaria, Germany

Klinikum Wuerzburg Mitte gGmbH ( Site 1509)

Würzburg, Bavaria, Germany

Universitaetsklinikum Frankfurt ( Site 1513)

Frankfurt am Main, Hesse, Germany

Pneumologische Lehrklinik Universitaet Goettingen ( Site 1501)

Immenhausen, Hesse, Germany

Universitaetsmedizin Goettingen ( Site 1507)

Göttingen, Lower Saxony, Germany

Universitaetsklinikum Bonn ( Site 1524)

Bonn, North Rhine-Westphalia, Germany

Kliniken Essen Mitte ( Site 1517)

Essen, North Rhine-Westphalia, Germany

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

Koblenz, Rhineland-Palatinate, Germany

Helios Klinikum Erfurt GmbH ( Site 1502)

Erfurt, Thuringia, Germany

Katholisches Marienkrankenhaus gGmbH ( Site 1522)

Hamburg, , Germany

National Hospital Organization Nagoya Medical Center ( Site 0806)

Nagoya, Aichi-ken, Japan

Aichi Cancer Center ( Site 0803)

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East ( Site 0801)

Kashiwa, Chiba, Japan

Kanazawa University Hospital ( Site 0811)

Kanazawa, Ishikawa-ken, Japan

Kanagawa Cancer Center ( Site 0807)

Yokohama, Kanagawa, Japan

Sendai Kousei Hospital ( Site 0812)

Sendai, Miyagi, Japan

Kansai Medical University Hospital ( Site 0804)

Hirakata, Osaka, Japan

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

Sakai, Osaka, Japan

Shizuoka Cancer Center ( Site 0802)

Suntogun, Shizuoka, Japan

National Hospital Organization Kyushu Medical Center ( Site 0805)

Fukuoka, , Japan

Niigata Cancer Center Hospital ( Site 0808)

Niigata, , Japan

Okayama University Hospital ( Site 0810)

Okayama, , Japan

Osaka International Cancer Institute ( Site 0809)

Osaka, , Japan

Cancer Institute Hospital of JFCR ( Site 0800)

Tokyo, , Japan

MidCentral DHB Palmerston North Hospital ( Site 1102)

Palmerston North, Manawatu-Wanganui, New Zealand

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

Wellington, , New Zealand

Przychodnia Lekarska Komed ( Site 2416)

Konin, Greater Poland Voivodeship, Poland

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

Poznan, Greater Poland Voivodeship, Poland

Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)

Krakow, Lesser Poland Voivodeship, Poland

Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)

Zgorzelec, Lower Silesian Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)

Racibórz, Silesian Voivodeship, Poland

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

Olsztyn, Warmian-Masurian Voivodeship, Poland

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

Bucharest, București, Romania

Cardiomed SRL Cluj-Napoca ( Site 2504)

Cluj-Napoca, Cluj, Romania

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

Cluj-Napoca, Cluj, Romania

Ovidius Clinical Hospital OCH ( Site 2501)

Ovidiu, Constanța County, Romania

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

Craiova, Dolj, Romania

Policlinica Oncomed SRL ( Site 2505)

Timișoara, Timiș County, Romania

Spitalul PDR Medlife ( Site 2509)

Brasov, , Romania

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

Moscow, Moscow, Russia

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

Moscow, Moscow, Russia

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

Moscow, Moscow, Russia

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

Moscow, Moscow, Russia

Moscow Regional Oncological Dispensary ( Site 2028)

Balashikha, Moscow Oblast, Russia

Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)

Nizhny Novgorod, Nizhny Novgorod Oblast, Russia

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

Omsk, Omsk Oblast, Russia

SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)

Samara, Samara Oblast, Russia

SBHI Leningrad Regional Clinical Hospital ( Site 2002)

Saint Petersburg, Sankt-Peterburg, Russia

SPb Central Clinical Railway Hospital ( Site 2003)

Saint Petersburg, Sankt-Peterburg, Russia

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

Saint Petersburg, Sankt-Peterburg, Russia

SPb SBHI City Clinical Oncological Dispensary ( Site 2001)

Saint Petersburg, Sankt-Peterburg, Russia

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

Kazan', Tatarstan, Respublika, Russia

National Cancer Center ( Site 1006)

Goyang-si, Kyonggi-do, South Korea

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

Suwon, Kyonggi-do, South Korea

Ajou University Hospital ( Site 1004)

Suwon, Kyonggi-do, South Korea

Gyeongsang National University Hospital ( Site 1005)

Jinju, Kyongsangnam-do, South Korea

Chungbuk National University Hospital ( Site 1002)

Cheongju-si, North Chungcheong, South Korea

Asan Medical Center ( Site 1007)

Songpa-gu, Seoul, South Korea

Seoul National University Hospital ( Site 1000)

Seoul, , South Korea

Korea University Guro Hospital ( Site 1008)

Seoul, , South Korea

Hospital Universitario Quiron Madrid ( Site 1701)

Pozuelo de Alarcón, Madrid, Spain

Hospital Clinico Universitario de Valencia ( Site 1706)

Valencia, Valenciana, Comunitat, Spain

Hospital del Mar ( Site 1702)

Barcelona, , Spain

Hospital Universitario Nuestra Senora de Valme ( Site 1703)

Seville, , Spain

Hospital Clinico Lozano Blesa ( Site 1700)

Zaragoza, , Spain

Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)

Kaohsiung City, , Taiwan

China Medical University Hospital ( Site 0904)

Taichung, , Taiwan

National Cheng Kung University Hospital ( Site 0905)

Tainan City, , Taiwan

National Taiwan University Hospital ( Site 0900)

Taipei, , Taiwan

Mackay Memorial Hospital ( Site 0902)

Taipei, , Taiwan

Chang Gung Medical Foundation.Linkou Branch ( Site 0903)

Taoyuan District, , Taiwan

Namik Kemal Universitesi Tip Fakultesi ( Site 2100)

Tekirdağ, Tekirdas, Turkey (Türkiye)

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

Adana, , Turkey (Türkiye)

Gazi Universitesi Tip Fakultesi ( Site 2104)

Ankara, , Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi ( Site 2105)

Ankara, , Turkey (Türkiye)

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

Istanbul, , Turkey (Türkiye)

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

Istanbul, , Turkey (Türkiye)

Ege Universitesi Tip Fakultesi ( Site 2109)

Izmir, , Turkey (Türkiye)

Erciyes Universitesi Tip Fakultesi ( Site 2108)

Kayseri, , Turkey (Türkiye)

Ondokuz Mayıs Universitesi-Oncology department ( Site 2106)

Samsun, , Turkey (Türkiye)

Cherkasy Regional Oncology Dispensary ( Site 2211)

Cherkasy, Cherkasy Oblast, Ukraine

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

Dnipro, Dnipropetrovsk Oblast, Ukraine

MI Precarpathian Clinical Oncology Center ( Site 2204)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

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

Kharkiv, Kharkivs’ka Oblast’, Ukraine

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

Kharkiv, Kharkivs’ka Oblast’, Ukraine

PP PPC Acinus Medical and Diagnostic Centre ( Site 2209)

Kropyvnitskiy, Kirovohrad Oblast, Ukraine

Medical Center Asklepion LLC ( Site 2234)

Khodosovka, Kyivska Oblast, Ukraine

Medical Center Verum ( Site 2230)

Kyiv, Kyivska Oblast, Ukraine

Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2213)

Kyiv, Kyivska Oblast, Ukraine

MI Odessa Regional Oncological Centre ( Site 2208)

Odesa, Odesa Oblast, Ukraine

Central City Clinical Hospital ( Site 2207)

Uzhhorod, Zakarpattia Oblast, Ukraine

Kyiv City Clinical Oncology Centre ( Site 2210)

Kyiv, , Ukraine

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

London, London, City of, United Kingdom

Chelsea and Westminster Hospital ( Site 1901)

London, London, City of, United Kingdom

West Suffolk Hospitals NHS Trust ( Site 1919)

Bury St Edmunds, Suffolk, United Kingdom

Western General Hospital, Edinburgh ( Site 1924)

Edinburgh, United Kingdom, United Kingdom

Singleton Hospital ( Site 1909)

Swansea, Wales, United Kingdom

Colchester General Hospital ( Site 1911)

Colchester, Worcestershire, United Kingdom

Birmingham Heartlands Hospital ( Site 1910)

Birmingham, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Brazil; Canada; Colombia; France; Germany; Japan; New Zealand; Poland; Romania; Russia; South Korea; Spain; Taiwan; Turkey (Türkiye); Ukraine; United Kingdom

References

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.

Reference Type: RESULT

PMID: 39521434 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

https://msd.trialsummaries.com/Study/StudyDetails?id=26268&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

MK-7339-006

Identifier Type: OTHER

Identifier Source: secondary_id

KEYLYNK-006

Identifier Type: OTHER

Identifier Source: secondary_id

194895

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-509774-40-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1300-7107

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-004720-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

7339-006

Identifier Type: -

Identifier Source: org_study_id