Clinical trial NCT04380636: Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)
Official title: A Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Keywords: Programmed Cell Death Receptor 1 (PD-1, PD1)
Programmed Cell Death Receptor Ligand 1 (PD-L1, PDL1)
Programmed Cell Death Receptor Ligand 2 (PD-L2, PDL2)
polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2020-05-08
Enrollment: 870
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 purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are:

1. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS)
2. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS


Eligibility criteria: Inclusion Criteria:

* Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC
* Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
* Is unable to undergo surgery with curative intent for Stage III NSCLC
* Has no evidence of metastatic disease indicating Stage IV NSCLC
* Has measurable disease as defined by RECIST 1.1
* Has not received prior treatment (chemotherapy, targeted therapy or radiotherapy) for Stage III NSCLC; participants who have received neoadjuvant and/or adjuvant therapy for early stage disease are not eligible
* Has provided a tumor tissue sample (tissue biopsy \[core, incisional, or excisional\])
* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention
* Has a life expectancy of at least 6 months
* A male participant must agree to use contraception and refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention unless confirmed to be azoospermic (vasectomized or secondary to medical cause). The length of time required to continue contraception for each study intervention is as follows: Olaparib, platinum doublet, and radiotherapy: 90 days
* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use contraception and refrain from donating eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during the treatment period and for at least the time needed to eliminate each study intervention after the last dose of study intervention and agrees to abstain from breastfeeding during the study intervention period and for at least 120 days after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows: Pembrolizumab: 120 days; Olaparib, platinum doublet, and radiotherapy: 180 days
* Has a negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within 24 hours for urine or within 72 hours for serum before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
* Has had her medical history, menstrual history, and recent sexual activity reviewed by the investigator to decrease the risk for inclusion of a woman with an early undetected pregnancy.
* Has adequate pulmonary function tests
* Has adequate organ function
* Has provided written informed consent

Exclusion Criteria:

* Has small cell lung cancer or a mixed tumor with presence of small cell elements
* Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
* Has had documented weight loss \>10% (from baseline) in the preceding 3 months
* Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
* Has received prior therapy with an anti-programmed cell death 1 (ant-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
* Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor
* Has had major surgery \<4 weeks prior to the first dose of study treatment (except for placement of vascular access)
* Is expected to require any other form of antineoplastic therapy, while on study
* Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines is allowed
* Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor \[GCSF\], granulocyte-macrophage colony-stimulating factor \[GM-CSF\] or recombinant erythropoietin) within 28 days prior to the first dose of study treatment
* Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study
* Is currently receiving either strong (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
* Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days before, during, and for at least 2 days after administration of pemetrexed
* Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone during administration of pemetrexed
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study treatment
* The presence of uncontrolled, potentially reversible cardiac conditions, as judged by the investigator or has congenital long QT syndrome
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
* Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (excluding carcinoma-in situ-of the bladder) that have undergone potentially curative therapy
* Has severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of Hepatitis B or known active Hepatitis C virus infection
* Has active tuberculosis (TB; Mycobacterium tuberculosis) and is receiving treatment
* Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
* Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease in the opinion of the treating investigator
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
* Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption
* Has had an allogenic tissue/solid organ transplant

Primary outcomes:
measure: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 48 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 72 months
Secondary outcomes:
measure: Incidence of Adverse Events (AE)
timeFrame: Up to approximately 72 months
measure: Discontinuation Rate of Study Intervention Due to an Adverse Event (AE)
timeFrame: Up to approximately 72 months
measure: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 72 months
measure: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 72 months
measure: Change from Baseline in EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score
timeFrame: Baseline (at randomization) and at the end of study (approximately 72 months post randomization)
measure: Change From Baseline in Cough Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) Item 1 Score
timeFrame: Baseline (at randomization) and at the end of study (approximately 72 months post randomization)
measure: Change From Baseline in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score
timeFrame: Baseline (at randomization) and at the end of study (approximately 72 months post randomization)
measure: Change From Baseline in Dyspnea Using the EORTC QLQ-C30 Item 8 Score
timeFrame: Baseline (at randomization) and at the end of study (approximately 72 months post randomization)
measure: Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score
timeFrame: Baseline (at randomization) and at the end of study (approximately 72 months post randomization)
measure: Change from Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score
timeFrame: Baseline (at randomization) and at the end of study (approximately 72 months post randomization)
measure: Time to Deterioration (TTD) in HRQoL Using the EORTC QLQ-C30 Items 29 and 30 Score
timeFrame: Up to approximately 72 months post randomization
measure: TTD in Cough Using the EORTC QLQ-LC13 Item 1 Score
timeFrame: Up to approximately 72 months post randomization
measure: TTD in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score
timeFrame: Up to approximately 72 months post randomization
measure: TTD in Dyspnea Using the EORTC QLQ-C30 Item 8 Score
timeFrame: Up to approximately 72 months post randomization
measure: TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score
timeFrame: Up to approximately 72 months post randomization
measure: TTD in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score
timeFrame: Up to approximately 72 months post randomization
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama, Mitchell Cancer Institute ( Site 0003)
state: Alabama
city: Jonesboro
country: United States
facility: St. Bernards Medical Center ( Site 0089)
state: Arkansas
city: Fullerton
country: United States
facility: St Joseph Heritage Healthcare-Oncology ( Site 0088)
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center ( Site 0006)
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Santa Monica ( Site 0013)
state: California
city: Santa Rosa
country: United States
facility: St. Joseph Heritage Healthcare Local Lab ( Site 0011)
state: California
city: Torrance
country: United States
facility: Torrance Memorial Physician Network / Cancer Center ( Site 0093)
state: California
city: Hollywood
country: United States
facility: Memorial Regional Hospital-Memorial Cancer Institute ( Site 0095)
state: Florida
city: Miami
country: United States
facility: Miami VA Healthcare System ( Site 0024)
state: Florida
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Center ( Site 0022)
state: Florida
city: Orlando
country: United States
facility: Orlando Health, UF Health Cancer Center Inc ( Site 0092)
state: Florida
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology ( Site 0094)
state: Indiana
city: Fort Wayne
country: United States
facility: Parkview Research Center ( Site 0032)
state: Indiana
city: Lafayette
country: United States
facility: Franciscan Health Lafayette East ( Site 0031)
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky ( Site 0096)
state: Kentucky
city: Louisville
country: United States
facility: Norton Brownsboro Hospital-Norton Cancer Institute - Brownsboro ( Site 0035)
state: Kentucky
city: Pikeville
country: United States
facility: Pikeville Medical Center ( Site 0036)
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital ( Site 0038)
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital ( Site 0045)
state: Michigan
city: Saint Louis
country: United States
facility: VA St. Louis Health Care System ( Site 0047)
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Siteman Cancer Center ( Site 0046)
state: Missouri
city: Grand Island
country: United States
facility: CHI Health St. Francis ( Site 0053)
state: Nebraska
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey ( Site 0054)
state: New Jersey
city: Paramus
country: United States
facility: The Valley Hospital ( Site 0056)
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Einstein Center ( Site 0083)
state: New York
city: Charlotte
country: United States
facility: Novant Health Presbyterian ( Site 0081)
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center ( Site 0050)
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Hematology-Oncology Associates ( Site 0080)
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Center for Research and Education at The Christ Hospital ( Site 0060)
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center ( Site 0063)
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Cancer Center Oncology Clinic ( Site 0066)
state: South Dakota
city: Seattle
country: United States
facility: Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0075)
state: Washington
city: Spokane Valley
country: United States
facility: Cancer Care Northwest ( Site 0074)
state: Washington
city: Río Cuarto
country: Argentina
facility: Instituto Médico Río Cuarto ( Site 4003)
state: Cordoba
city: Caba
country: Argentina
facility: Clinica Adventista Belgrano-Oncology ( Site 4002)
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre ( Site 0100)
state: Nova Scotia
city: Montreal
country: Canada
facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0102)
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0108)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Center - Research Institute ( Site 0114)
state: Quebec
city: Quebec
country: Canada
facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
city: Temuco
country: Chile
facility: Centro Investigación del Cáncer James Lind ( Site 0202)
state: Araucania
city: Santiago
country: Chile
facility: OrlandiOncologia ( Site 0201)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill ( Site 0200)
state: Region M. De Santiago
city: Vina del Mar
country: Chile
facility: Oncocentro ( Site 0203)
state: Valparaiso
city: Antofagasta
country: Chile
facility: Bradford Hill Norte ( Site 0204)
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 3224)
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital ( Site 3201)
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 3213)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 3212)
state: Beijing
city: Chongqing
country: China
facility: Daping Hospital,Third Military Medical University ( Site 3235)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 3226)
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University ( Site 3219)
state: Fujian
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital ( Site 3216)
state: Guangdong
city: Shenzhen
country: China
facility: Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3200)
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 3205)
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital ( Site 3222)
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital ( Site 3218)
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 3238)
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University ( Site 3637)
state: Hunan
city: Changsha
country: China
facility: Second Xiangya Hospital of Central-South University ( Site 3227)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 3225)
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital ( Site 3234)
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University ( Site 3206)
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital ( Site 3230)
state: Jilin
city: Shangai
country: China
facility: Shanghai Chest Hospital ( Site 3207)
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University ( Site 3220)
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital ( Site 3203)
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University ( Site 3202)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital ( Site 3204)
state: Tianjin
city: Hangzhou
country: China
facility: The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3232)
state: Zhejiang
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav ( Site 2206)
state: Brno-mesto
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava ( Site 2201)
state: Ostrava Mesto
city: PRague
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady-Radioterapeuticka a onkologicka klinika ( Site 2200)
state: Praha 10
city: Praha
country: Czechia
facility: Fakultni nemocnice v Motole ( Site 2210)
state: Praha, Hlavni Mesto
city: Nova Ves pod Plesi
country: Czechia
facility: Nemocnice Na Plesi s.r.o. ( Site 2202)
state: Pribram
city: Liberec
country: Czechia
facility: Krajska nemocnice Liberec, a.s. ( Site 2209)
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze ( Site 2208)
city: Praha 8
country: Czechia
facility: Nemocnice Na Bulovce ( Site 2205)
city: Tallin
country: Estonia
facility: North Estonia Medical Centre Foundation ( Site 1601)
state: Harjumaa
city: Tartu
country: Estonia
facility: Tartu University Hospital ( Site 1600)
state: Tartumaa
city: Marseille
country: France
facility: Clinique Clairval ( Site 0802)
state: Bouches-du-Rhone
city: Brest
country: France
facility: C.H.R.U. de Brest - Hopital Morvan ( Site 0806)
state: Bretagne
city: Epagny Metz Tessy
country: France
facility: Centre Hospitalier Annecy Genevois ( Site 0811)
state: Haute-Savoie
city: Valenciennes
country: France
facility: Clinique Teissier Groupe ( Site 0808)
state: Nord
city: Bobigny
country: France
facility: Hopital Avicenne ( Site 0803)
state: Seine-Saint-Denis
city: Amiens
country: France
facility: Clinique de l'Europe-Service de pneumologie ( Site 0816)
state: Somme
city: Toulon
country: France
facility: H.I.A. Sainte-Anne ( Site 0815)
state: Var
city: La Roche sur Yon
country: France
facility: CHD Vendee ( Site 0807)
state: Vendee
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen - Georg-August-Universität ( Site 0917)
state: Niedersachsen
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden ( Site 0908)
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: GEHO Muenster ( Site 0910)
state: Nordrhein-Westfalen
city: Neuss
country: Germany
facility: Johanna Etienne Hospital-Klinik für Onkologie ( Site 0916)
state: Nordrhein-Westfalen
city: Grosshansdorf
country: Germany
facility: LungenClinic Grosshansdorf GmbH ( Site 0901)
state: Schleswig-Holstein
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH ( Site 0905)
state: Thuringen
city: Jena
country: Germany
facility: Universitaetsklinikum Jena ( Site 0911)
state: Thuringen
city: Berlin
country: Germany
facility: Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 0900)
city: Hamburg
country: Germany
facility: Katholisches Marienkrankenhaus gGmbH ( Site 0902)
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2302)
state: Bacs-Kiskun
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2303)
state: Bekes
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz ( Site 2306)
state: Gyor-Moson-Sopron
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 2305)
city: Budapest
country: Hungary
facility: Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2309)
city: Torrette
country: Italy
facility: Azienda Ospedaliera Umberto I- Torrette ( Site 1009)
state: Ancona
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi ( Site 1001)
state: Firenze
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas Research Hospital ( Site 1000)
state: Lombardia
city: Lecce
country: Italy
facility: Azienda Ospedaliera Vito Fazzi ( Site 1003)
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1008)
city: Modena
country: Italy
facility: Policlinico di Modena ( Site 1007)
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli ( Site 1002)
city: Udine
country: Italy
facility: A.O.U. Santa Maria della Misericordia di Udine ( Site 1004)
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 3112)
state: Fukuoka
city: Kobe
country: Japan
facility: Kobe Minimally Invasive Cancer Center ( Site 3100)
state: Hyogo
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 3101)
state: Kanagawa
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 3103)
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital ( Site 3110)
state: Osaka
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 3104)
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 3109)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 3106)
city: Tokyo
country: Japan
facility: Juntendo University Hospital ( Site 3111)
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Komagome Hospital ( Site 3108)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 3107)
city: Tokyo
country: Japan
facility: Showa University Hospital ( Site 3105)
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital ( Site 2802)
state: Chungbuk
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 2800)
state: Kyonggi-do
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent s Hospital ( Site 2805)
state: Kyonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 2801)
state: Kyonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital ( Site 2803)
state: Kyonggi-do
city: Jinju-si
country: Korea, Republic of
facility: Gyeongsang National University Hospital ( Site 2804)
state: Kyongsangnam-do
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital ( Site 2807)
state: Taegu-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital ( Site 2806)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 2808)
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital ( Site 1501)
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital ( Site 1500)
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 4201)
state: Kauno Apskritis
city: Vilnius
country: Lithuania
facility: National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 4200)
state: Vilniaus Miestas
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0500)
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0508)
state: Nuevo Leon
city: Orizaba
country: Mexico
facility: CLIMERS Clinical Medical Research ( Site 0506)
state: Veracruz
city: Tlalpan
country: Mexico
facility: Instituto Nacional de Cancerologia ( Site 0502)
city: Lorenskog
country: Norway
facility: Akershus Universitetssykehus HF ( Site 1106)
state: Akershus
city: Drammen
country: Norway
facility: Vestre Viken HF Drammen Sykehus ( Site 1101)
state: Buskerud
city: Gralum
country: Norway
facility: Sykehuset Oestfold ( Site 1107)
state: Ostfold
city: Stavanger
country: Norway
facility: Helse Stavanger HF Stavanger Universitetssjukehus ( Site 1103)
state: Rogaland
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF. Ulleval ( Site 1100)
city: Arequipa
country: Peru
facility: Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0604)
state: Ariqipa
city: Lima
country: Peru
facility: Oncosalud ( Site 0605)
state: Muni Metro De Lima
city: Surquillo
country: Peru
facility: Detecta Clínica ( Site 0607)
state: Muni Metro De Lima
city: Lima
country: Peru
facility: IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0606)
city: Lima
country: Peru
facility: Clinica San Gabriel ( Site 0601)
city: Lima
country: Peru
facility: Hospital Nacional Cayetano Heredia ( Site 0602)
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2404)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
state: Mazowieckie
city: Gdynia
country: Poland
facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2400)
state: Pomorskie
city: Olsztyn
country: Poland
facility: SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2401)
state: Warminsko-mazurskie
city: Bucharest
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti ( Site 2508)
state: Bucuresti
city: București
country: Romania
facility: Gral Medical SRL-Medical Oncology ( Site 2511)
state: Bucuresti
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2506)
state: Cluj
city: Comuna Floresti
country: Romania
facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 2503)
state: Cluj
city: Craiova
country: Romania
facility: Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2510)
state: Dolj
city: Otopeni
country: Romania
facility: Radiology Therapeutic Center-Oncology ( Site 2502)
state: Ilfov
city: Timisoara
country: Romania
facility: Policlinica Oncomed SRL ( Site 2504)
state: Timis
city: Timișoara
country: Romania
facility: S C Oncocenter Oncologie Clinica S R L-Medical Oncology ( Site 2509)
state: Timis
city: Bucuresti
country: Romania
facility: S.C.Focus Lab Plus S.R.L ( Site 2500)
city: Constanta
country: Romania
facility: Spitalul Clinic Judetean De Urgenta Constanta ( Site 2501)
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi ( Site 2505)
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1913)
state: Chelyabinskaya Oblast
city: Moscow
country: Russian Federation
facility: MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1903)
state: Moskva
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 1914)
state: Nizhegorodskaya Oblast
city: Saint-Petersburg
country: Russian Federation
facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1905)
state: Sankt-Peterburg
city: St. Petersburg
country: Russian Federation
facility: Medical institute named after Berezin Sergey ( Site 1906)
state: Sankt-Peterburg
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Oncology Hospital ( Site 1909)
state: Sverdlovskaya Oblast
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1911)
state: Tatarstan, Respublika
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1910)
state: Yaroslavskaya Oblast
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1202)
state: Madrid
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quiron Madrid ( Site 1200)
state: Madrid
city: Málaga
country: Spain
facility: H.R.U Málaga - Hospital General ( Site 1206)
state: Malaga
city: Barcelona
country: Spain
facility: H.U. Vall de Hebron ( Site 1201)
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona ( Site 1204)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena ( Site 1205)
city: Valencia
country: Spain
facility: Hospital Universitario La Fe ( Site 1203)
city: Bangkok
country: Thailand
facility: Chulalongkorn University ( Site 3003)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital. ( Site 3000)
state: Krung Thep Maha Nakhon
city: Chiang Mai
country: Thailand
facility: Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 3001)
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital. Khon Kaen University ( Site 3002)
city: Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi ( Site 2002)
state: Adana
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi ( Site 2006)
city: Istanbul
country: Turkey
facility: Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2000)
city: Istanbul
country: Turkey
facility: Medipol Universite Hastanesi ( Site 2003)
city: Istanbul
country: Turkey
facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2001)
city: Izmir
country: Turkey
facility: Ege University Medical Faculty ( Site 2005)
city: Dnipro
country: Ukraine
facility: Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107)
state: Dnipropetrovska Oblast
city: Kharkiv
country: Ukraine
facility: SOGrigoriev Inst for Med Radiolgy and Oncology of NAMS of Ukraine-Clinical oncology and hematology (
state: Kharkivska Oblast
city: Antonivka Village
country: Ukraine
facility: Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (
state: Khersonska Oblast
city: Kropyvnytskyi
country: Ukraine
facility: LLC Ukrainian Center of Tomotherapy ( Site 2105)
state: Kirovohradska Oblast
city: Kapitanivka Village
country: Ukraine
facility: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: SNPE National Cancer Institute ( Site 2101)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Medical Center Verum ( Site 2106)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Center ( Site 2100)
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital ( Site 1406)
state: Derbyshire
city: London-Camden
country: United Kingdom
facility: University College Hospital NHS Foundation Trust ( Site 1403)
state: London, City Of
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust ( Site 1410)
state: London, City Of
city: London
country: United Kingdom
facility: Royal Marsden Hospital (Sutton) ( Site 1407)
state: Surrey
city: Southampton
country: United Kingdom
facility: Southampton General Hospital ( Site 1400)
state: Worcestershire
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust ( Site 1401)
city: Manchester
country: United Kingdom
facility: Christie NHS Foundation Trust ( Site 1409)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Jabbour SK, Cho BC, Bria E, Kato T, Bhosle J, Gainor JF, Reguart N, Wang L, Morgensztern D, Shentu Y, Kim SJ, Souza F, Reck M. Rationale and Design of the Phase III KEYLYNK-012 Study of Pembrolizumab and Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Stage III Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2022 Sep;23(6):e342-e346. doi: 10.1016/j.cllc.2022.04.003. Epub 2022 Apr 29.