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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)

Primary Purpose

Small Cell Lung Cancer (SCLC)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Normal saline solution
Carboplatin
Cisplatin
Etoposide
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer (SCLC) focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baptist Health Medical Group Oncology, LLC ( Site 8000)
  • Rush University Medical Center ( Site 1215)
  • North Shore University Health System ( Site 1216)
  • Community Hospital ( Site 1207)
  • Weinberg Cancer Institute at Franklin Square ( Site 1210)
  • Massachusetts General Hospital ( Site 1203)
  • Beth Israel Deaconess Medical Center ( Site 1206)
  • Dana-Farber Cancer Institute [Boston] ( Site 1201)
  • University of Michigan ( Site 1217)
  • Henry Ford Health System ( Site 1221)
  • Minnesota Oncology Hematology, PA ( Site 8001)
  • Hattiesburg Clinic ( Site 1205)
  • Mercy Hospital Saint Louis ( Site 1213)
  • Comprehensive Cancer Centers of Nevada ( Site 8004)
  • Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1226)
  • Memorial Sloan Kettering Cancer Center- Monmouth ( Site 1225)
  • Montefiore Einstein Center for Cancer Care - Main site ( Site 1204)
  • Montefiore Medical Center ( Site 1222)
  • Memorial Sloan-Kettering Cancer Center at Commack ( Site 1227)
  • Memorial Sloan Kettering Cancer Center ( Site 1229)
  • Memorial Sloan Kettering Cancer Center ( Site 1211)
  • Memorial Sloan Kettering Cancer Center - Rockville Centre ( Site 1228)
  • Duke University Medical Center ( Site 1214)
  • Bon Secours St. Francis Health Sytem ( Site 1212)
  • Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 1230)
  • Texas Oncology ( Site 8002)
  • Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8003)
  • Blacktown Hospital ( Site 0004)
  • Southern Medical Day Care Centre ( Site 0001)
  • St John of God ( Site 0006)
  • Lyell McEwin Hospital ( Site 0002)
  • St Vincents Hospital Melbourne ( Site 0005)
  • Cancer Care Manitoba ( Site 0159)
  • Nova Scotia Health Authority ( Site 0157)
  • William Osler Health System (Brampton Civic Hospital) ( Site 0161)
  • Kingston Health Sciences Centre ( Site 0155)
  • Sunnybrook Research Institute ( Site 0151)
  • CISSS de la Monteregie-Centre ( Site 0152)
  • CISSS-CA Hotel Dieu de Levis ( Site 0154)
  • CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0158)
  • St. Jerome Medical Research Inc. ( Site 0160)
  • Instituto Nacional del Cancer ( Site 0207)
  • Health and Care Chile ( Site 0202)
  • Fundacion Arturo Lopez Perez FALP ( Site 0203)
  • Pontificia Universidad Catolica de Chile ( Site 0206)
  • Clinica Universidad Catolica del Maule ( Site 0208)
  • CHRU de Lille - Hopital Albert Calmette ( Site 0353)
  • C.H.R.U. De Limoges ( Site 0358)
  • CHU Nantes - Hopital Laennec ( Site 0363)
  • Centre Antoine Lacassagne ( Site 0362)
  • Hopital Tenon ( Site 0360)
  • Institut de Cancerologie Jean-Godinot ( Site 0351)
  • CHU de Toulouse - Hopital Larrey ( Site 0354)
  • Evangelische Lungenklinik Berlin ( Site 0403)
  • Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0411)
  • Florence Nightingale Krankenhaus ( Site 0413)
  • SRH Waldklinikum Gera GmbH ( Site 0405)
  • Asklepios Klinikum Harburg ( Site 0412)
  • Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0401)
  • Philipps-Universitat Marburg ( Site 0414)
  • Universitaetsklinikum Tuebingen ( Site 0404)
  • Orszagos Onkologiai Intezet ( Site 0453)
  • Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0452)
  • Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0458)
  • Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0459)
  • Veszprem Megyei Tudogyogyintezet ( Site 0454)
  • Petz Aladar Megyei Oktato Korhaz ( Site 0460)
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0456)
  • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0451)
  • Zala Megyei Szent Rafael Korhaz ( Site 0457)
  • St Vincents University Hospital ( Site 1456)
  • St James Hospital ( Site 1452)
  • Soroka Medical Center ( Site 0505)
  • Ramban Medical Center - Dept. Hemato. & B. Marrow Transplant ( Site 0502)
  • Meir Medical Center ( Site 0503)
  • Rabin Medical Center ( Site 0504)
  • Chaim Sheba Medical Center. ( Site 0501)
  • National Hospital Organization Nagoya Medical Center ( Site 0615)
  • National Cancer Center Hospital East ( Site 0613)
  • National Hospital Organization Shikoku Cancer Center ( Site 0614)
  • Kurume University Hospital ( Site 0609)
  • Hyogo Cancer Center ( Site 0611)
  • Kanagawa Cancer Center ( Site 0618)
  • Sendai Kousei Hospital ( Site 0602)
  • National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0608)
  • Shizuoka Cancer Center Hospital and Research Institute ( Site 0607)
  • National Hospital Organization Yamaguchi Ube Medical Center ( Site 0601)
  • National Hospital Organization Kyushu Medical Center ( Site 0617)
  • Hiroshima University Hospital ( Site 0604)
  • Niigata Cancer Center Hospital ( Site 0610)
  • Osaka International Cancer Institute ( Site 0616)
  • The Cancer Institute Hospital of JFCR ( Site 0606)
  • Wakayama Medical University Hospital ( Site 0612)
  • Inje University Haeundae Paik Hospital ( Site 0905)
  • National Cancer Center ( Site 0904)
  • Severance Hospital Yonsei University Health System ( Site 0903)
  • Asan Medical Center ( Site 0901)
  • Samsung Medical Center ( Site 0902)
  • Canterbury Regional Cancer & Blood Services ( Site 0701)
  • Mazowiecki Szpital Onkologiczny ( Site 0757)
  • Przychodnia Lekarska Komed ( Site 0769)
  • Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 0768)
  • Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 0767)
  • SKPP UM im. Karola Marcinkowkiego w Poznaniu ( Site 0766)
  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0762)
  • Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 0756)
  • Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 0751)
  • Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 0771)
  • Belgorod Regional Oncology Dispensary ( Site 0804)
  • N.N. Blokhin NMRCO ( Site 0801)
  • SBI of Stavropol region Pyatigorskiy Oncologic dispensary ( Site 0811)
  • SBHI Leningrad Regional Clinical Hospital ( Site 0803)
  • Municipal Clinical Oncology Center ( Site 0802)
  • Hospital Universitario Insular de Gran Canaria ( Site 0952)
  • Complejo Hospitalario Universitario de A Coruna ( Site 0953)
  • Hospital del Mar ( Site 0956)
  • Hospital Universitari Vall d Hebron ( Site 0951)
  • Hospital Ciudad de Jaen ( Site 0957)
  • Hospital General Universitario Gregorio Maranon ( Site 0958)
  • Hospital Universitario Fundacion Jimenez Diaz ( Site 0954)
  • Hospital Clinico Universitario de Valencia ( Site 0955)
  • Kantonsspital Graubuenden ( Site 1403)
  • CHUV Centre Hospitalier Universitaire Vaudois ( Site 1405)
  • Universitaetsspital Zuerich ( Site 1404)
  • Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F. ( Site 1005)
  • China Medical University Hospital. ( Site 1003)
  • Taichung Veterans General Hospital ( Site 1007)
  • National Cheng Kung University Hospital ( Site 1004)
  • Chi Mei Medical Center Liuying ( Site 1006)
  • National Taiwan University Hospital ( Site 1001)
  • Taipei Veterans General Hospital ( Site 1002)
  • Ege Universitesi Tıp Fakultesi ( Site 1052)
  • Baskent University Adana Dr. Turgut Noyan EAH ( Site 1057)
  • Ankara UTF ( Site 1055)
  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1060)
  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH ( Site 1053)
  • Trakya Uni. Tip Fakultesi ( Site 1063)
  • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1058)
  • Medipol Hastanesi ( Site 1066)
  • Medeniyet Uni. Goztepe Egitim ve Arast. Hast. ( Site 1064)
  • Medical Park Izmir Hospital ( Site 1051)
  • Kocaeli Universitesi Tip Fakultesi ( Site 1061)
  • Inonu Universitesi Tip Fakultesi ( Site 1059)
  • Birmingham Heartlands Hospital ( Site 1162)
  • St James s University Hospital ( Site 1161)
  • North Middlesex Hospital ( Site 1151)
  • Maidstone Hospital ( Site 1155)
  • Mount Vernon Cancer Centre ( Site 1156)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pembrolizumab+EP

Placebo+EP

Arm Description

During 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.

During 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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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)
ORR was defined as the percentage of participants who achieve a best objective response of complete response (CR) or partial response (PR) per RECIST 1.1. CR was defined as the disappearance of all target lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions taking as a reference the baseline sum diameters. In 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 ORR was calculated using the Miettinen & Nurminen method stratified by type of platinum therapy (carboplatin or cisplatin), baseline ECOG performance status (0 or 1), and baseline LDH (≤ or > upper limit of normal) and presented for the first course of study treatment per protocol.
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)
DOR was defined as the time from first documented evidence of a Complete Response (CR) or Partial Response (PR) per RECIST 1.1 until progressive disease (PD) per RECIST 1.1 or death due to any cause, whichever occurred first. CR was defined as the disappearance of all target lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions taking as a reference the baseline sum diameters. PD 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 ≥1 new lesions was also considered PD. In 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 DOR was calculated using the product-limit (Kaplan-Meier) method for censored data and is presented for the first course of study treatment per protocol.
Number of Participants Who Experienced an Adverse Event (AE)
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants who experienced an AE was reported for each arm according to the treatment received and is presented for the first course of study treatment per protocol.
Number of Participants Discontinuing Study Treatment Due to an Adverse Event (AE)
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants who discontinued due to an AE was reported for each arm according to the treatment received and is presented for the first course of study treatment per protocol.
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)
The CTCAE uses Grades 1 through 5 correlating to AE severity criteria. Grade 1=mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2=moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3=severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4=life-threatening consequences; urgent intervention indicated. Grade 5=death related to AE. The number of participants who experienced any Grade 3 to 5 AE was reported for each arm according to the treatment received and is presented for the first course of study treatment per protocol.
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
EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores are transformed to a range of 0 to 100 using a standard EORTC algorithm. Change from baseline scores were calculated using a constrained longitudinal data analysis (cLDA) model. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. Data are presented for the first course of study treatment per protocol.
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
EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores were transformed to a range of 0 to 100 using a standard EORTC algorithm. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. Per protocol, data were to be presented for the first course of study treatment.
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
EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores were transformed to a range of 0 to 100 using a standard EORTC algorithm. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. Per protocol, data were to be presented for the first course of study treatment.
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)
TTD in patient-reported lung cancer symptoms of cough (QLQ-LC-13 Item 1), chest pain (QLQ-LC-13 Item 10), and dyspnea (QLQ-C30 Item 8) was a composite endpoint defined as the time to first onset of ≥10 point deterioration from baseline in an item confirmed by a second adjacent ≥10 point deterioration. The QLQ-LC13 consists of 13 measures of lung cancer symptoms and side effects from chemotherapy and radiation. It is scored on a 4-point scale (1=none, 2=a little, 3=quite a bit, 4=very much). Scores were transformed to a range of 0 to 100 using a standard algorithm. Higher scores represented increasing symptom severity. TTD was calculated using the product-limit Kaplan-Meier method for censored data and is presented for the first course of study treatment per protocol.

Full Information

First Posted
February 23, 2017
Last Updated
September 2, 2022
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03066778
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
December 2, 2019 (Actual)
Study Completion Date
September 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
453 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab+EP
Arm Type
Experimental
Arm Description
During 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.
Arm Title
Placebo+EP
Arm Type
Active Comparator
Arm Description
During 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).
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
IV infusion on Day 1 of each cycle prior to chemotherapy
Intervention Type
Drug
Intervention Name(s)
Normal saline solution
Intervention Description
IV infusion on Day 1 of each cycle prior to chemotherapy
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
PARAPLATIN®
Intervention Description
IV infusion on Day 1 of each cycle
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
PLATINOL®
Intervention Description
IV infusion on Day 1 of each cycle
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
TOPOSAR™
Intervention Description
IV infusion on Days 1, 2 and 3 of each cycle
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Up to approximately 30.5 months
Title
Overall Survival (OS)
Description
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.
Time Frame
Up to approximately 30.5 months
Secondary Outcome Measure Information:
Title
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)
Description
ORR was defined as the percentage of participants who achieve a best objective response of complete response (CR) or partial response (PR) per RECIST 1.1. CR was defined as the disappearance of all target lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions taking as a reference the baseline sum diameters. In 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 ORR was calculated using the Miettinen & Nurminen method stratified by type of platinum therapy (carboplatin or cisplatin), baseline ECOG performance status (0 or 1), and baseline LDH (≤ or > upper limit of normal) and presented for the first course of study treatment per protocol.
Time Frame
Up to approximately 30.5 months
Title
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)
Description
DOR was defined as the time from first documented evidence of a Complete Response (CR) or Partial Response (PR) per RECIST 1.1 until progressive disease (PD) per RECIST 1.1 or death due to any cause, whichever occurred first. CR was defined as the disappearance of all target lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions taking as a reference the baseline sum diameters. PD 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 ≥1 new lesions was also considered PD. In 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 DOR was calculated using the product-limit (Kaplan-Meier) method for censored data and is presented for the first course of study treatment per protocol.
Time Frame
Up to approximately 30.5 months
Title
Number of Participants Who Experienced an Adverse Event (AE)
Description
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants who experienced an AE was reported for each arm according to the treatment received and is presented for the first course of study treatment per protocol.
Time Frame
Up to approximately 30.5 months
Title
Number of Participants Discontinuing Study Treatment Due to an Adverse Event (AE)
Description
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants who discontinued due to an AE was reported for each arm according to the treatment received and is presented for the first course of study treatment per protocol.
Time Frame
Up to approximately 26 months
Title
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)
Description
The CTCAE uses Grades 1 through 5 correlating to AE severity criteria. Grade 1=mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2=moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3=severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4=life-threatening consequences; urgent intervention indicated. Grade 5=death related to AE. The number of participants who experienced any Grade 3 to 5 AE was reported for each arm according to the treatment received and is presented for the first course of study treatment per protocol.
Time Frame
Up to approximately 30.5 months
Title
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
Description
EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores are transformed to a range of 0 to 100 using a standard EORTC algorithm. Change from baseline scores were calculated using a constrained longitudinal data analysis (cLDA) model. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. Data are presented for the first course of study treatment per protocol.
Time Frame
Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 18
Title
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
Description
EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores were transformed to a range of 0 to 100 using a standard EORTC algorithm. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. Per protocol, data were to be presented for the first course of study treatment.
Time Frame
Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 12
Title
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
Description
EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores were transformed to a range of 0 to 100 using a standard EORTC algorithm. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. Per protocol, data were to be presented for the first course of study treatment.
Time Frame
Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 24
Title
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)
Description
TTD in patient-reported lung cancer symptoms of cough (QLQ-LC-13 Item 1), chest pain (QLQ-LC-13 Item 10), and dyspnea (QLQ-C30 Item 8) was a composite endpoint defined as the time to first onset of ≥10 point deterioration from baseline in an item confirmed by a second adjacent ≥10 point deterioration. The QLQ-LC13 consists of 13 measures of lung cancer symptoms and side effects from chemotherapy and radiation. It is scored on a 4-point scale (1=none, 2=a little, 3=quite a bit, 4=very much). Scores were transformed to a range of 0 to 100 using a standard algorithm. Higher scores represented increasing symptom severity. TTD was calculated using the product-limit Kaplan-Meier method for censored data and is presented for the first course of study treatment per protocol.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Baptist Health Medical Group Oncology, LLC ( Site 8000)
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Rush University Medical Center ( Site 1215)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
North Shore University Health System ( Site 1216)
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Community Hospital ( Site 1207)
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Weinberg Cancer Institute at Franklin Square ( Site 1210)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Massachusetts General Hospital ( Site 1203)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center ( Site 1206)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute [Boston] ( Site 1201)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan ( Site 1217)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5936
Country
United States
Facility Name
Henry Ford Health System ( Site 1221)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minnesota Oncology Hematology, PA ( Site 8001)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Hattiesburg Clinic ( Site 1205)
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Mercy Hospital Saint Louis ( Site 1213)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada ( Site 8004)
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1226)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 1225)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Montefiore Einstein Center for Cancer Care - Main site ( Site 1204)
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center ( Site 1222)
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center at Commack ( Site 1227)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center ( Site 1229)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center ( Site 1211)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center - Rockville Centre ( Site 1228)
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Duke University Medical Center ( Site 1214)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Bon Secours St. Francis Health Sytem ( Site 1212)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 1230)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology ( Site 8002)
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8003)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Blacktown Hospital ( Site 0004)
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Southern Medical Day Care Centre ( Site 0001)
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
St John of God ( Site 0006)
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Lyell McEwin Hospital ( Site 0002)
City
Elizabeth Vale
ZIP/Postal Code
5112
Country
Australia
Facility Name
St Vincents Hospital Melbourne ( Site 0005)
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Cancer Care Manitoba ( Site 0159)
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Nova Scotia Health Authority ( Site 0157)
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
William Osler Health System (Brampton Civic Hospital) ( Site 0161)
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
Kingston Health Sciences Centre ( Site 0155)
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Sunnybrook Research Institute ( Site 0151)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
CISSS de la Monteregie-Centre ( Site 0152)
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
CISSS-CA Hotel Dieu de Levis ( Site 0154)
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0158)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1M5
Country
Canada
Facility Name
St. Jerome Medical Research Inc. ( Site 0160)
City
St-Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 5T3
Country
Canada
Facility Name
Instituto Nacional del Cancer ( Site 0207)
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
8380455
Country
Chile
Facility Name
Health and Care Chile ( Site 0202)
City
Santiago
ZIP/Postal Code
7500006
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez FALP ( Site 0203)
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Pontificia Universidad Catolica de Chile ( Site 0206)
City
Santiago
ZIP/Postal Code
8330032
Country
Chile
Facility Name
Clinica Universidad Catolica del Maule ( Site 0208)
City
Talca
ZIP/Postal Code
3465584
Country
Chile
Facility Name
CHRU de Lille - Hopital Albert Calmette ( Site 0353)
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
C.H.R.U. De Limoges ( Site 0358)
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
CHU Nantes - Hopital Laennec ( Site 0363)
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Antoine Lacassagne ( Site 0362)
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Hopital Tenon ( Site 0360)
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Institut de Cancerologie Jean-Godinot ( Site 0351)
City
Reims
ZIP/Postal Code
51726
Country
France
Facility Name
CHU de Toulouse - Hopital Larrey ( Site 0354)
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Evangelische Lungenklinik Berlin ( Site 0403)
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0411)
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Florence Nightingale Krankenhaus ( Site 0413)
City
Duesseldorf
ZIP/Postal Code
40489
Country
Germany
Facility Name
SRH Waldklinikum Gera GmbH ( Site 0405)
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Asklepios Klinikum Harburg ( Site 0412)
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0401)
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Philipps-Universitat Marburg ( Site 0414)
City
Marburg
ZIP/Postal Code
35032
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen ( Site 0404)
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Orszagos Onkologiai Intezet ( Site 0453)
City
Budapest
State/Province
Pest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0452)
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0458)
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0459)
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Veszprem Megyei Tudogyogyintezet ( Site 0454)
City
Farkasgyepu
ZIP/Postal Code
8582
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz ( Site 0460)
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0456)
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0451)
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Zala Megyei Szent Rafael Korhaz ( Site 0457)
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
St Vincents University Hospital ( Site 1456)
City
Dublin
ZIP/Postal Code
D04 Y8V0
Country
Ireland
Facility Name
St James Hospital ( Site 1452)
City
Dublin
ZIP/Postal Code
D08 K0Y5
Country
Ireland
Facility Name
Soroka Medical Center ( Site 0505)
City
Beer Sheva
ZIP/Postal Code
8489501
Country
Israel
Facility Name
Ramban Medical Center - Dept. Hemato. & B. Marrow Transplant ( Site 0502)
City
Haifa
ZIP/Postal Code
3525408
Country
Israel
Facility Name
Meir Medical Center ( Site 0503)
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center ( Site 0504)
City
Petah Tikva
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Chaim Sheba Medical Center. ( Site 0501)
City
Ramat-Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
National Hospital Organization Nagoya Medical Center ( Site 0615)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
National Cancer Center Hospital East ( Site 0613)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center ( Site 0614)
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Kurume University Hospital ( Site 0609)
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Hyogo Cancer Center ( Site 0611)
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Kanagawa Cancer Center ( Site 0618)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Sendai Kousei Hospital ( Site 0602)
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0608)
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Shizuoka Cancer Center Hospital and Research Institute ( Site 0607)
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Hospital Organization Yamaguchi Ube Medical Center ( Site 0601)
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-0241
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center ( Site 0617)
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Hiroshima University Hospital ( Site 0604)
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Niigata Cancer Center Hospital ( Site 0610)
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Osaka International Cancer Institute ( Site 0616)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR ( Site 0606)
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Wakayama Medical University Hospital ( Site 0612)
City
Wakayama
ZIP/Postal Code
641-8509
Country
Japan
Facility Name
Inje University Haeundae Paik Hospital ( Site 0905)
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
National Cancer Center ( Site 0904)
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 0903)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 0901)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 0902)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Canterbury Regional Cancer & Blood Services ( Site 0701)
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Mazowiecki Szpital Onkologiczny ( Site 0757)
City
Wieliszew
State/Province
Mazowieckie
ZIP/Postal Code
05-135
Country
Poland
Facility Name
Przychodnia Lekarska Komed ( Site 0769)
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 0768)
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 0767)
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
SKPP UM im. Karola Marcinkowkiego w Poznaniu ( Site 0766)
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0762)
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 0756)
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 0751)
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 0771)
City
Wroclaw
ZIP/Postal Code
53-413
Country
Poland
Facility Name
Belgorod Regional Oncology Dispensary ( Site 0804)
City
Belgorod
ZIP/Postal Code
308010
Country
Russian Federation
Facility Name
N.N. Blokhin NMRCO ( Site 0801)
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
SBI of Stavropol region Pyatigorskiy Oncologic dispensary ( Site 0811)
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
SBHI Leningrad Regional Clinical Hospital ( Site 0803)
City
Saint Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Municipal Clinical Oncology Center ( Site 0802)
City
Saint Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Hospital Universitario Insular de Gran Canaria ( Site 0952)
City
Las Palmas de Gran Canaria
State/Province
Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Facility Name
Complejo Hospitalario Universitario de A Coruna ( Site 0953)
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital del Mar ( Site 0956)
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari Vall d Hebron ( Site 0951)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Ciudad de Jaen ( Site 0957)
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon ( Site 0958)
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz ( Site 0954)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia ( Site 0955)
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Kantonsspital Graubuenden ( Site 1403)
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
CHUV Centre Hospitalier Universitaire Vaudois ( Site 1405)
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Universitaetsspital Zuerich ( Site 1404)
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F. ( Site 1005)
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
China Medical University Hospital. ( Site 1003)
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital ( Site 1007)
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital ( Site 1004)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Chi Mei Medical Center Liuying ( Site 1006)
City
Tainan
ZIP/Postal Code
736
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 1001)
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Veterans General Hospital ( Site 1002)
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Ege Universitesi Tıp Fakultesi ( Site 1052)
City
Izmir
State/Province
Bornova
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Baskent University Adana Dr. Turgut Noyan EAH ( Site 1057)
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Ankara UTF ( Site 1055)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1060)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH ( Site 1053)
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Trakya Uni. Tip Fakultesi ( Site 1063)
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1058)
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Medipol Hastanesi ( Site 1066)
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Medeniyet Uni. Goztepe Egitim ve Arast. Hast. ( Site 1064)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Medical Park Izmir Hospital ( Site 1051)
City
Izmir
ZIP/Postal Code
35575
Country
Turkey
Facility Name
Kocaeli Universitesi Tip Fakultesi ( Site 1061)
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Inonu Universitesi Tip Fakultesi ( Site 1059)
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Birmingham Heartlands Hospital ( Site 1162)
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
St James s University Hospital ( Site 1161)
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
North Middlesex Hospital ( Site 1151)
City
London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Maidstone Hospital ( Site 1155)
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre ( Site 1156)
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
32468956
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.
Results Reference
result
Links:
URL
http://merckoncologyclinicaltrials.com
Description
Merck Oncology Clinical Trials Information

Learn more about this 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)

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