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| ID | Type | Description | Link |
|---|---|---|---|
| 173744 | Registry Identifier | JAPIC-CTI | |
| MK-3475-604 | Other Identifier | Merck | |
| KEYNOTE-604 | Other Identifier | Merck | |
| 2016-004309-15 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab+EP | Experimental | 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. |
|
| Placebo+EP | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Biological | IV infusion on Day 1 of each cycle prior to chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD, as determined by RECIST 1.1, was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. For this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The PFS was calculated using the non-parametric Kaplan-Meier method for censored data and presented for the first course of study treatment per protocol. | Up to approximately 30.5 months |
| Overall Survival (OS) | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow up. The OS was calculated using the non-parametric Kaplan-Meier method for censored data and presented for the first course of study treatment per protocol. | Up to approximately 30.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Health Medical Group Oncology, LLC ( Site 8000) | Miami | Florida | 33176 | United States | ||
| Rush University Medical Center ( Site 1215) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32468956 | Result | 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. |
| Label | URL |
|---|---|
| Merck Oncology Clinical Trials Information | View source |
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One participant who was randomized to the pembrolizumab+EP arm was inadvertently treated with placebo+EP. For efficacy analyses this participant will be included in the arm they were initially randomized into and for safety analyses the participant will be included by treatment received.
Participants in the pembrolizumab+ chemotherapy (etoposide/platinum [EP]) arm were eligible to receive second course treatment with pembrolizumab if they met criteria for re-treatment. Per protocol, response, progression, or patient reported outcomes during the second course were not counted towards efficacy outcome measures and adverse events during the second course were not counted towards safety outcome measures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab+EP | During each 21-day cycle, participants received 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 stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2019 |
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| Normal saline solution | Drug | IV infusion on Day 1 of each cycle prior to chemotherapy |
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| Carboplatin | Drug | IV infusion on Day 1 of each cycle |
|
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| Cisplatin | Drug | IV infusion on Day 1 of each cycle |
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| Etoposide | Drug | IV infusion on Days 1, 2 and 3 of each cycle |
|
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| Up to approximately 30.5 months |
| Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | 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. | Up to approximately 30.5 months |
| 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. | Up to approximately 30.5 months |
| 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. | Up to approximately 26 months |
| Number of Participants Experiencing Any Grade 3 to 5 Adverse Events (AE) as Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE 4.03) | 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. | Up to approximately 30.5 months |
| 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. | Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 18 |
| 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. | Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 12 |
| 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. | Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 24 |
| 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. | 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) |
| Chicago |
| Illinois |
| 60612 |
| United States |
| North Shore University Health System ( Site 1216) | Evanston | Illinois | 60201 | United States |
| Community Hospital ( Site 1207) | Munster | Indiana | 46321 | United States |
| Weinberg Cancer Institute at Franklin Square ( Site 1210) | Baltimore | Maryland | 21237 | United States |
| Massachusetts General Hospital ( Site 1203) | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center ( Site 1206) | Boston | Massachusetts | 02215 | United States |
| Dana-Farber Cancer Institute [Boston] ( Site 1201) | Boston | Massachusetts | 02215 | United States |
| University of Michigan ( Site 1217) | Ann Arbor | Michigan | 48109-5936 | United States |
| Henry Ford Health System ( Site 1221) | Detroit | Michigan | 48202 | United States |
| Minnesota Oncology Hematology, PA ( Site 8001) | Minneapolis | Minnesota | 55404 | United States |
| Hattiesburg Clinic ( Site 1205) | Hattiesburg | Mississippi | 39401 | United States |
| Mercy Hospital Saint Louis ( Site 1213) | St Louis | Missouri | 63141 | United States |
| Comprehensive Cancer Centers of Nevada ( Site 8004) | Henderson | Nevada | 89074 | United States |
| Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1226) | Basking Ridge | New Jersey | 07920 | United States |
| Memorial Sloan Kettering Cancer Center- Monmouth ( Site 1225) | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan-Kettering Cancer Center at Commack ( Site 1227) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Cancer Center ( Site 1229) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center ( Site 1211) | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Cancer Center - Rockville Centre ( Site 1228) | Rockville Centre | New York | 11570 | United States |
| Montefiore Einstein Center for Cancer Care - Main site ( Site 1204) | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center ( Site 1222) | The Bronx | New York | 10467 | United States |
| Duke University Medical Center ( Site 1214) | Durham | North Carolina | 27710 | United States |
| Bon Secours St. Francis Health Sytem ( Site 1212) | Greenville | South Carolina | 29607 | United States |
| Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 1230) | Nashville | Tennessee | 37203 | United States |
| Texas Oncology ( Site 8002) | Austin | Texas | 78745 | United States |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8003) | Dallas | Texas | 75246 | United States |
| Blacktown Hospital ( Site 0004) | Blacktown | New South Wales | 2148 | Australia |
| Southern Medical Day Care Centre ( Site 0001) | Wollongong | New South Wales | 2500 | Australia |
| St John of God ( Site 0006) | Murdoch | Western Australia | 6150 | Australia |
| Lyell McEwin Hospital ( Site 0002) | Elizabeth Vale | 5112 | Australia |
| St Vincents Hospital Melbourne ( Site 0005) | Fitzroy | 3065 | Australia |
| Cancer Care Manitoba ( Site 0159) | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Nova Scotia Health Authority ( Site 0157) | Halifax | Nova Scotia | B3H 1V7 | Canada |
| William Osler Health System (Brampton Civic Hospital) ( Site 0161) | Brampton | Ontario | L6R 3J7 | Canada |
| Kingston Health Sciences Centre ( Site 0155) | Kingston | Ontario | K7L 2V7 | Canada |
| Sunnybrook Research Institute ( Site 0151) | Toronto | Ontario | M4N 3M5 | Canada |
| CISSS de la Monteregie-Centre ( Site 0152) | Greenfield Park | Quebec | J4V 2H1 | Canada |
| CISSS-CA Hotel Dieu de Levis ( Site 0154) | Lévis | Quebec | G6V 3Z1 | Canada |
| CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0158) | Montreal | Quebec | H3T 1M5 | Canada |
| St. Jerome Medical Research Inc. ( Site 0160) | Saint-Jérôme | Quebec | J7Z 5T3 | Canada |
| Instituto Nacional del Cancer ( Site 0207) | Santiago | Santiago Metropolitan | 8380455 | Chile |
| Health and Care Chile ( Site 0202) | Santiago | 7500006 | Chile |
| Fundacion Arturo Lopez Perez FALP ( Site 0203) | Santiago | 7500921 | Chile |
| Pontificia Universidad Catolica de Chile ( Site 0206) | Santiago | 8330032 | Chile |
| Clinica Universidad Catolica del Maule ( Site 0208) | Talca | 3465584 | Chile |
| CHRU de Lille - Hopital Albert Calmette ( Site 0353) | Lille | 59037 | France |
| C.H.R.U. De Limoges ( Site 0358) | Limoges | 87042 | France |
| CHU Nantes - Hopital Laennec ( Site 0363) | Nantes | 44805 | France |
| Centre Antoine Lacassagne ( Site 0362) | Nice | 06189 | France |
| Hopital Tenon ( Site 0360) | Paris | 75020 | France |
| Institut de Cancerologie Jean-Godinot ( Site 0351) | Reims | 51726 | France |
| CHU de Toulouse - Hopital Larrey ( Site 0354) | Toulouse | 31059 | France |
| Evangelische Lungenklinik Berlin ( Site 0403) | Berlin | 13125 | Germany |
| Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0411) | Dresden | 01307 | Germany |
| Florence Nightingale Krankenhaus ( Site 0413) | Düsseldorf | 40489 | Germany |
| SRH Waldklinikum Gera GmbH ( Site 0405) | Gera | 07548 | Germany |
| Asklepios Klinikum Harburg ( Site 0412) | Hamburg | 21075 | Germany |
| Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0401) | Heidelberg | 69126 | Germany |
| Philipps-Universitat Marburg ( Site 0414) | Marburg | 35032 | Germany |
| Universitaetsklinikum Tuebingen ( Site 0404) | Tübingen | 72076 | Germany |
| Orszagos Onkologiai Intezet ( Site 0453) | Budapest | Pest County | 1122 | Hungary |
| Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0452) | Budapest | 1121 | Hungary |
| Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0458) | Budapest | 1121 | Hungary |
| Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0459) | Budapest | 1121 | Hungary |
| Veszprem Megyei Tudogyogyintezet ( Site 0454) | Farkasgyepű | 8582 | Hungary |
| Petz Aladar Megyei Oktato Korhaz ( Site 0460) | Győr | 9023 | Hungary |
| Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0456) | Székesfehérvár | 8000 | Hungary |
| Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0451) | Szolnok | 5000 | Hungary |
| Zala Megyei Szent Rafael Korhaz ( Site 0457) | Zalaegerszeg | 8900 | Hungary |
| St Vincents University Hospital ( Site 1456) | Dublin | D04 Y8V0 | Ireland |
| St James Hospital ( Site 1452) | Dublin | D08 K0Y5 | Ireland |
| Soroka Medical Center ( Site 0505) | Beersheba | 8489501 | Israel |
| Ramban Medical Center - Dept. Hemato. & B. Marrow Transplant ( Site 0502) | Haifa | 3525408 | Israel |
| Meir Medical Center ( Site 0503) | Kfar Saba | 4428164 | Israel |
| Rabin Medical Center ( Site 0504) | Petah Tikva | 5262000 | Israel |
| Chaim Sheba Medical Center. ( Site 0501) | Ramat Gan | 5265601 | Israel |
| National Hospital Organization Nagoya Medical Center ( Site 0615) | Nagoya | Aichi-ken | 460-0001 | Japan |
| National Cancer Center Hospital East ( Site 0613) | Kashiwa | Chiba | 277-8577 | Japan |
| National Hospital Organization Shikoku Cancer Center ( Site 0614) | Matsuyama | Ehime | 791-0280 | Japan |
| Kurume University Hospital ( Site 0609) | Kurume | Fukuoka | 830-0011 | Japan |
| Hyogo Cancer Center ( Site 0611) | Akashi | Hyōgo | 673-8558 | Japan |
| Kanagawa Cancer Center ( Site 0618) | Yokohama | Kanagawa | 241-8515 | Japan |
| Sendai Kousei Hospital ( Site 0602) | Sendai | Miyagi | 980-0873 | Japan |
| National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0608) | Sakai | Osaka | 591-8555 | Japan |
| Shizuoka Cancer Center Hospital and Research Institute ( Site 0607) | Sunto-gun | Shizuoka | 411-8777 | Japan |
| National Hospital Organization Yamaguchi Ube Medical Center ( Site 0601) | Ube | Yamaguchi | 755-0241 | Japan |
| National Hospital Organization Kyushu Medical Center ( Site 0617) | Fukuoka | 810-8563 | Japan |
| Hiroshima University Hospital ( Site 0604) | Hiroshima | 734-8551 | Japan |
| Niigata Cancer Center Hospital ( Site 0610) | Niigata | 951-8566 | Japan |
| Osaka International Cancer Institute ( Site 0616) | Osaka | 541-8567 | Japan |
| The Cancer Institute Hospital of JFCR ( Site 0606) | Tokyo | 135-8550 | Japan |
| Wakayama Medical University Hospital ( Site 0612) | Wakayama | 641-8509 | Japan |
| Canterbury Regional Cancer & Blood Services ( Site 0701) | Christchurch | 8011 | New Zealand |
| Mazowiecki Szpital Onkologiczny ( Site 0757) | Wieliszew | Masovian Voivodeship | 05-135 | Poland |
| Przychodnia Lekarska Komed ( Site 0769) | Konin | 62-500 | Poland |
| Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 0768) | Krakow | 31-202 | Poland |
| Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 0767) | Lublin | 20-090 | Poland |
| SKPP UM im. Karola Marcinkowkiego w Poznaniu ( Site 0766) | Poznan | 60-569 | Poland |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0762) | Poznan | 60-569 | Poland |
| Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 0756) | Torun | 87-100 | Poland |
| Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 0751) | Warsaw | 02-781 | Poland |
| Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 0771) | Wroclaw | 53-413 | Poland |
| Belgorod Regional Oncology Dispensary ( Site 0804) | Belgorod | 308010 | Russia |
| N.N. Blokhin NMRCO ( Site 0801) | Moscow | 115478 | Russia |
| SBI of Stavropol region Pyatigorskiy Oncologic dispensary ( Site 0811) | Pyatigorsk | 357502 | Russia |
| SBHI Leningrad Regional Clinical Hospital ( Site 0803) | Saint Petersburg | 194291 | Russia |
| Municipal Clinical Oncology Center ( Site 0802) | Saint Petersburg | 198255 | Russia |
| Inje University Haeundae Paik Hospital ( Site 0905) | Busan | 48108 | South Korea |
| National Cancer Center ( Site 0904) | Goyang-si | 10408 | South Korea |
| Severance Hospital Yonsei University Health System ( Site 0903) | Seoul | 03722 | South Korea |
| Asan Medical Center ( Site 0901) | Seoul | 05505 | South Korea |
| Samsung Medical Center ( Site 0902) | Seoul | 06351 | South Korea |
| Hospital Universitario Insular de Gran Canaria ( Site 0952) | Las Palmas de Gran Canaria | Gran Canaria | 35016 | Spain |
| Complejo Hospitalario Universitario de A Coruna ( Site 0953) | A Coruña | 15006 | Spain |
| Hospital del Mar ( Site 0956) | Barcelona | 08003 | Spain |
| Hospital Universitari Vall d Hebron ( Site 0951) | Barcelona | 08035 | Spain |
| Hospital Ciudad de Jaen ( Site 0957) | Jaén | 23007 | Spain |
| Hospital General Universitario Gregorio Maranon ( Site 0958) | Madrid | 28007 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz ( Site 0954) | Madrid | 28040 | Spain |
| Hospital Clinico Universitario de Valencia ( Site 0955) | Valencia | 46010 | Spain |
| Kantonsspital Graubuenden ( Site 1403) | Chur | 7000 | Switzerland |
| CHUV Centre Hospitalier Universitaire Vaudois ( Site 1405) | Lausanne | 1011 | Switzerland |
| Universitaetsspital Zuerich ( Site 1404) | Zurich | 8091 | Switzerland |
| Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F. ( Site 1005) | Kaohsiung City | 83301 | Taiwan |
| China Medical University Hospital. ( Site 1003) | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital ( Site 1007) | Taichung | 40705 | Taiwan |
| National Cheng Kung University Hospital ( Site 1004) | Tainan | 704 | Taiwan |
| Chi Mei Medical Center Liuying ( Site 1006) | Tainan | 736 | Taiwan |
| National Taiwan University Hospital ( Site 1001) | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital ( Site 1002) | Taipei | 11217 | Taiwan |
| Ege Universitesi Tıp Fakultesi ( Site 1052) | Izmir | Bornova | 35100 | Turkey (Türkiye) |
| Baskent University Adana Dr. Turgut Noyan EAH ( Site 1057) | Adana | 01250 | Turkey (Türkiye) |
| Ankara UTF ( Site 1055) | Ankara | 06100 | Turkey (Türkiye) |
| Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1060) | Ankara | 06100 | Turkey (Türkiye) |
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH ( Site 1053) | Ankara | 06200 | Turkey (Türkiye) |
| Trakya Uni. Tip Fakultesi ( Site 1063) | Edirne | 22030 | Turkey (Türkiye) |
| Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1058) | Istanbul | 34098 | Turkey (Türkiye) |
| Medipol Hastanesi ( Site 1066) | Istanbul | 34214 | Turkey (Türkiye) |
| Medeniyet Uni. Goztepe Egitim ve Arast. Hast. ( Site 1064) | Istanbul | 34722 | Turkey (Türkiye) |
| Medical Park Izmir Hospital ( Site 1051) | Izmir | 35575 | Turkey (Türkiye) |
| Kocaeli Universitesi Tip Fakultesi ( Site 1061) | Kocaeli | 41380 | Turkey (Türkiye) |
| Inonu Universitesi Tip Fakultesi ( Site 1059) | Malatya | 44280 | Turkey (Türkiye) |
| Birmingham Heartlands Hospital ( Site 1162) | Birmingham | B9 5SS | United Kingdom |
| St James s University Hospital ( Site 1161) | Leeds | LS9 7TF | United Kingdom |
| North Middlesex Hospital ( Site 1151) | London | N18 1QX | United Kingdom |
| Maidstone Hospital ( Site 1155) | Maidstone | ME16 9QQ | United Kingdom |
| Mount Vernon Cancer Centre ( Site 1156) | Northwood | HA6 2RN | United Kingdom |
| FG001 | Placebo+EP | During each 21-day cycle, participants received 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). |
| Treated |
|
| Received Second Course of Pembrolizumab |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants randomized by intention to treat (ITT).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab+EP | During each 21-day cycle, participants received 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 stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment. |
| BG001 | Placebo+EP | During each 21-day cycle, participants received 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | An ECOG Performance Status of 0 (Fully active, able to carry on all pre-disease performance without restriction) or 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature) was required for inclusion in the study and randomization was stratified by ECOG score. | Count of Participants | Participants |
| |||||||||||||||
| Lactate Dehydrogenase (LDH) Status at Baseline | Randomization of participants in the study was stratified by LDH measurement at baseline ( ≤ or > upper limit of normal). | Count of Participants | Participants |
| |||||||||||||||
| Platinum Therapy Administered | Randomization of participants was stratified by type of platinum therapy administered during the study. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 30.5 months |
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| Primary | 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. | The analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 30.5 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 30.5 months |
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| Secondary | 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. | The analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized and experienced a CR or PR. | Posted | Median | Full Range | Months | Up to approximately 30.5 months |
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| Secondary | 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. | The analysis population consisted of all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 30.5 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis population consisted of all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 26 months |
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| Secondary | 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. | The analysis population consisted of all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 30.5 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All participants who received at least 1 dose of study medication and had non-missing assessments at baseline and Week 18. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 18 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All participants who received at least 1 dose of study medication and had non-missing assessments at baseline and Week 12. This outcome measure was replaced with a single time-point analysis at Week 18 as pre-specified with Amendment 7 of the protocol (03-Oct-2018). | Posted | Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 12 |
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| Secondary | 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. | All participants who received at least 1 dose of study medication and had non-missing assessments at baseline and Week 24. This outcome measure was replaced with a single time-point analysis at Week 18 as pre-specified with Amendment 7 of the protocol (03-Oct-2018). | Posted | Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 24 |
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| Secondary | 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. | All participants who received at least 1 dose of study medication and had non-missing assessments. | Posted | Median | 95% Confidence Interval | Months | 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) |
|
First Course: Up to 49.5 months Second Course: Up to 37.9 months First and second course dosing occurred concurrently
All-cause mortality (ACM)=all randomized participants; AE=all participants who received ≥1 dose of study treatment. Per protocol, MedDRA preferred terms neoplasm progression (NP), malignant NP, disease progression not related to study treatment are excluded. ACM was adjusted for the participant who was randomized to pembrolizumab+EP and treated with placebo+EP. AEs presented by actual treatment received. Per protocol, collection of AE and ACM were planned for first and second courses.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pembrolizumab+EP | During each 21-day cycle, participants received 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 stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment. | 196 | 227 | 111 | 223 | 221 | 223 |
| EG001 | Placebo+EP | During each 21-day cycle, participants received 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). | 212 | 226 | 89 | 223 | 216 | 223 |
| EG002 | Pembrolizumab Second Course | Participants who met the criteria for retreatment received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle for up to 1 year of treatment. | 1 | 1 | 1 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Secondary adrenocortical insufficiency | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Autoimmune uveitis | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Paracancerous pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pleural infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Serratia sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Paraneoplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Limbic encephalitis | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Autoimmune nephritis | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neurogenic bladder | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Laryngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Subacute cutaneous lupus erythematosus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Sep 2, 2022 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000077330 | Saline Solution |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ECOG = 1 |
|
| LDH = > Upper Limit of Normal |
|
| LDH Result Missing |
|
| Carboplatin |
|
| Not Treated with Platinum Therapy |
|
|
|
|
| OG001 | Placebo+EP | During each 21-day cycle, participants received 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). |
|
|
|
| OG001 | Placebo+EP | During each 21-day cycle, participants received 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). |
|
|
| OG001 | Placebo+EP | During each 21-day cycle, participants received 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). |
|
|
| OG001 | Placebo+EP | During each 21-day cycle, participants received 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). |
|
|
| OG001 | Placebo+EP | During each 21-day cycle, participants received 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). |
|
|
| OG001 | Placebo+EP | During each 21-day cycle, participants received 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). |
|
|
|
| OG001 | Placebo+EP | During each 21-day cycle, participants received 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). |
|
| OG001 | Placebo+EP | During each 21-day cycle, participants received 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). |
|
| OG001 | Placebo+EP | During each 21-day cycle, participants received 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). |
|
|
|