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)
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)
5 other identifiers
interventional
453
19 countries
148
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2017
Typical duration for phase_3
148 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2017
CompletedFirst Posted
Study publicly available on registry
February 28, 2017
CompletedStudy Start
First participant enrolled
May 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2019
CompletedResults Posted
Study results publicly available
December 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2021
CompletedOctober 3, 2022
August 1, 2022
2.6 years
February 23, 2017
November 25, 2020
September 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD, as determined by RECIST 1.1, was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. For this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The PFS was calculated using the non-parametric Kaplan-Meier method for censored data and presented for the first course of study treatment per protocol.
Up to approximately 30.5 months
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow up. The OS was calculated using the non-parametric Kaplan-Meier method for censored data and presented for the first course of study treatment per protocol.
Up to approximately 30.5 months
Secondary Outcomes (9)
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)
Up to approximately 30.5 months
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)
Up to approximately 30.5 months
Number of Participants Who Experienced an Adverse Event (AE)
Up to approximately 30.5 months
Number of Participants Discontinuing Study Treatment Due to an Adverse Event (AE)
Up to approximately 26 months
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)
Up to approximately 30.5 months
- +4 more secondary outcomes
Study Arms (2)
Pembrolizumab+EP
EXPERIMENTALDuring each 21-day cycle, participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1). Participants who stop pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stop after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, are eligible for up to an additional 1 year of treatment after progressive disease if they meet the criteria for retreatment.
Placebo+EP
ACTIVE COMPARATORDuring each 21-day cycle, participants receive placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1).
Interventions
IV infusion on Day 1 of each cycle prior to chemotherapy
IV infusion on Day 1 of each cycle
IV infusion on Days 1, 2 and 3 of each cycle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (148)
Baptist Health Medical Group Oncology, LLC ( Site 8000)
Miami, Florida, 33176, United States
Rush University Medical Center ( Site 1215)
Chicago, Illinois, 60612, United States
North Shore University Health System ( Site 1216)
Evanston, Illinois, 60201, United States
Community Hospital ( Site 1207)
Munster, Indiana, 46321, United States
Weinberg Cancer Institute at Franklin Square ( Site 1210)
Baltimore, Maryland, 21237, United States
Massachusetts General Hospital ( Site 1203)
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center ( Site 1206)
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute [Boston] ( Site 1201)
Boston, Massachusetts, 02215, United States
University of Michigan ( Site 1217)
Ann Arbor, Michigan, 48109-5936, United States
Henry Ford Health System ( Site 1221)
Detroit, Michigan, 48202, United States
Minnesota Oncology Hematology, PA ( Site 8001)
Minneapolis, Minnesota, 55404, United States
Hattiesburg Clinic ( Site 1205)
Hattiesburg, Mississippi, 39401, United States
Mercy Hospital Saint Louis ( Site 1213)
St Louis, Missouri, 63141, United States
Comprehensive Cancer Centers of Nevada ( Site 8004)
Henderson, Nevada, 89074, United States
Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1226)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 1225)
Middletown, New Jersey, 07748, United States
Memorial Sloan-Kettering Cancer Center at Commack ( Site 1227)
Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center ( Site 1229)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center ( Site 1211)
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center - Rockville Centre ( Site 1228)
Rockville Centre, New York, 11570, United States
Montefiore Einstein Center for Cancer Care - Main site ( Site 1204)
The Bronx, New York, 10461, United States
Montefiore Medical Center ( Site 1222)
The Bronx, New York, 10467, United States
Duke University Medical Center ( Site 1214)
Durham, North Carolina, 27710, United States
Bon Secours St. Francis Health Sytem ( Site 1212)
Greenville, South Carolina, 29607, United States
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 1230)
Nashville, Tennessee, 37203, United States
Texas Oncology ( Site 8002)
Austin, Texas, 78745, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8003)
Dallas, Texas, 75246, United States
Blacktown Hospital ( Site 0004)
Blacktown, New South Wales, 2148, Australia
Southern Medical Day Care Centre ( Site 0001)
Wollongong, New South Wales, 2500, Australia
St John of God ( Site 0006)
Murdoch, Western Australia, 6150, Australia
Lyell McEwin Hospital ( Site 0002)
Elizabeth Vale, 5112, Australia
St Vincents Hospital Melbourne ( Site 0005)
Fitzroy, 3065, Australia
Cancer Care Manitoba ( Site 0159)
Winnipeg, Manitoba, R3E 0V9, Canada
Nova Scotia Health Authority ( Site 0157)
Halifax, Nova Scotia, B3H 1V7, Canada
William Osler Health System (Brampton Civic Hospital) ( Site 0161)
Brampton, Ontario, L6R 3J7, Canada
Kingston Health Sciences Centre ( Site 0155)
Kingston, Ontario, K7L 2V7, Canada
Sunnybrook Research Institute ( Site 0151)
Toronto, Ontario, M4N 3M5, Canada
CISSS de la Monteregie-Centre ( Site 0152)
Greenfield Park, Quebec, J4V 2H1, Canada
CISSS-CA Hotel Dieu de Levis ( Site 0154)
Lévis, Quebec, G6V 3Z1, Canada
CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0158)
Montreal, Quebec, H3T 1M5, Canada
St. Jerome Medical Research Inc. ( Site 0160)
Saint-Jérôme, Quebec, J7Z 5T3, Canada
Instituto Nacional del Cancer ( Site 0207)
Santiago, Santiago Metropolitan, 8380455, Chile
Health and Care Chile ( Site 0202)
Santiago, 7500006, Chile
Fundacion Arturo Lopez Perez FALP ( Site 0203)
Santiago, 7500921, Chile
Pontificia Universidad Catolica de Chile ( Site 0206)
Santiago, 8330032, Chile
Clinica Universidad Catolica del Maule ( Site 0208)
Talca, 3465584, Chile
CHRU de Lille - Hopital Albert Calmette ( Site 0353)
Lille, 59037, France
C.H.R.U. De Limoges ( Site 0358)
Limoges, 87042, France
CHU Nantes - Hopital Laennec ( Site 0363)
Nantes, 44805, France
Centre Antoine Lacassagne ( Site 0362)
Nice, 06189, France
Hopital Tenon ( Site 0360)
Paris, 75020, France
Institut de Cancerologie Jean-Godinot ( Site 0351)
Reims, 51726, France
CHU de Toulouse - Hopital Larrey ( Site 0354)
Toulouse, 31059, France
Evangelische Lungenklinik Berlin ( Site 0403)
Berlin, 13125, Germany
Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0411)
Dresden, 01307, Germany
Florence Nightingale Krankenhaus ( Site 0413)
Düsseldorf, 40489, Germany
SRH Waldklinikum Gera GmbH ( Site 0405)
Gera, 07548, Germany
Asklepios Klinikum Harburg ( Site 0412)
Hamburg, 21075, Germany
Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0401)
Heidelberg, 69126, Germany
Philipps-Universitat Marburg ( Site 0414)
Marburg, 35032, Germany
Universitaetsklinikum Tuebingen ( Site 0404)
Tübingen, 72076, Germany
Orszagos Onkologiai Intezet ( Site 0453)
Budapest, Pest County, 1122, Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0452)
Budapest, 1121, Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0458)
Budapest, 1121, Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0459)
Budapest, 1121, Hungary
Veszprem Megyei Tudogyogyintezet ( Site 0454)
Farkasgyepű, 8582, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 0460)
Győr, 9023, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0456)
Székesfehérvár, 8000, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0451)
Szolnok, 5000, Hungary
Zala Megyei Szent Rafael Korhaz ( Site 0457)
Zalaegerszeg, 8900, Hungary
St Vincents University Hospital ( Site 1456)
Dublin, D04 Y8V0, Ireland
St James Hospital ( Site 1452)
Dublin, D08 K0Y5, Ireland
Soroka Medical Center ( Site 0505)
Beersheba, 8489501, Israel
Ramban Medical Center - Dept. Hemato. & B. Marrow Transplant ( Site 0502)
Haifa, 3525408, Israel
Meir Medical Center ( Site 0503)
Kfar Saba, 4428164, Israel
Rabin Medical Center ( Site 0504)
Petah Tikva, 5262000, Israel
Chaim Sheba Medical Center. ( Site 0501)
Ramat Gan, 5265601, Israel
National Hospital Organization Nagoya Medical Center ( Site 0615)
Nagoya, Aichi-ken, 460-0001, Japan
National Cancer Center Hospital East ( Site 0613)
Kashiwa, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center ( Site 0614)
Matsuyama, Ehime, 791-0280, Japan
Kurume University Hospital ( Site 0609)
Kurume, Fukuoka, 830-0011, Japan
Hyogo Cancer Center ( Site 0611)
Akashi, Hyōgo, 673-8558, Japan
Kanagawa Cancer Center ( Site 0618)
Yokohama, Kanagawa, 241-8515, Japan
Sendai Kousei Hospital ( Site 0602)
Sendai, Miyagi, 980-0873, Japan
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0608)
Sakai, Osaka, 591-8555, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 0607)
Sunto-gun, Shizuoka, 411-8777, Japan
National Hospital Organization Yamaguchi Ube Medical Center ( Site 0601)
Ube, Yamaguchi, 755-0241, Japan
National Hospital Organization Kyushu Medical Center ( Site 0617)
Fukuoka, 810-8563, Japan
Hiroshima University Hospital ( Site 0604)
Hiroshima, 734-8551, Japan
Niigata Cancer Center Hospital ( Site 0610)
Niigata, 951-8566, Japan
Osaka International Cancer Institute ( Site 0616)
Osaka, 541-8567, Japan
The Cancer Institute Hospital of JFCR ( Site 0606)
Tokyo, 135-8550, Japan
Wakayama Medical University Hospital ( Site 0612)
Wakayama, 641-8509, Japan
Canterbury Regional Cancer & Blood Services ( Site 0701)
Christchurch, 8011, New Zealand
Mazowiecki Szpital Onkologiczny ( Site 0757)
Wieliszew, Masovian Voivodeship, 05-135, Poland
Przychodnia Lekarska Komed ( Site 0769)
Konin, 62-500, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 0768)
Krakow, 31-202, Poland
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 0767)
Lublin, 20-090, Poland
SKPP UM im. Karola Marcinkowkiego w Poznaniu ( Site 0766)
Poznan, 60-569, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0762)
Poznan, 60-569, Poland
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 0756)
Torun, 87-100, Poland
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 0751)
Warsaw, 02-781, Poland
Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 0771)
Wroclaw, 53-413, Poland
Belgorod Regional Oncology Dispensary ( Site 0804)
Belgorod, 308010, Russia
N.N. Blokhin NMRCO ( Site 0801)
Moscow, 115478, Russia
SBI of Stavropol region Pyatigorskiy Oncologic dispensary ( Site 0811)
Pyatigorsk, 357502, Russia
SBHI Leningrad Regional Clinical Hospital ( Site 0803)
Saint Petersburg, 194291, Russia
Municipal Clinical Oncology Center ( Site 0802)
Saint Petersburg, 198255, Russia
Inje University Haeundae Paik Hospital ( Site 0905)
Busan, 48108, South Korea
National Cancer Center ( Site 0904)
Goyang-si, 10408, South Korea
Severance Hospital Yonsei University Health System ( Site 0903)
Seoul, 03722, South Korea
Asan Medical Center ( Site 0901)
Seoul, 05505, South Korea
Samsung Medical Center ( Site 0902)
Seoul, 06351, South Korea
Hospital Universitario Insular de Gran Canaria ( Site 0952)
Las Palmas de Gran Canaria, Gran Canaria, 35016, Spain
Complejo Hospitalario Universitario de A Coruna ( Site 0953)
A Coruña, 15006, Spain
Hospital del Mar ( Site 0956)
Barcelona, 08003, Spain
Hospital Universitari Vall d Hebron ( Site 0951)
Barcelona, 08035, Spain
Hospital Ciudad de Jaen ( Site 0957)
Jaén, 23007, Spain
Hospital General Universitario Gregorio Maranon ( Site 0958)
Madrid, 28007, Spain
Hospital Universitario Fundacion Jimenez Diaz ( Site 0954)
Madrid, 28040, Spain
Hospital Clinico Universitario de Valencia ( Site 0955)
Valencia, 46010, Spain
Kantonsspital Graubuenden ( Site 1403)
Chur, 7000, Switzerland
CHUV Centre Hospitalier Universitaire Vaudois ( Site 1405)
Lausanne, 1011, Switzerland
Universitaetsspital Zuerich ( Site 1404)
Zurich, 8091, Switzerland
Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F. ( Site 1005)
Kaohsiung City, 83301, Taiwan
China Medical University Hospital. ( Site 1003)
Taichung, 40447, Taiwan
Taichung Veterans General Hospital ( Site 1007)
Taichung, 40705, Taiwan
National Cheng Kung University Hospital ( Site 1004)
Tainan, 704, Taiwan
Chi Mei Medical Center Liuying ( Site 1006)
Tainan, 736, Taiwan
National Taiwan University Hospital ( Site 1001)
Taipei, 10002, Taiwan
Taipei Veterans General Hospital ( Site 1002)
Taipei, 11217, Taiwan
Ege Universitesi Tıp Fakultesi ( Site 1052)
Izmir, Bornova, 35100, Turkey (Türkiye)
Baskent University Adana Dr. Turgut Noyan EAH ( Site 1057)
Adana, 01250, Turkey (Türkiye)
Ankara UTF ( Site 1055)
Ankara, 06100, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1060)
Ankara, 06100, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH ( Site 1053)
Ankara, 06200, Turkey (Türkiye)
Trakya Uni. Tip Fakultesi ( Site 1063)
Edirne, 22030, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1058)
Istanbul, 34098, Turkey (Türkiye)
Medipol Hastanesi ( Site 1066)
Istanbul, 34214, Turkey (Türkiye)
Medeniyet Uni. Goztepe Egitim ve Arast. Hast. ( Site 1064)
Istanbul, 34722, Turkey (Türkiye)
Medical Park Izmir Hospital ( Site 1051)
Izmir, 35575, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi ( Site 1061)
Kocaeli, 41380, Turkey (Türkiye)
Inonu Universitesi Tip Fakultesi ( Site 1059)
Malatya, 44280, Turkey (Türkiye)
Birmingham Heartlands Hospital ( Site 1162)
Birmingham, B9 5SS, United Kingdom
St James s University Hospital ( Site 1161)
Leeds, LS9 7TF, United Kingdom
North Middlesex Hospital ( Site 1151)
London, N18 1QX, United Kingdom
Maidstone Hospital ( Site 1155)
Maidstone, ME16 9QQ, United Kingdom
Mount Vernon Cancer Centre ( Site 1156)
Northwood, HA6 2RN, United Kingdom
Related Publications (1)
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.
PMID: 32468956RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme LLC
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2017
First Posted
February 28, 2017
Study Start
May 2, 2017
Primary Completion
December 2, 2019
Study Completion
September 21, 2021
Last Updated
October 3, 2022
Results First Posted
December 22, 2020
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf