Clinical trial NCT04624204: Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)
Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants With Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Small Cell Lung Cancer
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Pembrolizumab
Olaparib
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2020-11-10
Enrollment: 672
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: Researchers are looking for new ways to treat Limited-Stage Small Cell Lung Cancer (LS-SCLC), a type of lung cancer that has not spread from the lung to other parts of the body. The purpose of this study is to learn if pembrolizumab and olaparib, when given with chemotherapy and radiation treatment (CRT), can be effective in treating LS-SCLC. The researchers want to know if participants who receive CRT and pembrolizumab, with or without olaparib, have a longer overall survival compared to participants who only receive CRT.


Eligibility criteria: Inclusion Criteria:

1. Has pathologically (histologically or cytologically) confirmed Small Cell Lung Cancer (SCLC).

   Note: Note: Participants with histology showing a mixed tumor with small cell and non-small cell elements are not eligible.
2. Has Limited-Stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses.
3. Has no evidence of metastatic disease by whole body positron emission tomography /computed tomography (PET/CT scan), CT or magnetic resonance imaging (MRI) scans
4. Has at least 1 lesion that meets the criteria for being measurable, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
5. Has not received prior treatment (chemotherapy or radiotherapy or surgery resection) of LS-SCLC.
6. Is not expected to require tumor resection during the course of the study.
7. Must submit a pre-treatment tumor tissue sample (formalin-fixed, paraffin embedded blocks are preferred to slides) including cytologic sample, if tissue sample unavailable.
8. Has Eastern Cooperative Oncology Group (ECOG) Performance score 0 or 1 assessed within 7 days prior to the first administration of study intervention.
9. Has a life expectancy of at least 6 months.
10. Has adequate organ function.
11. Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention.
12. Male and female participants who are at least 18 years of age at the time of signing the information consent.
13. Male participants must refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention.
14. Abstains from breastfeeding during the study intervention period and for at least the following period after the last study intervention:

    * Pembrolizumab: 120 days
    * Olaparib: 7 days

Exclusion Criteria:

1. Has history, current diagnosis, or features suggestive of myelodysplastic syndrome/ acute myeloid leukemia (MDS/AML).
2. Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PDL1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
3. Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
4. Had major surgery \<4 weeks prior to the first dose of study intervention (except for placement of vascular access).
5. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
8. Has severe hypersensitivity (≥ Grade 3) to study intervention and/or any of its excipients.
9. Has an active autoimmune disease that has required systemic treatment in past 2 years
10. Has a history of (non-infectious) pneumonitis/interstitial lung disease that requires steroids
11. Has an active infection requiring systemic therapy.
12. Has a known history of human immunodeficiency virus (HIV) infection or Hepatitis B or known active Hepatitis C virus infection.

Primary outcomes:
measure: Progression-free Survival Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); the time from randomization to progression or death due to any cause, whichever occurs first
timeFrame: Up to approximately 59 months
measure: Overall Survival: the time from randomization to death due to any cause
timeFrame: Up to approximately 82 months
Secondary outcomes:
measure: Number of Participants Experiencing an Adverse Events (AEs)
timeFrame: Up to approximately 82 months
measure: Number of Participants Discontinuing Study Treatment Due to Adverse Events (AEs)
timeFrame: Up to approximately 82 months
measure: Objective Response (OR): Complete Response (CR) or Partial Response (PR)
timeFrame: Up to approximately 82 months
measure: Duration of Response (DOR): the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first
timeFrame: Up to approximately 82 months
measure: Change from Baseline at Cycle 1 in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 & 30) Scale Score
timeFrame: Baseline and 82 months post randomization
measure: Change from Baseline at Cycle 1 in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
timeFrame: Baseline and 82 months post randomization
measure: Change from Baseline at Cycle 1 in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score
timeFrame: Baseline and 82 months post randomization
measure: Change from Baseline at Cycle 1 in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
timeFrame: Baseline and 82 months post randomization
measure: Change from Baseline at Cycle 1 in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
timeFrame: Baseline and 82 months post randomization
measure: Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score
timeFrame: Up to approximately 82 months post randomization
measure: Time to True Deterioration (TTD) in Cough (LC13/Item 1) Scale Score
timeFrame: Up to approximately 82 months post randomization
measure: Time to True Deterioration (TTD) in Chest Pain (LC13/Item 10) Scale Score
timeFrame: Up to approximately 82 months post randomization
measure: Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
timeFrame: Up to approximately 82 months post randomization
measure: Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
timeFrame: Up to approximately 82 months post randomization
measure: Objective Response (OR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels
timeFrame: Up to approximately 82 months
measure: Duration of Response (DOR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels
timeFrame: Up to approximately 82 months
measure: Progression-free Survival (PFS, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels
timeFrame: Up to approximately 59 months
measure: Overall Survival (OS) assessed by programmed cell death ligand 1 (PD-L1) expression levels
timeFrame: Up to approximately 82 months
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers ( Site 0007)
state: Arizona
city: Loma Linda
country: United States
facility: Loma Linda University Cancer Center ( Site 0011)
state: California
city: Washington
country: United States
facility: Georgetown University ( Site 0017)
state: District of Columbia
city: Tampa
country: United States
facility: Moffitt Cancer Center ( Site 0137)
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center ( Site 0136)
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology ( Site 0034)
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center ( Site 0138)
state: Kentucky
city: Shreveport
country: United States
facility: Overton Brooks VAMC ( Site 0041)
state: Louisiana
city: Baltimore
country: United States
facility: Harry & Jeanette Weinberg Cancer Institute ( Site 0045)
state: Maryland
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System ( Site 0050)
state: Michigan
city: Billings
country: United States
facility: St. Vincent Healthcare Frontier Cancer Center ( Site 0056)
state: Montana
city: Omaha
country: United States
facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061)
state: Nebraska
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering - Basking Ridge ( Site 0133)
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Cancer Center ( Site 0064)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering - Monmouth ( Site 0135)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering - Bergen ( Site 0130)
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey ( Site 0123)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering- Commack ( Site 0132)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering - Westchester-Thoracic Oncology ( Site 0134)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center ( Site 0069)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering - Nassau ( Site 0131)
state: New York
city: Cleveland
country: United States
facility: Fairview Hospital-Moll Cancer Center ( Site 0141)
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Main ( Site 0139)
state: Ohio
city: Mayfield Heights
country: United States
facility: Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0140)
state: Ohio
city: Hershey
country: United States
facility: Penn State Hershey Cancer Institute ( Site 0081)
state: Pennsylvania
city: Greenville
country: United States
facility: Saint Francis Cancer Center ( Site 0087)
state: South Carolina
city: Knoxville
country: United States
facility: The University of Tennessee Medical Center ( Site 0116)
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology - Dallas (Presbyterian)_McIntyre ( Site 0098)
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Dallas (Sammons) ( Site 0093)
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center ( Site 0100)
state: Texas
city: Houston
country: United States
facility: Millennium Research & Clinical Development ( Site 0143)
state: Texas
city: Everett
country: United States
facility: Providence Regional Cancer Partnership ( Site 0106)
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates, PS ( Site 0142)
state: Washington
city: Tacoma
country: United States
facility: Multicare Institute For Research And Innovation ( Site 0108)
state: Washington
city: Yakima
country: United States
facility: Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0112)
state: Washington
city: Campbelltown
country: Australia
facility: Campbelltown Hospital ( Site 3002)
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital ( Site 3001)
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle ( Site 3000)
state: New South Wales
city: Southport
country: Australia
facility: Gold Coast University Hospital ( Site 3003)
state: Queensland
city: Frankston
country: Australia
facility: Frankston Hospital-Oncology and Haematology ( Site 3007)
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health-Austin Hospital ( Site 3006)
state: Victoria
city: St Albans
country: Australia
facility: Western Health-Sunshine Hospital ( Site 3004)
state: Victoria
city: Brussels
country: Belgium
facility: Saint-Luc UCL ( Site 1005)
state: Bruxelles-Capitale, Region De
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi ( Site 1003)
state: Hainaut
city: Mons
country: Belgium
facility: C.I.U. Hopital Ambroise Pare ( Site 1001)
state: Hainaut
city: Yvoir
country: Belgium
facility: CHU UCL Namur Site de Godinne ( Site 1004)
state: Namur
city: Leuven
country: Belgium
facility: UZ Leuven ( Site 1002)
state: Vlaams-Brabant
city: Roeselare
country: Belgium
facility: AZ Delta ( Site 1000)
state: West-Vlaanderen
city: Panagyurishte
country: Bulgaria
facility: MHAT "Uni Hospital" OOD ( Site 2507)
state: Pazardzhik
city: Edmonton
country: Canada
facility: Cross Cancer Institute ( Site 0206)
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0212)
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0202)
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 0210)
state: Quebec
city: Trois-Rivieres
country: Canada
facility: CIUSSS de la Mauricie et du Centre du Quebec ( Site 0200)
state: Quebec
city: Beijing
country: China
facility: Peking Union Medical College Hospital ( Site 3102)
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 3104)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 3127)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 3140)
state: Beijing
city: Chongqing
country: China
facility: Chongqing Cancer Hospital ( Site 3135)
state: Chongqing
city: Chongqing
country: China
facility: Daping Hospital,Third Military Medical University ( Site 3136)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 3126)
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University ( Site 3121)
state: Fujian
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital ( Site 3118)
state: Guangdong
city: Shenzhen
country: China
facility: Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3113)
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 3105)
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital ( Site 3123)
state: Hubei
city: Wuhan
country: China
facility: Tongji Medical College Huazhong University of Science and Technology ( Site 3138)
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital ( Site 3120)
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 3133)
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University ( Site 3137)
state: Hunan
city: Changsha
country: China
facility: Second Xiangya Hospital of Central-South University ( Site 3128)
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital ( Site 3139)
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University ( Site 3106)
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University ( Site 3132)
state: Jilin
city: Jinan
country: China
facility: Shandong Province Cancer Hospital ( Site 3100)
state: Shandong
city: Shangai
country: China
facility: Shanghai Chest Hospital ( Site 3107)
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital ( Site 3101)
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University ( Site 3114)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital ( Site 3103)
state: Tianjin
city: Hanghzou
country: China
facility: Hangzhou Cancer Hospital ( Site 3129)
state: Zhejiang
city: Hangzhou
country: China
facility: The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3131)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital.... ( Site 3108)
state: Zhejiang
city: Tallinn
country: Estonia
facility: SA Pohja-Eesti Regionaalhaigla ( Site 2201)
state: Harjumaa
city: Tartu
country: Estonia
facility: SA Tartu Ulikooli Kliinikum ( Site 2200)
state: Tartumaa
city: Saint Quentin
country: France
facility: C.H. de Saint Quentin ( Site 1111)
state: Aisne
city: Bordeaux
country: France
facility: CHU de Bordeaux Hop St ANDRE ( Site 1115)
state: Aquitaine
city: Marseille
country: France
facility: Clinique Clairval ( Site 1108)
state: Bouches-du-Rhone
city: Paris
country: France
facility: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1105)
state: Ile-de-France
city: Grenoble
country: France
facility: CHU Grenoble -Hop Michallon ( Site 1102)
state: Isere
city: Saint Herblain
country: France
facility: Institut De Cancerologie De L Ouest ( Site 1110)
state: Loire-Atlantique
city: Angers
country: France
facility: Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1103)
state: Maine-et-Loire
city: Bobigny
country: France
facility: Hopital Avicenne ( Site 1106)
state: Seine-Saint-Denis
city: Toulon
country: France
facility: H.I.A. Sainte-Anne ( Site 1101)
state: Var
city: Athens
country: Greece
facility: Henry Dunant Hospital ( Site 1205)
state: Attiki
city: Athens
country: Greece
facility: Sotiria Regional Chest Diseases Hospital of Athens ( Site 1200)
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Herakleion ( Site 1202)
state: Irakleio
city: Thessaloniki
country: Greece
facility: Anti-Cancer Hospital of Thessaloniki Theagenio ( Site 1204)
state: Kentriki Makedonia
city: Larissa
country: Greece
facility: University General Hospital of Larisa ( Site 1201)
state: Thessalia
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1306)
state: Bacs-Kiskun
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz ( Site 1312)
state: Gyor-Moson-Sopron
city: Torokbalint
country: Hungary
facility: Reformatus Pulmonologiai Centrum ( Site 1304)
state: Pest
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 1301)
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet ( Site 1310)
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz ( Site 1303)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology Division ( Site 1401)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center ( Site 1400)
city: Modena
country: Italy
facility: A O U Policlinico di Modena ( Site 1503)
state: Emilia-Romagna
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi ( Site 1509)
state: Firenze
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento-Oncology Unit ( Site 1513
state: Veneto
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia ( Site 1512)
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele ( Site 1500)
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori ( Site 1504)
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia ( Site 1501)
city: Padova
country: Italy
facility: IRCCS Istituto Oncologico Veneto ( Site 1506)
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli ( Site 1505)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 4010)
state: Aichi
city: Kobe
country: Japan
facility: Kobe Minimally Invasive Cancer Center ( Site 4003)
state: Hyogo
city: Takarazuka
country: Japan
facility: Takarazuka City Hospital ( Site 4013)
state: Hyogo
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 4001)
state: Kanagawa
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 4009)
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital ( Site 4007)
state: Osaka
city: Nagaizumi
country: Japan
facility: Shizuoka Cancer Center ( Site 4014)
state: Shizuoka
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 4000)
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 4004)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 4012)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 4005)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 4015)
city: Tokyo
country: Japan
facility: Juntendo University Hospital ( Site 4008)
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Komagome Hospital ( Site 4011)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 4006)
city: Tokyo
country: Japan
facility: Showa University Hospital ( Site 4002)
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 3306)
state: Kyonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 3301)
state: Kyonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent s Hospital ( Site 3303)
state: Kyonggi-do
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital ( Site 3307)
state: Pusan-Kwangyokshi
city: Songpagu
country: Korea, Republic of
facility: Asan Medical Center ( Site 3308)
state: Seoul
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital CRC room 1 ( Site 3302)
state: Taegu-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 3304)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 3300)
city: Vilnius
country: Lithuania
facility: Nacionalinis Vezio Institutas ( Site 2300)
state: Vilniaus Miestas
city: Kaunas
country: Lithuania
facility: LSMUL Kauno Klinikos ( Site 2301)
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0401)
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0404)
state: Nuevo Leon
city: Lisboa
country: Portugal
facility: Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 1705)
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1704)
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 1701)
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2803)
state: Cluj
city: Florești
country: Romania
facility: Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2805)
state: Cluj
city: Ploiesti
country: Romania
facility: Spitalul Municipal Ploiesti ( Site 2801)
state: Prahova
city: Timisoara
country: Romania
facility: Cabinet Medical Oncomed ( Site 2802)
state: Timis
city: Bucuresti
country: Romania
facility: S.C.Focus Lab Plus S.R.L ( Site 2804)
city: Balashikha
country: Russian Federation
facility: Moscow Regional Oncological Dispensary-Oncology (thoracic surgery) Department №1 ( Site 1815)
state: Moskovskaya Oblast
city: Moscow
country: Russian Federation
facility: Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 1812)
state: Moskva
city: Moscow
country: Russian Federation
facility: MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1800)
state: Moskva
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 1811)
state: Nizhegorodskaya Oblast
city: Omsk
country: Russian Federation
facility: Omsk Clinical Oncology Dispensary ( Site 1806)
state: Omskaya Oblast
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Oncology Hospital ( Site 1807)
state: Sverdlovskaya Oblast
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1814)
state: Tatarstan, Respublika
city: Belgrade
country: Serbia
facility: Institute for Oncology and Radiology of Serbia ( Site 2995)
state: Beograd
city: Sremska Kamenica
country: Serbia
facility: Institut za plucne bolesti Vojvodine Sremska Kamenica ( Site 2991)
state: Sremski Okrug
city: Pretoria
country: South Africa
facility: Steve Biko Academic Hospital ( Site 5000)
state: Gauteng
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital ( Site 5002)
state: Western Cape
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias ( Site 1900)
state: Asturias
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals ( Site 1903)
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron ( Site 1904)
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre ( Site 1902)
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga ( Site 1905)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1907)
city: Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi ( Site 2007)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2009)
city: Istanbul
country: Turkey
facility: Medipol Universite Hastanesi ( Site 2005)
city: Istanbul
country: Turkey
facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2003)
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)
city: Dnipro
country: Ukraine
facility: Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107)
state: Dnipropetrovska Oblast
city: Kharkiv
country: Ukraine
facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2110)
state: Kharkivska Oblast
city: Khmelnytskyi
country: Ukraine
facility: Municipal non-profit Enterprise "Khmelnytskyi Regional Antitumor Center" ( Site 2115)
state: Khmelnytska 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: Clinic of National Cancer Institute ( Site 2101)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Medical Center Verum ( Site 2106)
state: Kyivska Oblast
city: Pliuty
country: Ukraine
facility: LISOD. Hospital ( Site 2111)
state: Kyiv
city: Vinnytsia
country: Ukraine
facility: Communal Noncommercial Enterprise "Podillia Regional Oncolog-Chemotherapy Department ( Site 2114)
state: Vinnytska Oblast
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Center ( Site 2100)
city: Aberdeen
country: United Kingdom
facility: Royal Infirmary Aberdeen ( Site 2403)
state: Aberdeen City
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School ( Site 2401)
state: Dundee City
city: Taunton
country: United Kingdom
facility: Taunton and Somerset Hospital ( Site 2404)
state: England
city: London
country: United Kingdom
facility: Barts Health NHS Trust ( Site 2409)
state: London, City Of
city: London
country: United Kingdom
facility: Guy s & St Thomas NHS Foundation Trust ( Site 2408)
state: London, City Of
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust ( Site 2405)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: Rimner A, Lai WV, Califano R, Jabbour SK, Rudin CM, Faivre-Finn C, Cho BC, Kato T, Yu J, Chafin W, Yu L, Zhao B, Byers L. Rationale and Design of the Phase 3 KEYLYNK-013 Study of Pembrolizumab With Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Limited-Stage Small-Cell Lung Cancer. Clin Lung Cancer. 2022 Jul;23(5):e325-e329. doi: 10.1016/j.cllc.2022.04.005. Epub 2022 Apr 29.