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.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: October 10, 2011
Last updated: June 25, 2015
Last verified: June 2015

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: January 2012
Estimated Study Completion Date: March 2017
Primary Completion Date: March 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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

For more information regarding BMS clinical trial participation, please visit

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
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Please refer to this study by its identifier: NCT01450761

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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
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New Albany, Indiana, United States, 47150
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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
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Baton Rouge, Louisiana, United States, 70809
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St Joseph Mercy Hospital
Ypsilanti, Michigan, United States, 48197
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Kansas City, Missouri, United States, 64111
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Southeast Nebraska Hematology & Oncology Consultants, P.C.
Lincoln, Nebraska, United States, 68510
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Regional Cancer Care Associates, Llc/Cherry Hill Division
Cherry Hill, New Jersey, United States, 08003
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Gabrail Cancer Center
Canton, Ohio, United States, 44718
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Columbus, Ohio, United States, 43219
Signal Point Clinical Research Center, Llc
Middletown, Ohio, United States, 45042
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Oklahoma City, Oklahoma, United States, 73120
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Tulsa, Oklahoma, United States, 74104
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Kaiser Permanente
Portland, Oregon, United States, 97227
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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
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Huntsman Cancer Institute At The Univ. Of Utah
Salt Lake City, Utah, United States, 84112
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Newport News, Virginia, United States, 23601
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Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States, 26506
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Seoul, Gangnam-gu, Korea, Republic of, 135-710
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Hwasun-eup, Hwasun-gun, Jeonnam, Korea, Republic of, 519-763
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Port Elizabeth, Eastern Cape, South Africa, 6045
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Malaga, Andalucia, Spain, 29010
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A Coruna, Galicia, Spain, 15006
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Barcelona, Spain, 08035
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Benidorm-alicante, Spain, 03501
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Lleida, Spain, 25198
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Malaga, Spain, 29010
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Stockholm, Sweden, 17176
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Uppsala, Sweden, 75185
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Basel, Switzerland, 4031
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Changhua, Taiwan, 500
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Taichung City, Taiwan, 40447
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Chiang Mai, Thailand, 50200
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Withington, Manchester, United Kingdom, M20 4BX
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London, United Kingdom, N181QX
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London, United Kingdom, SW3 6JJ
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Preston, United Kingdom, PR2 9HT
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Truro, United Kingdom, TR1 3LJ
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb Identifier: NCT01450761     History of Changes
Other Study ID Numbers: CA184-156, 2011-000850-48
Study First Received: October 10, 2011
Last Updated: June 25, 2015
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 by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antibodies, Monoclonal
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 processed this record on July 01, 2015