Clinical trial NCT03066778: A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604)
Official title: A Phase 3 Randomized, Double-Blind, Placebo-controlled Trial of Pembrolizumab (MK-3475/SCH900475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for the First-line Treatment of Subjects With Extensive Stage Small Cell Lung Cancer (KEYNOTE-604)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Small Cell Lung Cancer (SCLC)
Keywords: Extensive stage small cell lung cancer (ES-SCLC)
Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death Ligand 1 (PDL1, PD-L1)
Programmed Cell Death Ligand 2 (PDL2, PD-L2)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2017-02-28
Enrollment: 453
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 safety and efficacy of pembrolizumab plus standard of care (SOC) chemotherapy (etoposide/platinum \[EP\]) in participants with newly diagnosed extensive stage small cell lung cancer (ES-SCLC) who have not previously received systemic therapy for this malignancy.

The primary study hypotheses are that pembrolizumab+EP prolongs Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) and Overall Survival (OS) compared with placebo+EP in adult participants with ES-SCLC. In this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

With protocol Amendment 07 (03-Oct-2018), the outcome measure of "Change from Baseline at Weeks 12 and 24 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale" was replaced with a single time point analysis at Week 18.


Eligibility criteria: Inclusion Criteria:

* Has a documented new diagnosis of SCLC by histology or cytology from brushing, washing, or needle aspiration of a defined lesion. Participants who do not have histology samples (defined as core or excisional biopsy, or resections) will need to undergo a new biopsy to provide a tissue sample.
* Has extensive-stage disease defined as Stage IV (T any, N any, M 1a/b) by the American Joint Committee on Cancer (AJCC), Seventh Edition
* Has ≥1 lesion that meets the criteria for measurable, as defined by RECIST 1.1, and is appropriate for selection as a target lesion, as determined by local site investigator/radiology assessment
* Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
* Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Has a life expectancy of ≥3 months
* Has adequate organ function
* Female and male participants of childbearing potential must be willing to use an adequate method of contraception, starting with the first dose of study treatment through 120 days after the last dose of study treatment and up to 180 days after last dose of chemotherapeutic agents

Exclusion Criteria:

* Has received prior systemic therapy for the treatment of SCLC
* Is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment for another health-related problem
* Is expected to require any other form of antineoplastic therapy for SCLC, including radiation therapy, while on study. (Prophylactic cranial irradiation will be possible for those participants with stable disease or better at the completion of the 4 cycles of chemotherapy with or without pembrolizumab.)
* Has known central nervous system (ie, brain and/or spinal cord) metastases and/or carcinomatous meningitis. Participants with brain metastases may participate only if they satisfy all of the following:
* Has completed treatment (eg, whole brain radiation treatment \[WBRT\], stereotactic radiosurgery, or equivalent) ≥14 days prior to the first dose of study treatment,
* Has no evidence of new or enlarging brain metastases confirmed by post-treatment repeat brain imaging performed ≥3 weeks after pre-treatment brain imaging, and
* Is neurologically stable without the need for steroids for ≥7 days before first dose of study treatment.
* Has had major surgery within 3 weeks prior to receiving the first dose of study treatment or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study treatment.
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
* Has a known history of interstitial lung disease
* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
* Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment.
* Has a known history of, or active, neurologic paraneoplastic syndrome
* Has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, and/or abdominal carcinomatosis
* Has a history of a severe hypersensitivity reaction to treatment with another monoclonal antibody
* Is taking chronic systemic steroids (in doses exceeding 10 mg daily of prednisone equivalent) within 7 days prior to the first dose of study treatment
* Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
* Has received a live vaccine within 30 days prior to the first dose of study treatment
* Has received prior therapy with an anti-programmed cell death protein-1 (anti-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 co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], tumor necrosis factor receptor superfamily member 9 \[TNFRSF9, OX-40, CD137\]) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial
* Has severe hypersensitivity (Grade ≥3) to pembrolizumab and/or any of its excipients
* 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 a known history of active TB (Bacillus Tuberculosis)
* Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study starting with the screening visit through 120 days after the last dose of study treatment through and up to 180 days after last dose of chemotherapeutic agents

Primary outcomes:
measure: Progression-free Survival (PFS) 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 30.5 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 30.5 months
Secondary outcomes:
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 30.5 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 30.5 months
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to approximately 30.5 months
measure: Number of Participants Discontinuing Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to approximately 26 months
measure: Number of Participants Experiencing Any Grade 3 to 5 Adverse Events (AE) as Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE 4.03)
timeFrame: Up to approximately 30.5 months
measure: Change From Baseline at Week 18 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale
timeFrame: Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 18
measure: Change From Baseline at Week 12 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale
timeFrame: Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 12
measure: Change From Baseline at Week 24 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale
timeFrame: Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 24
measure: Time to True Deterioration (TTD) in the Composite Endpoint of Cough, Chest Pain, and Dyspnea Using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and Lung Cancer Module 13 (QLQ-LC13)
timeFrame: Day 1 of Cycles 1-9, Day 1 of every other cycle for Cycles 10-17 and 30 days after last dose of study treatment (Up to approximately 27 months)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Health Medical Group Oncology, LLC ( Site 8000)
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center ( Site 1215)
state: Illinois
city: Evanston
country: United States
facility: North Shore University Health System ( Site 1216)
state: Illinois
city: Munster
country: United States
facility: Community Hospital ( Site 1207)
state: Indiana
city: Baltimore
country: United States
facility: Weinberg Cancer Institute at Franklin Square ( Site 1210)
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital ( Site 1203)
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center ( Site 1206)
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute [Boston] ( Site 1201)
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan ( Site 1217)
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System ( Site 1221)
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, PA ( Site 8001)
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic ( Site 1205)
state: Mississippi
city: Saint Louis
country: United States
facility: Mercy Hospital Saint Louis ( Site 1213)
state: Missouri
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada ( Site 8004)
state: Nevada
city: Basking Ridge
country: United States
facility: Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1226)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 1225)
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Einstein Center for Cancer Care - Main site ( Site 1204)
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center ( Site 1222)
state: New York
city: Commack
country: United States
facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 1227)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Cancer Center ( Site 1229)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center ( Site 1211)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Cancer Center - Rockville Centre ( Site 1228)
state: New York
city: Durham
country: United States
facility: Duke University Medical Center ( Site 1214)
state: North Carolina
city: Greenville
country: United States
facility: Bon Secours St. Francis Health Sytem ( Site 1212)
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 1230)
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology ( Site 8002)
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8003)
state: Texas
city: Blacktown
country: Australia
facility: Blacktown Hospital ( Site 0004)
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Centre ( Site 0001)
state: New South Wales
city: Murdoch
country: Australia
facility: St John of God ( Site 0006)
state: Western Australia
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital ( Site 0002)
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne ( Site 0005)
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba ( Site 0159)
state: Manitoba
city: Halifax
country: Canada
facility: Nova Scotia Health Authority ( Site 0157)
state: Nova Scotia
city: Brampton
country: Canada
facility: William Osler Health System (Brampton Civic Hospital) ( Site 0161)
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre ( Site 0155)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute ( Site 0151)
state: Ontario
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie-Centre ( Site 0152)
state: Quebec
city: Lévis
country: Canada
facility: CISSS-CA Hotel Dieu de Levis ( Site 0154)
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0158)
state: Quebec
city: St-Jerome
country: Canada
facility: St. Jerome Medical Research Inc. ( Site 0160)
state: Quebec
city: Santiago
country: Chile
facility: Instituto Nacional del Cancer ( Site 0207)
state: Region Metropolitana
city: Santiago
country: Chile
facility: Health and Care Chile ( Site 0202)
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez FALP ( Site 0203)
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile ( Site 0206)
city: Talca
country: Chile
facility: Clinica Universidad Catolica del Maule ( Site 0208)
city: Lille
country: France
facility: CHRU de Lille - Hopital Albert Calmette ( Site 0353)
city: Limoges
country: France
facility: C.H.R.U. De Limoges ( Site 0358)
city: Nantes
country: France
facility: CHU Nantes - Hopital Laennec ( Site 0363)
city: Nice
country: France
facility: Centre Antoine Lacassagne ( Site 0362)
city: Paris
country: France
facility: Hopital Tenon ( Site 0360)
city: Reims
country: France
facility: Institut de Cancerologie Jean-Godinot ( Site 0351)
city: Toulouse
country: France
facility: CHU de Toulouse - Hopital Larrey ( Site 0354)
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin ( Site 0403)
city: Dresden
country: Germany
facility: Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0411)
city: Duesseldorf
country: Germany
facility: Florence Nightingale Krankenhaus ( Site 0413)
city: Gera
country: Germany
facility: SRH Waldklinikum Gera GmbH ( Site 0405)
city: Hamburg
country: Germany
facility: Asklepios Klinikum Harburg ( Site 0412)
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0401)
city: Marburg
country: Germany
facility: Philipps-Universitat Marburg ( Site 0414)
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen ( Site 0404)
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet ( Site 0453)
state: Pest
city: Budapest
country: Hungary
facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0452)
city: Budapest
country: Hungary
facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0458)
city: Budapest
country: Hungary
facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0459)
city: Farkasgyepu
country: Hungary
facility: Veszprem Megyei Tudogyogyintezet ( Site 0454)
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz ( Site 0460)
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0456)
city: Szolnok
country: Hungary
facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0451)
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Korhaz ( Site 0457)
city: Dublin
country: Ireland
facility: St Vincents University Hospital ( Site 1456)
city: Dublin
country: Ireland
facility: St James Hospital ( Site 1452)
city: Beer Sheva
country: Israel
facility: Soroka Medical Center ( Site 0505)
city: Haifa
country: Israel
facility: Ramban Medical Center - Dept. Hemato. & B. Marrow Transplant ( Site 0502)
city: Kfar Saba
country: Israel
facility: Meir Medical Center ( Site 0503)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 0504)
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center. ( Site 0501)
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center ( Site 0615)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 0613)
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 0614)
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 0609)
state: Fukuoka
city: Akashi
country: Japan
facility: Hyogo Cancer Center ( Site 0611)
state: Hyogo
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 0618)
state: Kanagawa
city: Sendai
country: Japan
facility: Sendai Kousei Hospital ( Site 0602)
state: Miyagi
city: Sakai
country: Japan
facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0608)
state: Osaka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0607)
state: Shizuoka
city: Ube
country: Japan
facility: National Hospital Organization Yamaguchi Ube Medical Center ( Site 0601)
state: Yamaguchi
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center ( Site 0617)
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital ( Site 0604)
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 0610)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 0616)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 0606)
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital ( Site 0612)
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital ( Site 0905)
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 0904)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 0903)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 0901)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 0902)
city: Christchurch
country: New Zealand
facility: Canterbury Regional Cancer & Blood Services ( Site 0701)
city: Wieliszew
country: Poland
facility: Mazowiecki Szpital Onkologiczny ( Site 0757)
state: Mazowieckie
city: Konin
country: Poland
facility: Przychodnia Lekarska Komed ( Site 0769)
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 0768)
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 0767)
city: Poznan
country: Poland
facility: SKPP UM im. Karola Marcinkowkiego w Poznaniu ( Site 0766)
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0762)
city: Torun
country: Poland
facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 0756)
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 0751)
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 0771)
city: Belgorod
country: Russian Federation
facility: Belgorod Regional Oncology Dispensary ( Site 0804)
city: Moscow
country: Russian Federation
facility: N.N. Blokhin NMRCO ( Site 0801)
city: Pyatigorsk
country: Russian Federation
facility: SBI of Stavropol region Pyatigorskiy Oncologic dispensary ( Site 0811)
city: Saint Petersburg
country: Russian Federation
facility: SBHI Leningrad Regional Clinical Hospital ( Site 0803)
city: Saint Petersburg
country: Russian Federation
facility: Municipal Clinical Oncology Center ( Site 0802)
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran Canaria ( Site 0952)
state: Gran Canaria
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario de A Coruna ( Site 0953)
city: Barcelona
country: Spain
facility: Hospital del Mar ( Site 0956)
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron ( Site 0951)
city: Jaen
country: Spain
facility: Hospital Ciudad de Jaen ( Site 0957)
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon ( Site 0958)
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz ( Site 0954)
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia ( Site 0955)
city: Chur
country: Switzerland
facility: Kantonsspital Graubuenden ( Site 1403)
city: Lausanne
country: Switzerland
facility: CHUV Centre Hospitalier Universitaire Vaudois ( Site 1405)
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich ( Site 1404)
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F. ( Site 1005)
city: Taichung
country: Taiwan
facility: China Medical University Hospital. ( Site 1003)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 1007)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 1004)
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center Liuying ( Site 1006)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 1001)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 1002)
city: Izmir
country: Turkey
facility: Ege Universitesi Tıp Fakultesi ( Site 1052)
state: Bornova
city: Adana
country: Turkey
facility: Baskent University Adana Dr. Turgut Noyan EAH ( Site 1057)
city: Ankara
country: Turkey
facility: Ankara UTF ( Site 1055)
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1060)
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH ( Site 1053)
city: Edirne
country: Turkey
facility: Trakya Uni. Tip Fakultesi ( Site 1063)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1058)
city: Istanbul
country: Turkey
facility: Medipol Hastanesi ( Site 1066)
city: Istanbul
country: Turkey
facility: Medeniyet Uni. Goztepe Egitim ve Arast. Hast. ( Site 1064)
city: Izmir
country: Turkey
facility: Medical Park Izmir Hospital ( Site 1051)
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi ( Site 1061)
city: Malatya
country: Turkey
facility: Inonu Universitesi Tip Fakultesi ( Site 1059)
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital ( Site 1162)
city: Leeds
country: United Kingdom
facility: St James s University Hospital ( Site 1161)
city: London
country: United Kingdom
facility: North Middlesex Hospital ( Site 1151)
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital ( Site 1155)
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre ( Site 1156)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Rudin CM, Awad MM, Navarro A, Gottfried M, Peters S, Csoszi T, Cheema PK, Rodriguez-Abreu D, Wollner M, Yang JC, Mazieres J, Orlandi FJ, Luft A, Gumus M, Kato T, Kalemkerian GP, Luo Y, Ebiana V, Pietanza MC, Kim HR; KEYNOTE-604 Investigators. Pembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study. J Clin Oncol. 2020 Jul 20;38(21):2369-2379. doi: 10.1200/JCO.20.00793. Epub 2020 May 29.