Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab Plus Etoposide/Platinum Versus Etoposide/Platinum in Subjects With Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
2 other identifiers
interventional
1,351
33 countries
221
Brief Summary
The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2011
Longer than P75 for phase_3
221 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2011
CompletedFirst Posted
Study publicly available on registry
October 12, 2011
CompletedStudy Start
First participant enrolled
December 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2015
CompletedResults Posted
Study results publicly available
July 18, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2017
CompletedJuly 8, 2020
July 1, 2020
3.3 years
October 10, 2011
March 7, 2016
July 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy
Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Randomization until date of death, up to March 2015, approximately 38 months
Secondary Outcomes (2)
Overall Survival in All Randomized Participants
From randomization until date of death, up to March 2015, approximately 38 months
Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy
From randomization until disease progression, up to March 2015, approximately 38 months
Study Arms (2)
Ipilimumab+Etoposide+Cisplatin/Carboplatin
EXPERIMENTALIpilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin
PLACEBO COMPARATORPlacebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
Interventions
Eligibility Criteria
You may qualify if:
- Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
- Eastern Cooperative Oncology Group (ECOG) of 0 or 1
You may not qualify if:
- Prior systemic therapy for lung cancer
- Symptomatic Central Nervous System (CNS) metastases
- History of autoimmune disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (225)
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
Sutter Medical Center
Auburn, California, 95602, United States
UCSD Moores Cancer Center
La Jolla, California, 92093, United States
University Of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Florida Cancer Specialists S.
Fort Myers, Florida, 33916, United States
Cancer Specialists, LLC
Jacksonville, Florida, 32256, United States
Lake City Cancer Care
Lake City, Florida, 32024, United States
Florida Cancer Specialists
St. Petersburg, Florida, 33705, United States
Medical Oncology, LLC
Augusta, Georgia, 30901, United States
Quincy Medical Group
Quincy, Illinois, 62301, United States
Presence Medical Group Hematology Oncology
Skokie, Illinois, 60077, United States
SIU School Of Medicine
Springfield, Illinois, 62794-9678, United States
St. Francis Medical Group Oncology And Hematology Specialist
Indianapolis, Indiana, 46237, United States
Cancer Center Of Kansas
Wichita, Kansas, 67214, United States
Ashland Bellefonte Cancer Center
Ashland, Kentucky, 41101, United States
University Of Kentucky
Lexington, Kentucky, 40536-0093, United States
Montgomery Cancer Center
Mount Sterling, Kentucky, 40353, United States
St Joseph Mercy Hospital
Ypsilanti, Michigan, 48197, United States
St. Luke'S Cancer Institute
Kansas City, Missouri, 64111, United States
Southeast Nebraska Hematology & Oncology Consultants, P.C.
Lincoln, Nebraska, 68510, United States
Regional Cancer Care Associates, LLC/Cherry Hill Division
Cherry Hill, New Jersey, 08003, United States
Memorial Sloan Kettering Nassau
New York, New York, 10065, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Oncology Hematology Care, Incorporated
Cincinnati, Ohio, 45242, United States
University Hospitals
Cleveland, Ohio, 44106, United States
Signal Point Clinical Research Center, Llc
Middletown, Ohio, 45042, United States
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, 74104, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Kaiser Permanente
Portland, Oregon, 97227, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
Associated in Oncology and Hematology
Chattanooga, Tennessee, 37421, United States
The Jones Clinic, PC
Germantown, Tennessee, 38138, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
Henry-Joyce Cancer Center
Nashville, Tennessee, 37232, United States
University Of Texas, M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
Joe Arrington Cancer Research And Treatment Center
Lubbock, Texas, 79410, United States
Huntsman Cancer Hospital
Salt Lake City, Utah, 84112, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506, United States
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Berazategui, Buenos Aires, B1884BBF, Argentina
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Buenos Aires, C1226ANZ, Argentina
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Buenos Aires, C1280AEB, Argentina
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Provincia de Sante Fe, S2000DSV, Argentina
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Kogarah, New South Wales, 2217, Australia
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Wollongong, New South Wales, 2500, Australia
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Chermside, Queensland, 4032, Australia
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Bedford Park, South Australia, 5042, Australia
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Fitzroy, Victoria, 3065, Australia
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Wodonga, Victoria, 3690, Australia
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Perth, Western Australia, 6009, Australia
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Linz, 4020, Austria
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Salzburg, 5020, Austria
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Vienna, 1130, Austria
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Vienna, 1145, Austria
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Brussels, 1090, Belgium
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Edegem, 2650, Belgium
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Leuven, 3000, Belgium
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Sint-Niklaas, 9100, Belgium
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Yvoir, 5530, Belgium
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Passo Fundo, RS, 99010-260, Brazil
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Sao Paulo/SP, CEP 01246000, Brazil
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SP, 12245-750, Brazil
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Montreal, Quebec, H2L 4M1, Canada
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Montreal, Quebec, H2W 1S6, Canada
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Viña del Mar, Región de Valparaíso, Region de Valparaiso, 2540364, Chile
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Santiago, 8360160, Chile
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Santiago, 8420383, Chile
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Guangzhou, Guangdong, 510060, China
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Guangzhou, Guangdong, 510080, China
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Harbin, Heilongjiang, 150084, China
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Wuhan, Hubei, 430023, China
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Nangjing, Jiangsu, 210002, China
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Suzhou, Jiangsu, 215006, China
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Changchun, Jilin, 130012, China
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Xi'an, Shaanxi, 710038, China
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Xi'an, Shaanxi, 710061, China
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Chengdu, Sichuan, 610041, China
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Ürümqi, Xinjiang, 830011, China
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Hangzhou, Zhejiang, 310009, China
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Hangzhou, Zhejiang, China
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Beijing, 100032, China
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Beijing, 100071, China
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Beijing, 100142, China
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Beijing, 100853, China
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Shanghai, 200030, China
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Shanghai, 200433, China
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Córdoba, Colombia
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Ostrava - Poruba, 70852, Czechia
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Prague, 180 81, Czechia
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Caen, 14076, France
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Rennes, 35033, France
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Toulouse, 31059, France
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Vandœuvre-lès-Nancy, 54511, France
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Bad Berka, 99438, Germany
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Bochum, 44791, Germany
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Dresden, 01307, Germany
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Erlangen, 91054, Germany
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Frankfurt am Main, 60590, Germany
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Gauting, 82131, Germany
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Großhansdorf, 22927, Germany
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Hamburg, 20246, Germany
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Heidelberg, 69126, Germany
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Kassel, 34125, Germany
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Mainz, 55131, Germany
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Mannheim, 68167, Germany
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München, 81925, Germany
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Oldenburg, 26121, Germany
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Ulm, 89081, Germany
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Hong Kong, Hong Kong
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Kowloon, Hong Kong
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Budapest, 1121, Hungary
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Budapest, 1125, Hungary
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Budapest, H-1121, Hungary
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Farkasgyepű, 8582, Hungary
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Mátraháza, 3233, Hungary
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Pécs, H-7623, Hungary
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Sopron, 9400, Hungary
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Szolnok, H-5000, Hungary
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Dublin, 4, Ireland
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Dublin, 8, Ireland
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Limerick, Ireland
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Beersheba, 84101, Israel
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Kfar Saba, 44281, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Ẕerifin, 70300, Israel
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Livorno, 57100, Italy
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Lucca, 55100, Italy
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Meldola (FC), 47014, Italy
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Siena, 53100, Italy
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Nagoya, Aichi-ken, 4600001, Japan
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Nagoya, Aichi-ken, 4648681, Japan
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Kashiwa, Chiba, 2778577, Japan
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Matsuyama, Ehime, 7910280, Japan
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Sapporo, Hokkaido, 0608648, Japan
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Kanazawa, Ishikawa-ken, 9208641, Japan
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Yokohama, Kanagawa, 2360051, Japan
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Yokohama, Kanagawa, 2408555, Japan
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Natori-shi, Miyagi, 981-1293, Japan
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Kurashiki-shi, Okayama-ken, 7010192, Japan
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Kurashiki-shi, Okayama-ken, 710-8602, Japan
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Hirakata-shi, Osaka, 5731191, Japan
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Takatsuki, Osaka, 5698686, Japan
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Sunto-gun, Shizuoka, 4118777, Japan
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Chuo-ku, Tokyo, 104-0045, Japan
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Ube-shi, Yamaguchi, 7550241, Japan
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Akashi, Hyogo, 673-8558, Japan
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Fukoka, 811-1395, Japan
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Fukuoka, 8128582, Japan
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Osaka, 5898511, Japan
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Oskaka, 5340021, Japan
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Sapporo, Hokkaido, 0030804, Japan
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Sendai, Miyagi, 980-0873, Japan
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Tokyo, 135-8550, Japan
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Guadalajara, Jalisco, 44280, Mexico
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San Luis Potosi, S.l.p., C.P. 78218, Mexico
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's-Hertogenbosch, 5223 GZ, Netherlands
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Breda, 4818 CK, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Cercado, Peru
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Lima, 027, Peru
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Lima, Lima 41, Peru
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Elblag, 82-300, Poland
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Karkow, 31-202, Poland
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Lublin, 20-950, Poland
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Otwock, 05-400, Poland
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Poznan, 60-569, Poland
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Torun, 87-100, Poland
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Warsaw, 02-781, Poland
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Coimbra, 3041853, Portugal
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Lisbon, 1099-023, Portugal
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Cluj-Napoca, Cluj, 400058, Romania
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Craiova, Dolj, 200385, Romania
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Bucharest, Romania
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Cluj-Napoca, 400015, Romania
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Chelyabinsk, 454087, Russia
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Krasnodar, 350040, Russia
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Kursk, 305035, Russia
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Moscow, 115478, Russia
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Pyatigorsk, 35702, Russia
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Saint Petersburg, 194291, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197758, Russia
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Saint Petersburg, 198255, Russia
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Port Elizabeth, Eastern Cape, 6045, South Africa
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Cape Town, Western Cape, 7925, South Africa
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Pretoria, 0002, South Africa
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Goyang-si, Gyeonggji-do, 410-769, South Korea
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Hwasun-eup, Hwasun-gun, Jeollanam-do, 519-763, South Korea
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Busan, 602-739, South Korea
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Seoul, 120-752, South Korea
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Seoul, 135-710, South Korea
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Seoul, 136-705, South Korea
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Seoul, 138-736, South Korea
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Suwon, 442-723, South Korea
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Suwon, 443-721, South Korea
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A Coruña, Galicia, 15006, Spain
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Barcelona, 08035, Spain
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Benidorm-alicante, 03501, Spain
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Castellon, 12002, Spain
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Lleida, 25198, Spain
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Majadahonda, 28222, Spain
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Málaga, 29010, Spain
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Valencia, 46017, Spain
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Linköping, 58185, Sweden
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Stockholm, 17176, Sweden
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Uppsala, 75185, Sweden
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Basel, 4031, Switzerland
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Winterthur, 8401, Switzerland
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Zurich, 8091, Switzerland
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Changhua, R.O.C., Taiwan
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Taichung, 40705, Taiwan
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Taipei, 100, Taiwan
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Taoyuan, 33305, Taiwan
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Chiang Mai, 50200, Thailand
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Songkhla, 90110, Thailand
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Withington, Manchester, M20 4BX, United Kingdom
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London, N18 1QX, United Kingdom
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London, SW3 6JJ, United Kingdom
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Preston, PR2 9HT, United Kingdom
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Sutton, SM2 5PT, United Kingdom
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Truro, TR1 3LJ, United Kingdom
Related Publications (1)
Reck M, Luft A, Szczesna A, Havel L, Kim SW, Akerley W, Pietanza MC, Wu YL, Zielinski C, Thomas M, Felip E, Gold K, Horn L, Aerts J, Nakagawa K, Lorigan P, Pieters A, Kong Sanchez T, Fairchild J, Spigel D. Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol. 2016 Nov 1;34(31):3740-3748. doi: 10.1200/JCO.2016.67.6601.
PMID: 27458307DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- BMS Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2011
First Posted
October 12, 2011
Study Start
December 13, 2011
Primary Completion
March 19, 2015
Study Completion
May 17, 2017
Last Updated
July 8, 2020
Results First Posted
July 18, 2016
Record last verified: 2020-07