Clinical trial NCT03976323: 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)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
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)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-06-06
Enrollment: 1003
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to ~31 months
measure: Overall Survival (OS)
timeFrame: Up to ~51 months
Secondary outcomes:
measure: Number of Participants Who Experience One or More Adverse Events (AEs)
timeFrame: Up to ~5 years
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to ~5 years
measure: 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
timeFrame: Baseline and Week 24
measure: Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score
timeFrame: Up to ~24 months
measure: Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
timeFrame: Baseline and Week 24
measure: TTD in EORTC QLQ-LC13 Cough (Item 1) Scale Score
timeFrame: Up to ~24 months
measure: Change From Baseline in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score
timeFrame: Baseline and Week 24
measure: TTD in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score
timeFrame: Up to ~24 months
measure: Change From Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
timeFrame: Baseline and Week 24
measure: TTD in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
timeFrame: Up to ~24 months
measure: Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
timeFrame: Baseline and Week 24
measure: TTD in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
timeFrame: Up to ~24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Oncology Bruno Cancer Center ( Site 0001)
state: Alabama
city: Muscle Shoals
country: United States
facility: Northwest Alabama Cancer Center, PC ( Site 0002)
state: Alabama
city: Burbank
country: United States
facility: Disney Family Cancer Center ( Site 0005)
state: California
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital ( Site 0018)
state: Florida
city: Orange City
country: United States
facility: Mid-Florida Cancer Centers ( Site 0022)
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center ( Site 0024)
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute ( Site 0098)
state: Georgia
city: Chicago
country: United States
facility: Mount Sinai Hospital Medical Center ( Site 0032)
state: Illinois
city: Rolling Meadows
country: United States
facility: Oncology of Northshore ( Site 0033)
state: Illinois
city: Merrillville
country: United States
facility: Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0036)
state: Indiana
city: Baltimore
country: United States
facility: Medstar Good Samaritan Hospital ( Site 0040)
state: Maryland
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute ( Site 0041)
state: Michigan
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic ( Site 0045)
state: Mississippi
city: Billings
country: United States
facility: Frontier Oncology ( Site 0080)
state: Montana
city: Bozeman
country: United States
facility: Bozeman Health Deaconness Cancer Center ( Site 0046)
state: Montana
city: Cary
country: United States
facility: Waverly Hematology Oncology ( Site 0081)
state: North Carolina
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center ( Site 2812)
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center Knoxville ( Site 0060)
state: Tennessee
city: The Woodlands
country: United States
facility: Renovatio Clinical ( Site 0062)
state: Texas
city: Spokane Valley
country: United States
facility: Cancer Care Northwest ( Site 0071)
state: Washington
city: Bahia Blanca
country: Argentina
facility: Hospital Italiano Regional del Sur ( Site 0509)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires ( Site 0500)
state: Caba
city: Rio Cuarto
country: Argentina
facility: Instituto Medico Rio Cuarto ( Site 0501)
state: Cordoba
city: Rosario
country: Argentina
facility: Centro Oncológico de Rosario ( Site 0507)
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico San Roque ( Site 0506)
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires ( Site 0511)
city: Cordoba
country: Argentina
facility: Clínica Universitaria Reina Fabiola ( Site 0505)
city: Santa Fe
country: Argentina
facility: Sanatorio Privado San Geronimo S.R.L ( Site 0510)
city: Liverpool
country: Australia
facility: Liverpool Hospital ( Site 1201)
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Centre ( Site 1200)
state: New South Wales
city: Townsville
country: Australia
facility: Townsville General Hospital ( Site 1202)
state: Queensland
city: Clayton
country: Australia
facility: Monash Cancer Centre ( Site 1205)
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)
state: Oberosterreich
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen ( Site 1304)
state: Oberosterreich
city: Innsbruck
country: Austria
facility: Innsbruck LKH ( Site 1302)
state: Tirol
city: Vienna
country: Austria
facility: Social Medical Center - Otto Wagner Hospital ( Site 1301)
state: Wien
city: Wien
country: Austria
facility: Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)
city: Salvador
country: Brazil
facility: Hospital Sao Rafael ( Site 0212)
state: Bahia
city: Fortaleza
country: Brazil
facility: Instituto do Cancer do Ceara ( Site 0201)
state: Ceara
city: Belem
country: Brazil
facility: Oncologica do Brasil ( Site 0210)
state: Para
city: Bento Goncalves
country: Brazil
facility: Hospital Tacchini ( Site 0208)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0209)
state: Rio Grande Do Sul
city: Santa Cruz do Sul
country: Brazil
facility: Saint Gallen Instituto de Oncologia ( Site 0206)
state: Rio Grande Do Sul
city: Florianopolis
country: Brazil
facility: YNOVA Pesquisa Clinica ( Site 0215)
state: Santa Catarina
city: Itajai
country: Brazil
facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0202)
state: Santa Catarina
city: Joinville
country: Brazil
facility: Centro de Hematologia e Oncologia ( Site 0205)
state: Santa Catarina
city: Sao Jose Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0204)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0203)
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0200)
city: Sao Paulo
country: Brazil
facility: Hospital Paulistano - Amil Clinical Research ( Site 0207)
city: Sao Paulo
country: Brazil
facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0214)
city: North Vancouver
country: Canada
facility: Lions Gate Hospital ( Site 0106)
state: British Columbia
city: Victoria
country: Canada
facility: BC Cancer - Victoria ( Site 0109)
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre ( Site 0107)
state: Nova Scotia
city: Kitchener
country: Canada
facility: Grand River Hospital ( Site 0117)
state: Ontario
city: Newmarket
country: Canada
facility: Stronach Regional Cancer Centre ( Site 0101)
state: Ontario
city: Sudbury
country: Canada
facility: Health Sciences North Research Institute ( Site 0115)
state: Ontario
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie-Centre ( Site 0114)
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0105)
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)
state: Quebec
city: Rimouski
country: Canada
facility: Centre de Sante et des Services Sociaux de Rimouski-Neigette ( Site 0104)
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103)
state: Quebec
city: Medellin
country: Colombia
facility: Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0604)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Clinica de la Costa Ltda. ( Site 0608)
state: Atlantico
city: Bogota
country: Colombia
facility: Administradora Country S.A. ( Site 0603)
state: Distrito Capital De Bogota
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0601)
state: Distrito Capital De Bogota
city: Chauny
country: France
facility: Centre Hospitalier De Chauny ( Site 1411)
state: Aisne
city: Caen
country: France
facility: CHU Caen ( Site 1406)
state: Calvados
city: Angers
country: France
facility: CHU Angers ( Site 1405)
state: Maine-et-Loire
city: Vandoeuvre les Nancy
country: France
facility: Institut De Cancerologie De Lorraine ( Site 1409)
state: Meurthe-et-Moselle
city: Vantoux
country: France
facility: Hopital Robert Schuman ( Site 1402)
state: Moselle
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin ( Site 1407)
state: Puy-de-Dome
city: Pau
country: France
facility: Centre Hospitalier de Pau ( Site 1412)
state: Pyrenees-Atlantiques
city: Rouen
country: France
facility: CHU de Rouen ( Site 1403)
state: Seine-Maritime
city: Saint-Mande
country: France
facility: Hopital d'Instruction des Armees Begin ( Site 1413)
state: Val-de-Marne
city: Aschaffenburg
country: Germany
facility: Studienzentrum Aschaffenburg ( Site 1525)
state: Bayern
city: Muenchen
country: Germany
facility: Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1523)
state: Bayern
city: Munich
country: Germany
facility: Klinikum der LMU ( Site 1500)
state: Bayern
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg ( Site 1512)
state: Bayern
city: Wuerzburg
country: Germany
facility: Klinikum Wuerzburg Mitte gGmbH ( Site 1509)
state: Bayern
city: Frankfurt
country: Germany
facility: Universitaetsklinikum Frankfurt ( Site 1513)
state: Hessen
city: Immenhausen
country: Germany
facility: Pneumologische Lehrklinik Universitaet Goettingen ( Site 1501)
state: Hessen
city: Goettingen
country: Germany
facility: Universitaetsmedizin Goettingen ( Site 1507)
state: Niedersachsen
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn ( Site 1524)
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Kliniken Essen Mitte ( Site 1517)
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1514)
state: Rheinland-Pfalz
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt GmbH ( Site 1502)
state: Thuringen
city: Hamburg
country: Germany
facility: Katholisches Marienkrankenhaus gGmbH ( Site 1522)
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center ( Site 0806)
state: Aichi
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 0803)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 0801)
state: Chiba
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 0811)
state: Ishikawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 0807)
state: Kanagawa
city: Sendai
country: Japan
facility: Sendai Kousei Hospital ( Site 0812)
state: Miyagi
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 0804)
state: Osaka
city: Sakai
country: Japan
facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)
state: Osaka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0802)
state: Shizuoka
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center ( Site 0805)
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 0808)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 0810)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 0809)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 0800)
city: Cheongju si
country: Korea, Republic of
facility: Chungbuk National University Hospital ( Site 1002)
state: Chungbuk
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 1006)
state: Kyonggi-do
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent s Hospital ( Site 1003)
state: Kyonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital ( Site 1004)
state: Kyonggi-do
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital ( Site 1005)
state: Kyongsangnam-do
city: Songpa-gu
country: Korea, Republic of
facility: Asan Medical Center ( Site 1007)
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 1000)
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital ( Site 1008)
city: Palmerston North
country: New Zealand
facility: MidCentral DHB Palmerston North Hospital ( Site 1102)
state: Manawatu-Wanganui
city: Wellington
country: New Zealand
facility: Capital & Coast District Health Board - Wellington Hospital ( Site 1101)
city: Zgorzelec
country: Poland
facility: Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)
state: Dolnoslaskie
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)
state: Malopolskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
state: Mazowieckie
city: Raciborz
country: Poland
facility: Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)
state: Slaskie
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 2417)
state: Warminsko-mazurskie
city: Konin
country: Poland
facility: Przychodnia Lekarska Komed ( Site 2416)
state: Wielkopolskie
city: Poznan
country: Poland
facility: MED-POLONIA Sp. z o.o. ( Site 2419)
state: Wielkopolskie
city: Cluj Napoca
country: Romania
facility: Cardiomed SRL Cluj-Napoca ( Site 2504)
state: Cluj
city: Cluj-Napoca
country: Romania
facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 2507)
state: Cluj
city: Craiova
country: Romania
facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2508)
state: Dolj
city: Timisoara
country: Romania
facility: Policlinica Oncomed SRL ( Site 2505)
state: Timis
city: Brasov
country: Romania
facility: Spitalul PDR Medlife ( Site 2509)
city: Bucuresti
country: Romania
facility: S.C.Focus Lab Plus S.R.L ( Site 2502)
city: Constanta
country: Romania
facility: Spitalul Clinic Judetean De Urgenta Constanta ( Site 2501)
city: Saint Petersburg
country: Russian Federation
facility: SBHI Leningrad Regional Clinical Hospital ( Site 2002)
state: Leningradskaya Oblast
city: Balashikha
country: Russian Federation
facility: Moscow Regional Oncological Dispensary ( Site 2028)
state: Moskovskaya Oblast
city: Moscow
country: Russian Federation
facility: Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 2000)
state: Moskva
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024)
state: Moskva
city: Moscow
country: Russian Federation
facility: Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009)
state: Moskva
city: Moscow
country: Russian Federation
facility: FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006)
state: Moskva
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)
state: Nizhegorodskaya Oblast
city: Omsk
country: Russian Federation
facility: Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site
state: Omskaya Oblast
city: Samara
country: Russian Federation
facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)
state: Samarskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: SPb Central Clinical Railway Hospital ( Site 2003)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 2004)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: SPb SBHI City Clinical Oncological Dispensary ( Site 2001)
state: Sankt-Peterburg
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2021)
state: Tatarstan, Respublika
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quiron Madrid ( Site 1701)
state: Madrid
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia ( Site 1706)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Hospital del Mar ( Site 1702)
city: Sevilla
country: Spain
facility: Hospital Universitario Nuestra Senora de Valme ( Site 1703)
city: Zaragoza
country: Spain
facility: Hospital Clinico Lozano Blesa ( Site 1700)
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 0904)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 0905)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0900)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital ( Site 0902)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation.Linkou Branch ( Site 0903)
city: Tekirdag
country: Turkey
facility: Namik Kemal Universitesi Tip Fakultesi ( Site 2100)
state: Tekirdas
city: Adana
country: Turkey
facility: Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 2101)
city: Ankara
country: Turkey
facility: Gazi Universitesi Tip Fakultesi ( Site 2104)
city: Ankara
country: Turkey
facility: Ankara Sehir Hastanesi ( Site 2105)
city: Istanbul
country: Turkey
facility: Bezmialem Vakif Univ. Tıp Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107)
city: Istanbul
country: Turkey
facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2103)
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi ( Site 2109)
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tip Fakultesi ( Site 2108)
city: Samsun
country: Turkey
facility: Samsun Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 2106)
city: Cherkasy
country: Ukraine
facility: Cherkasy Regional Oncology Dispensary ( Site 2211)
state: Cherkaska Oblast
city: Dnipro
country: Ukraine
facility: City Clinical Hosp.4 of DCC ( Site 2201)
state: Dnipropetrovska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: MI Precarpathian Clinical Oncology Center ( Site 2204)
state: Ivano-Frankivska Oblast
city: Kharkiv
country: Ukraine
facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2212)
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: Regional Centre of Oncology-Thoracic organs ( Site 2205)
state: Kharkivska Oblast
city: Kropyvnitskiy
country: Ukraine
facility: PP PPC Acinus Medical and Diagnostic Centre ( Site 2209)
state: Kirovohradska Oblast
city: Khodosivka
country: Ukraine
facility: Medical Center Asklepion LLC ( Site 2234)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2213)
state: Kyivska Oblast
city: Odesa
country: Ukraine
facility: MI Odessa Regional Oncological Centre ( Site 2208)
state: Odeska Oblast
city: Uzhgorod
country: Ukraine
facility: Central City Clinical Hospital ( Site 2207)
state: Zakarpatska Oblast
city: Kyiv
country: Ukraine
facility: Medical Center Verum ( Site 2230)
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Centre ( Site 2210)
city: London
country: United Kingdom
facility: Barts Health NHS Trust - St Bartholomew s Hospital ( Site 1923)
state: London, City Of
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital ( Site 1901)
state: London, City Of
city: Bury Saint Edmunds
country: United Kingdom
facility: West Suffolk Hospitals NHS Trust ( Site 1919)
state: Suffolk
city: Colchester
country: United Kingdom
facility: Colchester General Hospital ( Site 1911)
state: Worcestershire
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital ( Site 1910)
city: Edinburg
country: United Kingdom
facility: Western General Hospital, Edinburgh ( Site 1924)
city: Swansea
country: United Kingdom
facility: Singleton Hospital ( Site 1909)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.