Clinical trial NCT01450761: Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Small Cell Lung Carcinoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-10-12
Enrollment: 1351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy
timeFrame: Randomization until date of death, up to March 2015, approximately 38 months
Secondary outcomes:
measure: Overall Survival in All Randomized Participants
timeFrame: From randomization until date of death, up to March 2015, approximately 38 months
measure: Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy
timeFrame: From randomization until disease progression, up to March 2015, approximately 38 months
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Auburn
country: United States
facility: Sutter Medical Center
state: California
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: Aurora
country: United States
facility: University Of Colorado Cancer Center
state: Colorado
city: Fort Myers
country: United States
facility: Florida Cancer Specialists S.
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists, LLC
state: Florida
city: Lake City
country: United States
facility: Lake City Cancer Care
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Augusta
country: United States
facility: Medical Oncology, LLC
state: Georgia
city: Quincy
country: United States
facility: Quincy Medical Group
state: Illinois
city: Skokie
country: United States
facility: Presence Medical Group Hematology Oncology
state: Illinois
city: Springfield
country: United States
facility: SIU School Of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: St. Francis Medical Group Oncology And Hematology Specialist
state: Indiana
city: Wichita
country: United States
facility: Cancer Center Of Kansas
state: Kansas
city: Ashland
country: United States
facility: Ashland Bellefonte Cancer Center
state: Kentucky
city: Lexington
country: United States
facility: University Of Kentucky
state: Kentucky
city: Mount Sterling
country: United States
facility: Montgomery Cancer Center
state: Kentucky
city: Ypsilanti
country: United States
facility: St Joseph Mercy Hospital
state: Michigan
city: Kansas City
country: United States
facility: St. Luke'S Cancer Institute
state: Missouri
city: Lincoln
country: United States
facility: Southeast Nebraska Hematology & Oncology Consultants, P.C.
state: Nebraska
city: Cherry Hill
country: United States
facility: Regional Cancer Care Associates, LLC/Cherry Hill Division
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Incorporated
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Middletown
country: United States
facility: Signal Point Clinical Research Center, Llc
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC
state: Oklahoma
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente
state: Oregon
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology Associates
state: Tennessee
city: Chattanooga
country: United States
facility: Associated in Oncology and Hematology
state: Tennessee
city: Germantown
country: United States
facility: The Jones Clinic, PC
state: Tennessee
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Henry-Joyce Cancer Center
state: Tennessee
city: Houston
country: United States
facility: University Of Texas, M. D. Anderson Cancer Center
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research And Treatment Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Hospital
state: Utah
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Morgantown
country: United States
facility: Mary Babb Randolph Cancer Center
state: West Virginia
city: Berazategui
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Local Institution
city: Provincia De Sante Fe
country: Argentina
facility: Local Institution
city: Kogarah
country: Australia
facility: Local Institution
state: New South Wales
city: Wollongong
country: Australia
facility: Local Institution
state: New South Wales
city: Chermside
country: Australia
facility: Local Institution
state: Queensland
city: Bedford Park
country: Australia
facility: Local Institution
state: South Australia
city: Fitzroy
country: Australia
facility: Local Institution
state: Victoria
city: Wodonga
country: Australia
facility: Local Institution
state: Victoria
city: Perth
country: Australia
facility: Local Institution
state: Western Australia
city: Linz
country: Austria
facility: Local Institution
city: Salzburg
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Brussels
country: Belgium
facility: Local Institution
city: Edegem
country: Belgium
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: Sint Niklaas
country: Belgium
facility: Local Institution
city: Yvoir
country: Belgium
facility: Local Institution
city: Passo Fundo, RS
country: Brazil
facility: Local Institution
city: Sao Paulo/SP
country: Brazil
facility: Local Institution
city: SP
country: Brazil
facility: Local Institution
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Vina Del Mar
country: Chile
facility: Local Institution
state: Valparaiso
city: Santiago
country: Chile
facility: Local Institution
city: Santiago
country: Chile
facility: Local Institution
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Harbin
country: China
facility: Local Institution
state: Heilongjiang
city: Wuhan
country: China
facility: Local Institution
state: Hubei
city: Nangjing
country: China
facility: Local Institution
state: Jiangsu
city: Soochow
country: China
facility: Local Institution
state: Jiangsu
city: Changchun
country: China
facility: Local Institution
state: Jilin
city: Xi'an
country: China
facility: Local Institution
state: Shaanxi
city: Xi'an
country: China
facility: Local Institution
state: Shaanxi
city: Chengdu City
country: China
facility: Local Institution
state: Sichuan
city: Urumqi
country: China
facility: Local Institution
state: Xinjiang
city: Hangzhou City
country: China
facility: Local Institution
state: Zhejiang
city: Hangzhou City
country: China
facility: Local Institution
state: Zhejiang
city: Beijing
country: China
facility: Local Institution
city: Beijing
country: China
facility: Local Institution
city: Beijing
country: China
facility: Local Institution
city: Beijing
country: China
facility: Local Institution
city: Shanghai
country: China
facility: Local Institution
city: Shanghai
country: China
facility: Local Institution
city: Cordoba
country: Colombia
facility: Local Institution
city: Ostrava - Poruba
country: Czechia
facility: Local Institution
city: Praha 8
country: Czechia
facility: Local Institution
city: Caen
country: France
facility: Local Institution
city: Rennes Cedex 9
country: France
facility: Local Institution
city: Toulouse Cedex 9
country: France
facility: Local Institution
city: Vandoeuvre-les-nancy
country: France
facility: Local Institution
city: Bad Berka
country: Germany
facility: Local Institution
city: Bochum
country: Germany
facility: Local Institution
city: Dresden
country: Germany
facility: Local Institution
city: Erlangen
country: Germany
facility: Local Institution
city: Frankfurt am Main
country: Germany
facility: Local Institution
city: Gauting
country: Germany
facility: Local Institution
city: Grosshansdorf
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Kassel
country: Germany
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: Local Institution
city: Munchen
country: Germany
facility: Local Institution
city: Oldenburg
country: Germany
facility: Local Institution
city: Ulm
country: Germany
facility: Local Institution
city: Hong Kong
country: Hong Kong
facility: Local Institution
city: Kowloon
country: Hong Kong
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Farkasgyepu
country: Hungary
facility: Local Institution
city: Matrahaza
country: Hungary
facility: Local Institution
city: Pecs
country: Hungary
facility: Local Institution
city: Sopron
country: Hungary
facility: Local Institution
city: Szolnok
country: Hungary
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
city: Limerick
country: Ireland
facility: Local Institution
city: Beer Sheva
country: Israel
facility: Local Institution
city: Kfar-saba
country: Israel
facility: Local Institution
city: Petah-tikva
country: Israel
facility: Local Institution
city: Ramat-gan
country: Israel
facility: Local Institution
city: Zerifin
country: Israel
facility: Local Institution
city: Livorno
country: Italy
facility: Local Institution
city: Lucca
country: Italy
facility: Local Institution
city: Meldola (FC)
country: Italy
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Nagoya
country: Japan
facility: Local Institution
state: Aichi
city: Kashiwa
country: Japan
facility: Local Institution
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Local Institution
state: Ehime
city: Sapporo
country: Japan
facility: Local Institution
state: Hokkaido
city: Kanazawa-shi
country: Japan
facility: Local Institution
state: Ishikawa
city: Yokohama-Shi
country: Japan
facility: Local Institution
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Local Institution
state: Kanagawa
city: Natori
country: Japan
facility: Local Institution
state: Miyagi
city: Kurashiki-shi
country: Japan
facility: Local Institution
state: Okayama
city: Kurashiki-shi
country: Japan
facility: Local Institution
state: Okayama
city: Hirakata-shi
country: Japan
facility: Local Institution
state: Osaka
city: Takatsuki
country: Japan
facility: Local Institution
state: Osaka
city: Sunto-gun
country: Japan
facility: Local Institution
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Ube-shi
country: Japan
facility: Local Institution
state: Yamaguchi
city: Akashi, Hyogo
country: Japan
facility: Local Institution
city: Fukoka
country: Japan
facility: Local Institution
city: Fukuoka
country: Japan
facility: Local Institution
city: Osaka
country: Japan
facility: Local Institution
city: Oskaka
country: Japan
facility: Local Institution
city: Sapporo, Hokkaido
country: Japan
facility: Local Institution
city: Sendai, Miyagi
country: Japan
facility: Local Institution
city: Tokyo
country: Japan
facility: Local Institution
city: Goyang-si
country: Korea, Republic of
facility: Local Institution
state: Gyeonggji-do
city: Hwasun-eup, Hwasun-gun
country: Korea, Republic of
facility: Local Institution
state: Jeonnam
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Suwon
country: Korea, Republic of
facility: Local Institution
city: Suwon
country: Korea, Republic of
facility: Local Institution
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: San Luis Potosi, S.l.p.
country: Mexico
facility: Local Institution
city: 's-Hertogenbosch
country: Netherlands
facility: Local Institution
city: Breda
country: Netherlands
facility: Local Institution
city: Eindhoven
country: Netherlands
facility: Local Institution
city: Cercado
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Elblag
country: Poland
facility: Local Institution
city: Karkow
country: Poland
facility: Local Institution
city: Lublin
country: Poland
facility: Local Institution
city: Otwock
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Torun
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Coimbra
country: Portugal
facility: Local Institution
city: Lisboa
country: Portugal
facility: Local Institution
city: Cluj Napoca
country: Romania
facility: Local Institution
state: Judetul CLUJ
city: Craiova
country: Romania
facility: Local Institution
state: Judetul DOLJ
city: Bucuresti
country: Romania
facility: Local Institution
city: Cluj
country: Romania
facility: Local Institution
city: Chelyabinsk
country: Russian Federation
facility: Local Institution
city: Krasnodar
country: Russian Federation
facility: Local Institution
city: Kursk
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Pyatigorsk
country: Russian Federation
facility: Local Institution
city: Saint Petersburg
country: Russian Federation
facility: Local Institution
city: Saint Petersburg
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: Port Elizabeth
country: South Africa
facility: Local Institution
state: Eastern CAPE
city: Cape Town
country: South Africa
facility: Local Institution
state: Western CAPE
city: Pretoria
country: South Africa
facility: Local Institution
city: A Coruna
country: Spain
facility: Local Institution
state: Galicia
city: Barcelona
country: Spain
facility: Local Institution
city: Benidorm-alicante
country: Spain
facility: Local Institution
city: Castellon
country: Spain
facility: Local Institution
city: Lleida
country: Spain
facility: Local Institution
city: Majadahonda
country: Spain
facility: Local Institution
city: Malaga
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Linkoping
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Uppsala
country: Sweden
facility: Local Institution
city: Basel
country: Switzerland
facility: Local Institution
city: Winterthur
country: Switzerland
facility: Local Institution
city: Zuerich
country: Switzerland
facility: Local Institution
city: Changhua City
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taoyuan County
country: Taiwan
facility: Local Institution
city: Chiang Mai
country: Thailand
facility: Local Institution
city: Songkhla
country: Thailand
facility: Local Institution
city: Withington
country: United Kingdom
facility: Local Institution
state: Manchester
city: London
country: United Kingdom
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
city: Preston
country: United Kingdom
facility: Local Institution
city: Sutton
country: United Kingdom
facility: Local Institution
city: Truro
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Reck M, Luft A, Szczesna A, Havel L, Kim SW, Akerley W, Pietanza MC, Wu YL, Zielinski C, Thomas M, Felip E, Gold K, Horn L, Aerts J, Nakagawa K, Lorigan P, Pieters A, Kong Sanchez T, Fairchild J, Spigel D. Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol. 2016 Nov 1;34(31):3740-3748. doi: 10.1200/JCO.2016.67.6601.