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: June 7, 2016
Last verified: June 2016
  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 (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy [ Time Frame: Randomization until date of death, up to March 2015, approximately 38 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Overall Survival in All Randomized Participants [ Time Frame: From randomization until date of death, up to March 2015, approximately 38 months ] [ Designated as safety issue: No ]
    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.

  • Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy [ Time Frame: From randomization until disease progression, up to March 2015, approximately 38 months ] [ Designated as safety issue: No ]
    Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.


Enrollment: 1414
Study Start Date: December 2011
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Sutter Auburn Faith Hospital
Auburn, California, United States, 95602
Ucsd Moores Cancer Center
La Jolla, California, United States, 92093
United States, Colorado
University Of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
Cancer Specialists, Llc
Jacksonville, Florida, United States, 32256
Cancer Care Of North Florida, Pa
Lake City, Florida, United States, 32024
Florida Cancer Specialists
St. Petersburg, Florida, United States, 33705
United States, Georgia
Medical Oncology, Llc
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, New Jersey, United States, 08003
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States, 45242
University Hospitals Of Cleveland
Cleveland, Ohio, United States, 44106
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
Local Institution
Portland, Oregon, United States, 97213
Kaiser Permanente
Portland, Oregon, United States, 97227
United States, Tennessee
Tennessee Oncology, Pllc
Chattanooga, Tennessee, United States, 37404
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
Local Institution
Knoxville, Tennessee, United States, 37916
Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
Henry-Joyce Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
University Of Texas, M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Local Institution
Lubbock, Texas, United States, 79410
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
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
Local Institution
Richmond, Virginia, United States, 23298
United States, West Virginia
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States, 26506
Argentina
Local Institution
Berazategui, Buenos Aires, Argentina, B1884BBF
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Buenos Aires, Argentina, B1704ESN
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Buenos Aires, Argentina, C1280AEB
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Ciudad Autonoma de Buenos Aires, Argentina, C1226ANZ
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Provincia de Sante Fe, Argentina, S2000DSV
Australia, New South Wales
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Kogarah, New South Wales, Australia, 2217
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Wollongong, New South Wales, Australia, 2500
Australia, Queensland
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Chermside, Queensland, Australia, 4032
Australia, South Australia
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Bedford Park, South Australia, Australia, 5042
Australia, Victoria
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Fitzroy, Victoria, Australia, 3065
Australia, Western Australia
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Perth, Western Australia, Australia, 6009
Austria
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Salzburg, Austria, 5020
Belgium
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Edegem, Belgium, 2650
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Leuven, Belgium, 3000
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Yvoir, Belgium, 5530
Brazil
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Centro, Joinville/SC, Brazil, CEP 89201-260
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Curitiba, Parana, Brazil, 81520
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Passo Fundo, Rio Grande do Sul, Brazil, 99010
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Porto Alegre, RS, Brazil, 90050
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Sao Paulo, Brazil, 01246
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SP, Brazil, 12245
Canada, Quebec
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Montreal, Quebec, Canada, H2L 4M1
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Montreal, Quebec, Canada, H2W 1S6
Chile
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Vitacura, Santiago, Chile, 7630370
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Vina Del Mar, Valparaiso, Chile, Region de Valparaiso, 2540364
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Santiago, Chile, 8360160
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Santiago, Chile, 8420383
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Valparaiso, Chile, 2341391
China, Guangdong
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Guangzhou, Guangdong, China, 510060
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Guangzhou, Guangdong, China, 510080
China, Heilongjiang
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Harbin, Heilongjiang, China, 150084
China, Hubei
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Wuhan, Hubei, China, 430023
China, Jiangsu
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Nangjing, Jiangsu, China, 210002
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Soochow, Jiangsu, China, 215006
China, Jilin
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Changchun, Jilin, China, 130012
China, Shaanxi
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Xi'an, Shaanxi, China, 710038
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Xi'an, Shaanxi, China, 710061
China, Sichuan
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Chengdu City, Sichuan, China, 610041
China, Xinjiang
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Urumqi, Xinjiang, China, 830011
China, Zhejiang
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Hangzhou City, Zhejiang, China, 310009
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Hangzhou City, Zhejiang, China
China
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Beijing, China, 100032
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Beijing, China, 100071
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Beijing, China, 100142
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Beijing, China, 100853
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Shanghai, China, 200030
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Shanghai, China, 200433
Colombia
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Cordoba, Colombia
Czech Republic
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Ostrava - Poruba, Czech Republic, 70852
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Praha 2, Czech Republic, 128 08
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Praha 8, Czech Republic, 180 81
France
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Caen, France, 14076
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Rennes Cedex 9, France, 35033
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Toulouse Cedex 9, France, 31059
Germany
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Bochum, Germany, 44791
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Gauting, Germany, 82131
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Grosshansdorf, Germany, 22927
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Heidelberg, Germany, 69126
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Mannheim, Germany, 68167
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Munchen, Germany, 81925
Hong Kong
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Hong Kong, Hong Kong
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Kowloon, Hong Kong
Hungary
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Budapest, Hungary, 1121
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Budapest, Hungary, 1125
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Budapest, Hungary, H-1121
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Farkasgyepu, Hungary, 8582
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Matrahaza, Hungary, 3233
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Pecs, Hungary, H-7623
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Sopron, Hungary, 9400
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Szekesfehervar, Hungary, 8000
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Szolnok, Hungary, H-5000
Ireland
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Dublin, Ireland, 4
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Dublin, Ireland, 8
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Limerick, Ireland
Israel
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Kfar-saba, Israel, 44281
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Zerifin, Israel, 70300
Italy
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Livorno, Italy, 57100
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Lucca, Italy, 55100
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Meldola (FC), Italy, 47014
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Siena, Italy, 53100
Japan
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Nagoya-shi, Aichi, Japan, 4600001
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Nagoya, Aichi, Japan, 4648681
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Kashiwa, Chiba, Japan, 2778577
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Matsuyama-shi, Ehime, Japan, 7910280
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Sapporo, Hokkaido, Japan, 0608648
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Yokohama-Shi, Kanagawa, Japan, 2360051
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Yokohama-shi, Kanagawa, Japan, 2408555
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Natori, Miyagi, Japan, 981-1293
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Kurashiki-shi, Okayama, Japan, 710-8602
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Hirakata-shi, Osaka, Japan, 5731191
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Takatsuki, Osaka, Japan, 5698686
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Sunto-gun, Shizuoka, Japan, 4118777
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Chuo-ku, Tokyo, Japan, 104-0045
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Ube-shi, Yamaguchi, Japan, 7550241
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Akashi, Hyogo, Japan, 673-8558
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Fukoka, Japan, 811-1395
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Fukuoka, Japan, 8128582
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Sendai, Miyagi, Japan, 980-0873
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Tokyo, Japan, 135-8550
Korea, Republic of
Local Institution
Goyang-si, Gyeonggji-do, Korea, Republic of, 410-769
Local Institution
Hwasun-eup, Hwasun-gun, Jeonnam, Korea, Republic of, 519-763
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Busan, Korea, Republic of, 602-739
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Seoul, Korea, Republic of, 120-752
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Seoul, Korea, Republic of, 135-710
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Seoul, Korea, Republic of, 136-705
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Seoul, Korea, Republic of, 138-736
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Suwon, Korea, Republic of, 443-721
Mexico
Local Institution
Leon, Guanajato, Guanajuato, Mexico, 37000
Local Institution
Guadalajara, Jalisco, Mexico, 44280
Local Institution
San Luis Potosi, S.L.P., Mexico, C.P. 78218
Netherlands
Local Institution
's-Hertogenbosch, Netherlands, 5223 GZ
Local Institution
Eindhoven, Netherlands, 5623 EJ
Peru
Local Institution
Cercado, Peru
Local Institution
Lima, Peru, 027
Local Institution
Lima, Peru, Lima 41
Poland
Local Institution
Karkow, Poland, 31-202
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Otwock, Poland, 05-400
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Torun, Poland, 87-100
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Warszawa, Poland, 02-781
Portugal
Local Institution
Coimbra, Portugal, 3041853
Romania
Local Institution
Cluj Napoca, Judetul Cluj, Romania, 400058
Local Institution
Craiova, Judetul Dolj, Romania, 200385
Local Institution
Bucuresti, Romania
Local Institution
Cluj Napoca, Romania, 400015
Russian Federation
Local Institution
Chelyabinsk, Russian Federation, 454087
Local Institution
Krasnodar, Russian Federation, 350040
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Kursk, Russian Federation, 305035
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Moscow, Russian Federation, 115478
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Pyatigorsk, Russian Federation, 35702
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Saint Petersburg, Russian Federation, 197022
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Saint Petersburg, Russian Federation, 197758
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St. Petersburg, Russian Federation, 194291
Local Institution
St. Petersburg, Russian Federation, 198255
South Africa
Local Institution
Port Elizabeth, Eastern Cape, South Africa, 6045
Local Institution
Pretoria, South Africa, 0002
Spain
Local Institution
A Coruna, Galicia, Spain, 15006
Local Institution
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
Sweden
Local Institution
Stockholm, Sweden, 17176
Local Institution
Uppsala, Sweden, 75185
Switzerland
Local Institution
Basel, Switzerland, 4031
Taiwan
Local Institution
Changhua City, Taiwan, R.O.C.
Local Institution
Taichung, Taiwan, 404
Thailand
Local Institution
Chiang Mai, Thailand, 50200
United Kingdom
Local Institution
Preston, Lancashire, United Kingdom, PR2 9HT
Local Institution
Withington, Manchester, United Kingdom, M20 4BX
Local Institution
London, United Kingdom, N18 1QX
Local Institution
London, United Kingdom, SW3 6JJ
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:
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
Results First Received: March 7, 2016
Last Updated: June 7, 2016
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:
Small Cell Lung Carcinoma
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Etoposide phosphate
Cisplatin
Carboplatin
Etoposide
Antibodies, Monoclonal
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2016