Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01450761




Trial ID
NCT01450761
Ethics application status
Date submitted
10/10/2011
Date registered
11/10/2011
Date last updated
14/06/2017

Titles & IDs
Public title
Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone
Scientific 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)
Secondary ID [1] 0 0
2011-000850-48
Secondary ID [2] 0 0
CA184-156
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Ipilimumab
Other interventions - Placebo matching Ipilimumab
Treatment: Drugs - Etoposide
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin

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

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


Other interventions: Ipilimumab


Other interventions: Placebo matching Ipilimumab


Treatment: Drugs: Etoposide


Treatment: Drugs: Cisplatin


Treatment: Drugs: Carboplatin


Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Randomization until date of death, up to March 2015, approximately 38 months
Secondary outcome [1] 0 0
Overall Survival in All Randomized Participants - 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.
Timepoint [1] 0 0
From randomization until date of death, up to March 2015, approximately 38 months
Secondary outcome [2] 0 0
Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy - 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.
Timepoint [2] 0 0
From randomization until disease progression, up to March 2015, approximately 38 months

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.



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

- Eastern Cooperative Oncology Group (ECOG) of 0 or 1
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior systemic therapy for lung cancer

- Symptomatic Central Nervous System (CNS) metastases

- History of autoimmune disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Kogarah
Recruitment hospital [2] 0 0
Local Institution - Wollongong
Recruitment hospital [3] 0 0
Local Institution - Chermside
Recruitment hospital [4] 0 0
Local Institution - Bedford Park
Recruitment hospital [5] 0 0
Local Institution - Fitzroy
Recruitment hospital [6] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
West Virginia
Country [23] 0 0
Argentina
State/province [23] 0 0
Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Ciudad Autonoma de Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Provincia de Sante Fe
Country [26] 0 0
Austria
State/province [26] 0 0
Salzburg
Country [27] 0 0
Belgium
State/province [27] 0 0
Edegem
Country [28] 0 0
Belgium
State/province [28] 0 0
Leuven
Country [29] 0 0
Belgium
State/province [29] 0 0
Yvoir
Country [30] 0 0
Brazil
State/province [30] 0 0
Joinville/SC
Country [31] 0 0
Brazil
State/province [31] 0 0
Parana
Country [32] 0 0
Brazil
State/province [32] 0 0
Rio Grande do Sul
Country [33] 0 0
Brazil
State/province [33] 0 0
Porto Alegre, RS
Country [34] 0 0
Brazil
State/province [34] 0 0
Sao Paulo
Country [35] 0 0
Brazil
State/province [35] 0 0
SP
Country [36] 0 0
Canada
State/province [36] 0 0
Quebec
Country [37] 0 0
Chile
State/province [37] 0 0
Santiago
Country [38] 0 0
Chile
State/province [38] 0 0
Valparaiso
Country [39] 0 0
China
State/province [39] 0 0
Guangdong
Country [40] 0 0
China
State/province [40] 0 0
Heilongjiang
Country [41] 0 0
China
State/province [41] 0 0
Hubei
Country [42] 0 0
China
State/province [42] 0 0
Jiangsu
Country [43] 0 0
China
State/province [43] 0 0
Jilin
Country [44] 0 0
China
State/province [44] 0 0
Shaanxi
Country [45] 0 0
China
State/province [45] 0 0
Sichuan
Country [46] 0 0
China
State/province [46] 0 0
Xinjiang
Country [47] 0 0
China
State/province [47] 0 0
Zhejiang
Country [48] 0 0
China
State/province [48] 0 0
Beijing
Country [49] 0 0
China
State/province [49] 0 0
Shanghai
Country [50] 0 0
Colombia
State/province [50] 0 0
Cordoba
Country [51] 0 0
Czechia
State/province [51] 0 0
Ostrava - Poruba
Country [52] 0 0
Czechia
State/province [52] 0 0
Praha 2
Country [53] 0 0
Czechia
State/province [53] 0 0
Praha 8
Country [54] 0 0
France
State/province [54] 0 0
Caen
Country [55] 0 0
France
State/province [55] 0 0
Rennes Cedex 9
Country [56] 0 0
France
State/province [56] 0 0
Toulouse Cedex 9
Country [57] 0 0
Germany
State/province [57] 0 0
Bochum
Country [58] 0 0
Germany
State/province [58] 0 0
Gauting
Country [59] 0 0
Germany
State/province [59] 0 0
Grosshansdorf
Country [60] 0 0
Germany
State/province [60] 0 0
Heidelberg
Country [61] 0 0
Germany
State/province [61] 0 0
Mannheim
Country [62] 0 0
Germany
State/province [62] 0 0
Munchen
Country [63] 0 0
Hong Kong
State/province [63] 0 0
Hong Kong
Country [64] 0 0
Hong Kong
State/province [64] 0 0
Kowloon
Country [65] 0 0
Hungary
State/province [65] 0 0
Budapest
Country [66] 0 0
Hungary
State/province [66] 0 0
Farkasgyepu
Country [67] 0 0
Hungary
State/province [67] 0 0
Matrahaza
Country [68] 0 0
Hungary
State/province [68] 0 0
Pecs
Country [69] 0 0
Hungary
State/province [69] 0 0
Sopron
Country [70] 0 0
Hungary
State/province [70] 0 0
Szekesfehervar
Country [71] 0 0
Hungary
State/province [71] 0 0
Szolnok
Country [72] 0 0
Ireland
State/province [72] 0 0
Dublin
Country [73] 0 0
Ireland
State/province [73] 0 0
Limerick
Country [74] 0 0
Israel
State/province [74] 0 0
Kfar-saba
Country [75] 0 0
Israel
State/province [75] 0 0
Zerifin
Country [76] 0 0
Italy
State/province [76] 0 0
Livorno
Country [77] 0 0
Italy
State/province [77] 0 0
Lucca
Country [78] 0 0
Italy
State/province [78] 0 0
Meldola (FC)
Country [79] 0 0
Italy
State/province [79] 0 0
Siena
Country [80] 0 0
Japan
State/province [80] 0 0
Aichi
Country [81] 0 0
Japan
State/province [81] 0 0
Chiba
Country [82] 0 0
Japan
State/province [82] 0 0
Ehime
Country [83] 0 0
Japan
State/province [83] 0 0
Hokkaido
Country [84] 0 0
Japan
State/province [84] 0 0
Kanagawa
Country [85] 0 0
Japan
State/province [85] 0 0
Miyagi
Country [86] 0 0
Japan
State/province [86] 0 0
Okayama
Country [87] 0 0
Japan
State/province [87] 0 0
Osaka
Country [88] 0 0
Japan
State/province [88] 0 0
Shizuoka
Country [89] 0 0
Japan
State/province [89] 0 0
Tokyo
Country [90] 0 0
Japan
State/province [90] 0 0
Yamaguchi
Country [91] 0 0
Japan
State/province [91] 0 0
Akashi, Hyogo
Country [92] 0 0
Japan
State/province [92] 0 0
Fukoka
Country [93] 0 0
Japan
State/province [93] 0 0
Fukuoka
Country [94] 0 0
Japan
State/province [94] 0 0
Sendai, Miyagi
Country [95] 0 0
Korea, Republic of
State/province [95] 0 0
Gyeonggji-do
Country [96] 0 0
Korea, Republic of
State/province [96] 0 0
Jeonnam
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Busan
Country [98] 0 0
Korea, Republic of
State/province [98] 0 0
Seoul
Country [99] 0 0
Korea, Republic of
State/province [99] 0 0
Suwon
Country [100] 0 0
Mexico
State/province [100] 0 0
Guanajuato
Country [101] 0 0
Mexico
State/province [101] 0 0
Jalisco
Country [102] 0 0
Mexico
State/province [102] 0 0
San Luis Potosi, S.L.P.
Country [103] 0 0
Netherlands
State/province [103] 0 0
's-Hertogenbosch
Country [104] 0 0
Netherlands
State/province [104] 0 0
Eindhoven
Country [105] 0 0
Peru
State/province [105] 0 0
Cercado
Country [106] 0 0
Peru
State/province [106] 0 0
Lima
Country [107] 0 0
Poland
State/province [107] 0 0
Karkow
Country [108] 0 0
Poland
State/province [108] 0 0
Otwock
Country [109] 0 0
Poland
State/province [109] 0 0
Torun
Country [110] 0 0
Poland
State/province [110] 0 0
Warszawa
Country [111] 0 0
Portugal
State/province [111] 0 0
Coimbra
Country [112] 0 0
Romania
State/province [112] 0 0
Judetul Cluj
Country [113] 0 0
Romania
State/province [113] 0 0
Judetul Dolj
Country [114] 0 0
Romania
State/province [114] 0 0
Bucuresti
Country [115] 0 0
Romania
State/province [115] 0 0
Cluj Napoca
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Chelyabinsk
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Krasnodar
Country [118] 0 0
Russian Federation
State/province [118] 0 0
Kursk
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Moscow
Country [120] 0 0
Russian Federation
State/province [120] 0 0
Pyatigorsk
Country [121] 0 0
Russian Federation
State/province [121] 0 0
Saint Petersburg
Country [122] 0 0
Russian Federation
State/province [122] 0 0
St. Petersburg
Country [123] 0 0
South Africa
State/province [123] 0 0
Eastern Cape
Country [124] 0 0
South Africa
State/province [124] 0 0
Pretoria
Country [125] 0 0
Spain
State/province [125] 0 0
Galicia
Country [126] 0 0
Spain
State/province [126] 0 0
Barcelona
Country [127] 0 0
Spain
State/province [127] 0 0
Benidorm-alicante
Country [128] 0 0
Spain
State/province [128] 0 0
Lleida
Country [129] 0 0
Spain
State/province [129] 0 0
Malaga
Country [130] 0 0
Sweden
State/province [130] 0 0
Stockholm
Country [131] 0 0
Sweden
State/province [131] 0 0
Uppsala
Country [132] 0 0
Switzerland
State/province [132] 0 0
Basel
Country [133] 0 0
Taiwan
State/province [133] 0 0
Changhua City
Country [134] 0 0
Taiwan
State/province [134] 0 0
Taichung
Country [135] 0 0
Thailand
State/province [135] 0 0
Chiang Mai
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Lancashire
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Manchester
Country [138] 0 0
United Kingdom
State/province [138] 0 0
London
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT01450761
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries