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.
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
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There are 143 Locations for this study
Miami Florida, 33176, United States
Chicago Illinois, 60612, United States
Evanston Illinois, 60201, United States
Munster Indiana, 46321, United States
Baltimore Maryland, 21237, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48202, United States
Minneapolis Minnesota, 55404, United States
Hattiesburg Mississippi, 39401, United States
Saint Louis Missouri, 63141, United States
Henderson Nevada, 89074, United States
Basking Ridge New Jersey, 07920, United States
Middletown New Jersey, 07748, United States
Bronx New York, 10461, United States
Bronx New York, 10467, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10065, United States
Rockville Centre New York, 11570, United States
Durham North Carolina, 27710, United States
Greenville South Carolina, 29607, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78745, United States
Dallas Texas, 75246, United States
Blacktown New South Wales, 2148, Australia
Wollongong New South Wales, 2500, Australia
Murdoch Western Australia, 6150, Australia
Elizabeth Vale , 5112, Australia
Fitzroy , 3065, Australia
Winnipeg Manitoba, R3E 0, Canada
Halifax Nova Scotia, B3H 1, Canada
Brampton Ontario, L6R 3, Canada
Kingston Ontario, K7L 2, Canada
Toronto Ontario, M4N 3, Canada
Greenfield Park Quebec, J4V 2, Canada
Lévis Quebec, G6V 3, Canada
Montreal Quebec, H3T 1, Canada
St-Jerome Quebec, J7Z 5, Canada
Santiago Region Metropolitana, 83804, Chile
Santiago , 75000, Chile
Santiago , 75009, Chile
Santiago , 83300, Chile
Talca , 34655, Chile
Lille , 59037, France
Limoges , 87042, France
Nantes , 44805, France
Nice , 06189, France
Paris , 75020, France
Reims , 51726, France
Toulouse , 31059, France
Berlin , 13125, Germany
Dresden , 01307, Germany
Duesseldorf , 40489, Germany
Gera , 07548, Germany
Hamburg , 21075, Germany
Heidelberg , 69126, Germany
Marburg , 35032, Germany
Tuebingen , 72076, Germany
Budapest Pest, 1122, Hungary
Budapest , 1121, Hungary
Budapest , 1121, Hungary
Budapest , 1121, Hungary
Farkasgyepu , 8582, Hungary
Gyor , 9023, Hungary
Szekesfehervar , 8000, Hungary
Szolnok , 5000, Hungary
Zalaegerszeg , 8900, Hungary
Dublin , D04 Y, Ireland
Dublin , D08 K, Ireland
Beer Sheva , 84895, Israel
Haifa , 35254, Israel
Kfar Saba , 44281, Israel
Petah Tikva , 52620, Israel
Ramat-Gan , 52656, Israel
Nagoya Aichi, 460-0, Japan
Kashiwa Chiba, 277-8, Japan
Matsuyama Ehime, 791-0, Japan
Kurume Fukuoka, 830-0, Japan
Akashi Hyogo, 673-8, Japan
Yokohama Kanagawa, 241-8, Japan
Sendai Miyagi, 980-0, Japan
Sakai Osaka, 591-8, Japan
Sunto-gun Shizuoka, 411-8, Japan
Ube Yamaguchi, 755-0, Japan
Fukuoka , 810-8, Japan
Hiroshima , 734-8, Japan
Niigata , 951-8, Japan
Osaka , 541-8, Japan
Tokyo , 135-8, Japan
Wakayama , 641-8, Japan
Busan , 48108, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Christchurch , 8011, New Zealand
Wieliszew Mazowieckie, 05-13, Poland
Konin , 62-50, Poland
Krakow , 31-20, Poland
Lublin , 20-09, Poland
Poznan , 60-56, Poland
Poznan , 60-56, Poland
Torun , 87-10, Poland
Warszawa , 02-78, Poland
Wroclaw , 53-41, Poland
Belgorod , 30801, Russian Federation
Moscow , 11547, Russian Federation
Pyatigorsk , 35750, Russian Federation
Saint Petersburg , 19429, Russian Federation
Saint Petersburg , 19825, Russian Federation
Las Palmas de Gran Canaria Gran Canaria, 35016, Spain
A Coruna , 15006, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Jaen , 23007, Spain
Madrid , 28007, Spain
Madrid , 28040, Spain
Valencia , 46010, Spain
Chur , 7000, Switzerland
Lausanne , 1011, Switzerland
Zuerich , 8091, Switzerland
Kaohsiung , 83301, Taiwan
Taichung , 40447, Taiwan
Taichung , 40705, Taiwan
Tainan , 704, Taiwan
Tainan , 736, Taiwan
Taipei , 10002, Taiwan
Taipei , 11217, Taiwan
Izmir Bornova, 35100, Turkey
Adana , 01250, Turkey
Ankara , 06100, Turkey
Ankara , 06100, Turkey
Ankara , 06200, Turkey
Edirne , 22030, Turkey
Istanbul , 34098, Turkey
Istanbul , 34214, Turkey
Istanbul , 34722, Turkey
Izmir , 35575, Turkey
Kocaeli , 41380, Turkey
Malatya , 44280, Turkey
Birmingham , B9 5S, United Kingdom
Leeds , LS9 7, United Kingdom
London , N18 1, United Kingdom
Maidstone , ME16 , United Kingdom
Northwood , HA6 2, United Kingdom
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