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Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Small Cell Lung Carcinoma

Intervention: Ipilimumab (Biological); Placebo matching Ipilimumab (Biological); Etoposide (Drug); Cisplatin (Drug); Carboplatin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Overall contact:
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:, Email: Clinical.Trials@bms.com

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.

Clinical Details

Official title: 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)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Overall Survival among subjects who receive at least one dose of blinded study therapy

Secondary outcome:

Overall Survival in all Randomized Subjects

Progression Free Survival per mWHO in subjects who have received at least one dose of blinded study therapy

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

For more information regarding BMS clinical trial participation, please visit www. BMSStudyConnect. com. Inclusion Criteria:

- Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)

- Eastern Cooperative Oncology Group (ECOG) of 0 or 1

Exclusion Criteria:

- Prior systemic therapy for lung cancer

- Symptomatic Central Nervous System (CNS) metastases

- History of autoimmune disease

Locations and Contacts

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:, Email: Clinical.Trials@bms.com

Local Institution, Berazategui 1884, Argentina; Completed

Local Institution, Caba 1426, Argentina; Completed

Local Institution, Ciudad Autonoma de Buenos C1280AEB, Argentina; Active, not recruiting

Local Institution, Salzburg 5020, Austria; Not yet recruiting
Site 120

Local Institution, Leuven 3000, Belgium; Active, not recruiting

Local Institution, Yvoir 5530, Belgium; Active, not recruiting

Local Institution, Sao Paulo 01246, Brazil; Active, not recruiting

Local Institution, Valparaiso 2363068, Chile; Terminated

Local Institution, Beijing 100032, China; Active, not recruiting

Local Institution, Beijing 100071, China; Active, not recruiting

Local Institution, Beijing 100853, China; Active, not recruiting

Local Institution, Shanghai 200030, China; Active, not recruiting

Local Institution, Ostrava - Poruba 70852, Czech Republic; Active, not recruiting

Local Institution, Prague 8 180 81, Czech Republic; Active, not recruiting

Local Institution, Prague 128 08, Czech Republic; Active, not recruiting

Local Institution, Caen 14076, France; Not yet recruiting
Site 173

Local Institution, Rennes Cedex 9 35033, France; Active, not recruiting

Local Institution, Toulouse Cedex 9 31059, France; Not yet recruiting
Site 174

Local Institution, Bochum 44791, Germany; Active, not recruiting

Local Institution, Gauting 82131, Germany; Active, not recruiting

Local Institution, Grosshansdorf 22927, Germany; Active, not recruiting

Local Institution, Heidelberg 69126, Germany; Active, not recruiting

Local Institution, Mannheim 68167, Germany; Active, not recruiting

Local Institution, Munchen 81925, Germany; Active, not recruiting

Local Institution, Hong Kong, Hong Kong; Active, not recruiting

Local Institution, Kowloon, Hong Kong; Active, not recruiting

Local Institution, Budapest 1125, Hungary; Recruiting
Site 096

Local Institution, Farkasgyepu 8582, Hungary; Recruiting
Site 097

Local Institution, Matrahaza 3233, Hungary; Recruiting
Site 093

Local Institution, Sopron 9400, Hungary; Recruiting
Site 094

Local Institution, Szekesfehervar 8000, Hungary; Not yet recruiting
Site 099

Local Institution, Szolnok H-5000, Hungary; Recruiting
Site 189

Local Institution, Dublin 4, Ireland; Active, not recruiting

Local Institution, Dublin 8, Ireland; Active, not recruiting

Local Institution, Kfar-saba 44281, Israel; Active, not recruiting

Local Institution, Zerifin 70300, Israel; Active, not recruiting

Local Institution, Lucca 55100, Italy; Active, not recruiting

Local Institution, Siena 53100, Italy; Active, not recruiting

Local Institution, Busan 602-739, Korea, Republic of; Active, not recruiting

Local Institution, Seoul 120-752, Korea, Republic of; Active, not recruiting

Local Institution, Seoul 136-705, Korea, Republic of; Active, not recruiting

Local Institution, Seoul 138-736, Korea, Republic of; Active, not recruiting

Local Institution, Suwon 443-721, Korea, Republic of; Active, not recruiting

Local Institution, San Luis Potosi 78419, Mexico; Not yet recruiting
Site 200

Local Institution, Eindhoven 5623 EJ, Netherlands; Active, not recruiting

Local Institution, Lima Lima 01, Peru; Terminated

Local Institution, Krakow 31202, Poland; Active, not recruiting

Local Institution, Otwock 05-400, Poland; Active, not recruiting

Local Institution, Torun 87-100, Poland; Active, not recruiting

Local Institution, Warszawa 02-781, Poland; Active, not recruiting

Local Institution, Coimbra 3041853, Portugal; Active, not recruiting

Local Institution, Cluj Napoca 400058, Romania; Active, not recruiting

Local Institution, Craiova 200385, Romania; Active, not recruiting

Local Institution, Chelyabinsk 454087, Russian Federation; Active, not recruiting

Local Institution, Krasnodar 350040, Russian Federation; Active, not recruiting

Local Institution, Moscow 115478, Russian Federation; Active, not recruiting

Local Institution, Pyatigorsk 35702, Russian Federation; Active, not recruiting

Local Institution, St. Petersburg 198255, Russian Federation; Active, not recruiting

Local Institution, St. Petersburg 194291, Russian Federation; Active, not recruiting

Local Institution, Barcelona 08035, Spain; Active, not recruiting

Local Institution, Benidorm-alicante 03501, Spain; Active, not recruiting

Local Institution, Lleida 25198, Spain; Active, not recruiting

Local Institution, Malaga 29010, Spain; Active, not recruiting

Local Institution, Stockholm 17176, Sweden; Active, not recruiting

Local Institution, Uppsala 75185, Sweden; Active, not recruiting

Local Institution, Basel 4031, Switzerland; Active, not recruiting

Local Institution, Changhua 500, Taiwan; Not yet recruiting
Site 182

Local Institution, Taichung City 40447, Taiwan; Active, not recruiting

Local Institution, Chiang Mai 50200, Thailand; Active, not recruiting

Local Institution, London N181QX, United Kingdom; Active, not recruiting

Local Institution, London SW3 6JJ, United Kingdom; Active, not recruiting

Local Institution, Preston PR2 9HT, United Kingdom; Active, not recruiting

Local Institution, Truro TR1 3LJ, United Kingdom; Active, not recruiting

Local Institution, Nagoya-shi, Aichi 4600001, Japan; Active, not recruiting

Local Institution, Malaga, Andalucia 29010, Spain; Active, not recruiting

Genesis Cancer Center, Hot Springs, Arkansas 71913, United States; Active, not recruiting

Local Institution, Beijing, Beijing 100142, China; Active, not recruiting

Sutter Auburn Faith Hospital, Auburn, California 95602, United States; Active, not recruiting

Ucsd Moores Cancer Center, La Jolla, California 92093, United States; Active, not recruiting

Local Institution, Monteria, Cordoba, Colombia; Not yet recruiting
Site 201

Local Institution, Bogota, Cundinamarca, Colombia; Not yet recruiting
Site 203

Local Institution, Port Elizabeth, Eastern Cape 6045, South Africa; Active, not recruiting

Cancer Specialists, Llc, Jacksonville, Florida 32256, United States; Active, not recruiting

Cancer Care Of North Florida, Pa, Lake City, Florida 32024, United States; Active, not recruiting

Local Institution, A Coruna, Galicia 15006, Spain; Active, not recruiting

Local Institution, Seoul, Gangnam-gu 135-710, Korea, Republic of; Active, not recruiting

Medical Oncology Associates Of Augusta,Pc, Augusta, Georgia 30901, United States; Active, not recruiting

Local Institution, Guangzhou, Guangdong 510060, China; Active, not recruiting

Local Institution, Guangzhou, Guangdong 510080, China; Active, not recruiting

Local Institution, Goyang-si, Gyeonggji-do 410-769, Korea, Republic of; Active, not recruiting

Local Institution, Harbin, Heilongjiang 150084, China; Active, not recruiting

Local Institution, Wuhan, Hubei 430023, China; Active, not recruiting

Quincy Medical Group, Quincy, Illinois 62301, United States; Active, not recruiting

Presence Medical Group Hematology Oncology, Skokie, Illinois 60077, United States; Active, not recruiting

Siu School Of Medicine, Springfield, Illinois 62794, United States; Active, not recruiting

Franciscan Physician Network Oncology And Hematology Specialists, Indianapolis, Indiana 46237, United States; Active, not recruiting

Local Institution, New Albany, Indiana 47150, United States; Not yet recruiting
Site 005

Local Institution, Guadalajara, Jalisco 44280, Mexico; Active, not recruiting

Local Institution, Hwasun-eup, Hwasun-gun, Jeonnam 519-763, Korea, Republic of; Active, not recruiting

Local Institution, Nangjing, Jiangsu 210002, China; Active, not recruiting

Local Institution, Soochow, Jiangsu 215006, China; Active, not recruiting

Local Institution, Changchun, Jilin 130012, China; Active, not recruiting

Local Institution, Yokohama-Shi, Kanagawa 2360051, Japan; Active, not recruiting

Local Institution, Yokohama-shi, Kanagawa 2408555, Japan; Active, not recruiting

Cancer Center Of Kansas, Wichita, Kansas 67214, United States; Active, not recruiting

Ashland Bellefonte Cancer Center, Ashland, Kentucky 41101, United States; Active, not recruiting

University Of Kentucky, Lexington, Kentucky 40536, United States; Active, not recruiting

Montgomery Cancer Center, Mount Sterling, Kentucky 40353, United States; Active, not recruiting

Local Institution, Baton Rouge, Louisiana 70809, United States; Not yet recruiting
Site 116

Local Institution, Withington, Manchester M20 4BX, United Kingdom; Active, not recruiting

St Joseph Mercy Hospital, Ypsilanti, Michigan 48197, United States; Active, not recruiting

Local Institution, Kansas City, Missouri 64111, United States; Not yet recruiting
Site 037

Local Institution, Natori-shi, Miyagi 9811293, Japan; Completed

Southeast Nebraska Hematology & Oncology Consultants, P.C., Lincoln, Nebraska 68510, United States; Active, not recruiting

Regional Cancer Care Associates, Llc/Cherry Hill Division, Cherry Hill, New Jersey 08003, United States; Active, not recruiting

Local Institution, Kogarah, New South Wales 2217, Australia; Active, not recruiting

Local Institution, Wollongong, New South Wales 2500, Australia; Active, not recruiting

Gabrail Cancer Center, Canton, Ohio 44718, United States; Active, not recruiting

Local Institution, Columbus, Ohio 43219, United States; Not yet recruiting
Site 043

Signal Point Clinical Research Center, Llc, Middletown, Ohio 45042, United States; Active, not recruiting

Local Institution, Oklahoma City, Oklahoma 73120, United States; Not yet recruiting
Site 034

Cancer Care Associates, Tulsa, Oklahoma 74104, United States; Active, not recruiting

Kaiser Permanente, Portland, Oregon 97227, United States; Active, not recruiting

Local Institution, Hirakata-shi, Osaka 5731191, Japan; Active, not recruiting

Local Institution, Curitiba, Parana 81520, Brazil; Active, not recruiting

Local Institution, Montreal, Quebec H2L 4M1, Canada; Active, not recruiting

Local Institution, Montreal, Quebec H2W 1S6, Canada; Active, not recruiting

Local Institution, Santiago, Region Metropolitana 8420383, Chile; Active, not recruiting

Local Institution, Rosario, Santa Fe S2000DSV, Argentina; Completed

Local Institution, Xi'an, Shaanxi 710038, China; Active, not recruiting

Local Institution, Xi'an, Shaanxi 710061, China; Active, not recruiting

Local Institution, Shanghai, Shanghai 200433, China; Active, not recruiting

Local Institution, Chengdu City, Sichuan 610041, China; Active, not recruiting

Local Institution, Bedford Park, South Australia 5042, Australia; Active, not recruiting

Associated In Oncology And Hematology, Chattanooga, Tennessee 37421, United States; Active, not recruiting

The Jones Clinic, Pc, Germantown, Tennessee 38138, United States; Active, not recruiting

Tennessee Cancer Specialists, Knoxville, Tennessee 37909, United States; Active, not recruiting

Henry-Joyce Cancer Center, Nashville, Tennessee 37232, United States; Active, not recruiting

Tennessee Oncology, Pllc, Nashville, Tennessee 37203, United States; Active, not recruiting

Huntsman Cancer Institute At The Univ. Of Utah, Salt Lake City, Utah 84112, United States; Active, not recruiting

Local Institution, Vina Del Mar, Valparaiso 2540364, Chile; Active, not recruiting

Local Institution, Fitzroy, Victoria 3065, Australia; Not yet recruiting
Site 045

Local Institution, Newport News, Virginia 23601, United States; Not yet recruiting
Site 028

Mary Babb Randolph Cancer Center, Morgantown, West Virginia 26506, United States; Active, not recruiting

Local Institution, Perth, Western Australia 6009, Australia; Active, not recruiting

Local Institution, Urumqi, Xinjiang 830011, China; Active, not recruiting

Local Institution, Ube-shi, Yamaguchi 7550241, Japan; Completed

Local Institution, Hangzhou City, Zhejiang 310009, China; Active, not recruiting

Local Institution, Hangzhou, Zhejiang 310016, China; Active, not recruiting

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: December 2011
Last updated: August 19, 2015

Page last updated: August 23, 2015

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