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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01450761
First received: October 10, 2011
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Small Cell Lung Carcinoma
Biological: Ipilimumab
Biological: Placebo matching Ipilimumab
Drug: Etoposide
Drug: Cisplatin
Drug: Carboplatin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall Survival among subjects who receive at least one dose of blinded study therapy [ Time Frame: Approximately 41 months after the 1st subject is randomized ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival in all Randomized Subjects [ Time Frame: Approximately 41 months after the 1st subject is randomized ] [ Designated as safety issue: No ]
  • Progression Free Survival per mWHO in subjects who have received at least one dose of blinded study therapy [ Time Frame: Approximately 41 months after the 1st subject is randomized ] [ Designated as safety issue: No ]

Estimated Enrollment: 1125
Study Start Date: December 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab+Etoposide+Cisplatin/Carboplatin

Ipilimumab: 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

Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016
Drug: Etoposide
Other Names:
  • Etopophos
  • Neoposid
  • Eposin
Drug: Cisplatin
Other Name: Platinol
Drug: Carboplatin
Other Name: Paraplatin
Placebo Comparator: Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin

Placebo 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

Biological: Placebo matching Ipilimumab Drug: Etoposide
Other Names:
  • Etopophos
  • Neoposid
  • Eposin
Drug: Cisplatin
Other Name: Platinol
Drug: Carboplatin
Other Name: Paraplatin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450761

  Hide Study Locations
Locations
United States, Arkansas
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
United States, California
Ucsd Moores Cancer Center
La Jolla, California, United States, 92093
Sutter Cancer Center
Sacramento, California, United States, 95816
United States, Florida
Cancer Specialists, Llc
Jacksonville, Florida, United States, 32256
Cancer Care Of North Florida, Pa
Lake City, Florida, United States, 32024
United States, Georgia
Medical Oncology Associates Of Augusta,Pc
Augusta, Georgia, United States, 30901
United States, Illinois
Quincy Medical Group
Quincy, Illinois, United States, 62301
Presence Medical Group Hematology Oncology
Skokie, Illinois, United States, 60077
Siu School Of Medicine
Springfield, Illinois, United States, 62794
United States, Indiana
Franciscan Physician Network Oncology And Hematology Specialists
Indianapolis, Indiana, United States, 46237
Local Institution
New Albany, Indiana, United States, 47150
United States, Kansas
Cancer Center Of Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
Ashland Bellefonte Cancer Center
Ashland, Kentucky, United States, 41101
University Of Kentucky
Lexington, Kentucky, United States, 40536
Montgomery Cancer Center
Mount Sterling, Kentucky, United States, 40353
United States, Louisiana
Local Institution
Baton Rouge, Louisiana, United States, 70809
United States, Michigan
St Joseph Mercy Hospital
Ypsilanti, Michigan, United States, 48197
United States, Missouri
Local Institution
Kansas City, Missouri, United States, 64111
United States, Nebraska
Southeast Nebraska Hematology & Oncology Consultants, P.C.
Lincoln, Nebraska, United States, 68510
United States, New Jersey
Regional Cancer Care Associates, Llc/Cherry Hill Division
Cherry Hill, New Jersey, United States, 08003
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Local Institution
Columbus, Ohio, United States, 43219
Signal Point Clinical Research Center, Llc
Middletown, Ohio, United States, 45042
United States, Oklahoma
Local Institution
Oklahoma City, Oklahoma, United States, 73120
Cancer Care Associates
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Kaiser Permanente
Portland, Oregon, United States, 97227
United States, Tennessee
Associated In Oncology And Hematology
Chattanooga, Tennessee, United States, 37421
The Jones Clinic, Pc
Germantown, Tennessee, United States, 38138
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37909
Henry-Joyce Cancer Center
Nashville, Tennessee, United States, 37232
Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
United States, Utah
Huntsman Cancer Institute At The Univ. Of Utah
Salt Lake City, Utah, United States, 84112
United States, Virginia
Local Institution
Newport News, Virginia, United States, 23601
United States, West Virginia
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States, 26506
Argentina
Local Institution
Rosario, Santa Fe, Argentina, S2000DSV
Local Institution
Berazategui, Argentina, 1884
Local Institution
Caba, Argentina, 1426
Local Institution
Ciudad Autonoma de Buenos, Argentina, C1280AEB
Australia, New South Wales
Local Institution
Kogarah, New South Wales, Australia, 2217
Local Institution
Wollongong, New South Wales, Australia, 2500
Australia, South Australia
Local Institution
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Local Institution
Fitzroy, Victoria, Australia, 3065
Australia, Western Australia
Local Institution
Perth, Western Australia, Australia, 6009
Austria
Local Institution
Salzburg, Austria, 5020
Belgium
Local Institution
Leuven, Belgium, 3000
Local Institution
Yvoir, Belgium, 5530
Brazil
Local Institution
Curitiba, Parana, Brazil, 81520
Local Institution
Sao Paulo, Brazil, 01246
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H2W 1S6
Local Institution
Montreal, Quebec, Canada, H2L 4M1
Chile
Local Institution
Santiago, Region Metropolitana, Chile, 8420383
Local Institution
Vina Del Mar, Valparaiso, Chile, 2540364
Local Institution
Valparaiso, Chile, 2363068
China, Beijing
Local Institution
Beijing, Beijing, China, 100142
China, Guangdong
Local Institution
Guangzhou, Guangdong, China, 510060
Local Institution
Guangzhou, Guangdong, China, 510080
China, Heilongjiang
Local Institution
Harbin, Heilongjiang, China, 150084
China, Hubei
Local Institution
Wuhan, Hubei, China, 430023
China, Jiangsu
Local Institution
Nangjing, Jiangsu, China, 210002
Local Institution
Soochow, Jiangsu, China, 215006
China, Jilin
Local Institution
Changchun, Jilin, China, 130012
China, Shaanxi
Local Institution
Xi'an, Shaanxi, China, 710038
Local Institution
Xi'an, Shaanxi, China, 710061
China, Shanghai
Local Institution
Shanghai, Shanghai, China, 200433
China, Sichuan
Local Institution
Chengdu City, Sichuan, China, 610041
China, Xinjiang
Local Institution
Urumqi, Xinjiang, China, 830011
China, Zhejiang
Local Institution
Hangzhou, Zhejiang, China, 310016
Local Institution
Hangzhou City, Zhejiang, China, 310009
China
Local Institution
Beijing, China, 100071
Local Institution
Beijing, China, 100853
Local Institution
Beijing, China, 100032
Local Institution
Shanghai, China, 200030
Colombia
Local Institution
Monteria, Cordoba, Colombia
Local Institution
Bogota, Cundinamarca, Colombia
Czech Republic
Local Institution
Ostrava - Poruba, Czech Republic, 70852
Local Institution
Prague, Czech Republic, 128 08
Local Institution
Prague 8, Czech Republic, 180 81
France
Local Institution
Caen, France, 14076
Local Institution
Rennes Cedex 9, France, 35033
Local Institution
Toulouse Cedex 9, France, 31059
Germany
Local Institution
Bochum, Germany, 44791
Local Institution
Gauting, Germany, 82131
Local Institution
Grosshansdorf, Germany, 22927
Local Institution
Heidelberg, Germany, 69126
Local Institution
Mannheim, Germany, 68167
Local Institution
Munchen, Germany, 81925
Hong Kong
Local Institution
Hong Kong, Hong Kong
Local Institution
Kowloon, Hong Kong
Hungary
Local Institution
Budapest, Hungary, 1125
Local Institution
Farkasgyepu, Hungary, 8582
Local Institution
Matrahaza, Hungary, 3233
Local Institution
Sopron, Hungary, 9400
Local Institution
Szekesfehervar, Hungary, 8000
Local Institution
Szolnok, Hungary, H-5000
Ireland
Local Institution
Dublin, Ireland, 8
Local Institution
Dublin, Ireland, 4
Israel
Local Institution
Kfar-saba, Israel, 44281
Local Institution
Zerifin, Israel, 70300
Italy
Local Institution
Lucca, Italy, 55100
Local Institution
Siena, Italy, 53100
Japan
Local Institution
Nagoya-shi, Aichi, Japan, 4600001
Local Institution
Yokohama-Shi, Kanagawa, Japan, 2360051
Local Institution
Yokohama-shi, Kanagawa, Japan, 2408555
Local Institution
Natori-shi, Miyagi, Japan, 9811293
Local Institution
Hirakata-shi, Osaka, Japan, 5731191
Local Institution
Ube-shi, Yamaguchi, Japan, 7550241
Korea, Republic of
Local Institution
Seoul, Gangnam-gu, Korea, Republic of, 135-710
Local Institution
Goyang-si, Gyeonggji-do, Korea, Republic of, 410-769
Local Institution
Hwasun-eup, Hwasun-gun, Jeonnam, Korea, Republic of, 519-763
Local Institution
Busan, Korea, Republic of, 602-739
Local Institution
Seoul, Korea, Republic of, 120-752
Local Institution
Seoul, Korea, Republic of, 138-736
Local Institution
Seoul, Korea, Republic of, 136-705
Local Institution
Suwon, Korea, Republic of, 443-721
Mexico
Local Institution
Guadalajara, Jalisco, Mexico, 44280
Local Institution
San Luis Potosi, Mexico, 78419
Netherlands
Local Institution
Eindhoven, Netherlands, 5623 EJ
Peru
Local Institution
Lima, Peru, Lima 01
Poland
Local Institution
Krakow, Poland, 31202
Local Institution
Otwock, Poland, 05-400
Local Institution
Torun, Poland, 87-100
Local Institution
Warszawa, Poland, 02-781
Portugal
Local Institution
Coimbra, Portugal, 3041853
Romania
Local Institution
Cluj Napoca, Romania, 400058
Local Institution
Craiova, Romania, 200385
Russian Federation
Local Institution
Chelyabinsk, Russian Federation, 454087
Local Institution
Krasnodar, Russian Federation, 350040
Local Institution
Moscow, Russian Federation, 115478
Local Institution
Pyatigorsk, Russian Federation, 35702
Local Institution
St. Petersburg, Russian Federation, 194291
Local Institution
St. Petersburg, Russian Federation, 198255
South Africa
Local Institution
Port Elizabeth, Eastern Cape, South Africa, 6045
Spain
Local Institution
Malaga, Andalucia, Spain, 29010
Local Institution
A Coruna, Galicia, Spain, 15006
Local Institution
Barcelona, Spain, 08035
Local Institution
Benidorm-alicante, Spain, 03501
Local Institution
Lleida, Spain, 25198
Local Institution
Malaga, Spain, 29010
Sweden
Local Institution
Stockholm, Sweden, 17176
Local Institution
Uppsala, Sweden, 75185
Switzerland
Local Institution
Basel, Switzerland, 4031
Taiwan
Local Institution
Changhua, Taiwan, 500
Local Institution
Taichung City, Taiwan, 40447
Thailand
Local Institution
Chiang Mai, Thailand, 50200
United Kingdom
Local Institution
Withington, Manchester, United Kingdom, M20 4BX
Local Institution
London, United Kingdom, SW3 6JJ
Local Institution
London, United Kingdom, N181QX
Local Institution
Preston, United Kingdom, PR2 9HT
Local Institution
Truro, United Kingdom, TR1 3LJ
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01450761     History of Changes
Other Study ID Numbers: CA184-156, 2011-000850-48
Study First Received: October 10, 2011
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration
Hong Kong: Department of Health
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Thailand: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: National Institute of Medicines
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Austria: Federal Office for Safety in Health Care
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Federal Office of Public Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
South Africa: Medicines Control Council
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Chile: CONEP
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Peru: Instituto Nacional de Salud
Mexico: Federal Commission for Sanitary Risks Protection
Denmark: Data inspectorate, Directorate for Health and Social Affairs
Finland: Finnish Medicines Agency
Norway: Directorate of Health
Sweden: Medical Products Agency
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antibodies, Monoclonal
Carboplatin
Cisplatin
Etoposide
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 24, 2014