Lung Cancer Clinical Trial

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)

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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

453

Study ID:

NCT03066778

Recruitment Status:

Completed

Sponsor:

Merck Sharp & Dohme LLC

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There are 143 Locations for this study

See Locations Near You

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, 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)
Saint 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
Montefiore Einstein Center for Cancer Care - Main site ( Site 1204)
Bronx New York, 10461, United States
Montefiore Medical Center ( Site 1222)
Bronx New York, 10467, 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
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 0, Canada
Nova Scotia Health Authority ( Site 0157)
Halifax Nova Scotia, B3H 1, Canada
William Osler Health System (Brampton Civic Hospital) ( Site 0161)
Brampton Ontario, L6R 3, Canada
Kingston Health Sciences Centre ( Site 0155)
Kingston Ontario, K7L 2, Canada
Sunnybrook Research Institute ( Site 0151)
Toronto Ontario, M4N 3, Canada
CISSS de la Monteregie-Centre ( Site 0152)
Greenfield Park Quebec, J4V 2, Canada
CISSS-CA Hotel Dieu de Levis ( Site 0154)
Lévis Quebec, G6V 3, Canada
CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0158)
Montreal Quebec, H3T 1, Canada
St. Jerome Medical Research Inc. ( Site 0160)
St-Jerome Quebec, J7Z 5, Canada
Instituto Nacional del Cancer ( Site 0207)
Santiago Region Metropolitana, 83804, Chile
Health and Care Chile ( Site 0202)
Santiago , 75000, Chile
Fundacion Arturo Lopez Perez FALP ( Site 0203)
Santiago , 75009, Chile
Pontificia Universidad Catolica de Chile ( Site 0206)
Santiago , 83300, Chile
Clinica Universidad Catolica del Maule ( Site 0208)
Talca , 34655, 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)
Duesseldorf , 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)
Tuebingen , 72076, Germany
Orszagos Onkologiai Intezet ( Site 0453)
Budapest Pest, 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)
Farkasgyepu , 8582, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 0460)
Gyor , 9023, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0456)
Szekesfehervar , 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 Y, Ireland
St James Hospital ( Site 1452)
Dublin , D08 K, Ireland
Soroka Medical Center ( Site 0505)
Beer Sheva , 84895, Israel
Ramban Medical Center - Dept. Hemato. & B. Marrow Transplant ( Site 0502)
Haifa , 35254, Israel
Meir Medical Center ( Site 0503)
Kfar Saba , 44281, Israel
Rabin Medical Center ( Site 0504)
Petah Tikva , 52620, Israel
Chaim Sheba Medical Center. ( Site 0501)
Ramat-Gan , 52656, Israel
National Hospital Organization Nagoya Medical Center ( Site 0615)
Nagoya Aichi, 460-0, Japan
National Cancer Center Hospital East ( Site 0613)
Kashiwa Chiba, 277-8, Japan
National Hospital Organization Shikoku Cancer Center ( Site 0614)
Matsuyama Ehime, 791-0, Japan
Kurume University Hospital ( Site 0609)
Kurume Fukuoka, 830-0, Japan
Hyogo Cancer Center ( Site 0611)
Akashi Hyogo, 673-8, Japan
Kanagawa Cancer Center ( Site 0618)
Yokohama Kanagawa, 241-8, Japan
Sendai Kousei Hospital ( Site 0602)
Sendai Miyagi, 980-0, Japan
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0608)
Sakai Osaka, 591-8, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 0607)
Sunto-gun Shizuoka, 411-8, Japan
National Hospital Organization Yamaguchi Ube Medical Center ( Site 0601)
Ube Yamaguchi, 755-0, Japan
National Hospital Organization Kyushu Medical Center ( Site 0617)
Fukuoka , 810-8, Japan
Hiroshima University Hospital ( Site 0604)
Hiroshima , 734-8, Japan
Niigata Cancer Center Hospital ( Site 0610)
Niigata , 951-8, Japan
Osaka International Cancer Institute ( Site 0616)
Osaka , 541-8, Japan
The Cancer Institute Hospital of JFCR ( Site 0606)
Tokyo , 135-8, Japan
Wakayama Medical University Hospital ( Site 0612)
Wakayama , 641-8, Japan
Inje University Haeundae Paik Hospital ( Site 0905)
Busan , 48108, Korea, Republic of
National Cancer Center ( Site 0904)
Goyang-si , 10408, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 0903)
Seoul , 03722, Korea, Republic of
Asan Medical Center ( Site 0901)
Seoul , 05505, Korea, Republic of
Samsung Medical Center ( Site 0902)
Seoul , 06351, Korea, Republic of
Canterbury Regional Cancer & Blood Services ( Site 0701)
Christchurch , 8011, New Zealand
Mazowiecki Szpital Onkologiczny ( Site 0757)
Wieliszew Mazowieckie, 05-13, Poland
Przychodnia Lekarska Komed ( Site 0769)
Konin , 62-50, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 0768)
Krakow , 31-20, Poland
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 0767)
Lublin , 20-09, Poland
SKPP UM im. Karola Marcinkowkiego w Poznaniu ( Site 0766)
Poznan , 60-56, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0762)
Poznan , 60-56, Poland
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 0756)
Torun , 87-10, Poland
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 0751)
Warszawa , 02-78, Poland
Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 0771)
Wroclaw , 53-41, Poland
Belgorod Regional Oncology Dispensary ( Site 0804)
Belgorod , 30801, Russian Federation
N.N. Blokhin NMRCO ( Site 0801)
Moscow , 11547, Russian Federation
SBI of Stavropol region Pyatigorskiy Oncologic dispensary ( Site 0811)
Pyatigorsk , 35750, Russian Federation
SBHI Leningrad Regional Clinical Hospital ( Site 0803)
Saint Petersburg , 19429, Russian Federation
Municipal Clinical Oncology Center ( Site 0802)
Saint Petersburg , 19825, Russian Federation
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 Coruna , 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)
Jaen , 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)
Zuerich , 8091, Switzerland
Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F. ( Site 1005)
Kaohsiung , 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
Baskent University Adana Dr. Turgut Noyan EAH ( Site 1057)
Adana , 01250, Turkey
Ankara UTF ( Site 1055)
Ankara , 06100, Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1060)
Ankara , 06100, Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH ( Site 1053)
Ankara , 06200, Turkey
Trakya Uni. Tip Fakultesi ( Site 1063)
Edirne , 22030, Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1058)
Istanbul , 34098, Turkey
Medipol Hastanesi ( Site 1066)
Istanbul , 34214, Turkey
Medeniyet Uni. Goztepe Egitim ve Arast. Hast. ( Site 1064)
Istanbul , 34722, Turkey
Medical Park Izmir Hospital ( Site 1051)
Izmir , 35575, Turkey
Kocaeli Universitesi Tip Fakultesi ( Site 1061)
Kocaeli , 41380, Turkey
Inonu Universitesi Tip Fakultesi ( Site 1059)
Malatya , 44280, Turkey
Birmingham Heartlands Hospital ( Site 1162)
Birmingham , B9 5S, United Kingdom
St James s University Hospital ( Site 1161)
Leeds , LS9 7, United Kingdom
North Middlesex Hospital ( Site 1151)
London , N18 1, United Kingdom
Maidstone Hospital ( Site 1155)
Maidstone , ME16 , United Kingdom
Mount Vernon Cancer Centre ( Site 1156)
Northwood , HA6 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

453

Study ID:

NCT03066778

Recruitment Status:

Completed

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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