Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone

Small Cell Lung Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450761
• Other study ID #: CA184-156
• Secondary ID: 2011-000850-48
• Status: Completed
• Phase: Phase 3
• Start date: December 13, 2011
• Est. completion date: May 17, 2017

Study information

• Verified date: July 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1351
• Est. completion date: May 17, 2017
• Est. primary completion date: March 19, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Small Cell Lung Carcinoma

Intervention

Biological:
• Ipilimumab

• Placebo matching Ipilimumab

Drug:
• Etoposide

• Cisplatin

• Carboplatin

Locations

Country	Name	City	State
Argentina	Local Institution	Berazategui	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Ciudad Autonoma de Buenos Aires
Argentina	Local Institution	Provincia De Sante Fe
Australia	Local Institution	Bedford Park	South Australia
Australia	Local Institution	Chermside	Queensland
Australia	Local Institution	Fitzroy	Victoria
Australia	Local Institution	Kogarah	New South Wales
Australia	Local Institution	Perth	Western Australia
Australia	Local Institution	Wodonga	Victoria
Australia	Local Institution	Wollongong	New South Wales
Austria	Local Institution	Linz
Austria	Local Institution	Salzburg
Austria	Local Institution	Wien
Austria	Local Institution	Wien
Belgium	Local Institution	Brussels
Belgium	Local Institution	Edegem
Belgium	Local Institution	Leuven
Belgium	Local Institution	Sint Niklaas
Belgium	Local Institution	Yvoir
Brazil	Local Institution	Passo Fundo, RS
Brazil	Local Institution	Sao Paulo/SP
Brazil	Local Institution	SP
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Montreal	Quebec
Chile	Local Institution	Santiago
Chile	Local Institution	Santiago
Chile	Local Institution	Vina Del Mar	Valparaiso
China	Local Institution	Beijing
China	Local Institution	Beijing
China	Local Institution	Beijing
China	Local Institution	Beijing
China	Local Institution	Changchun	Jilin
China	Local Institution	Chengdu City	Sichuan
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Hangzhou City	Zhejiang
China	Local Institution	Hangzhou City	Zhejiang
China	Local Institution	Harbin	Heilongjiang
China	Local Institution	Nangjing	Jiangsu
China	Local Institution	Shanghai
China	Local Institution	Shanghai
China	Local Institution	Soochow	Jiangsu
China	Local Institution	Urumqi	Xinjiang
China	Local Institution	Wuhan	Hubei
China	Local Institution	Xi'an	Shaanxi
China	Local Institution	Xi'an	Shaanxi
Colombia	Local Institution	Cordoba
Czechia	Local Institution	Ostrava - Poruba
Czechia	Local Institution	Praha 8
France	Local Institution	Caen
France	Local Institution	Rennes Cedex 9
France	Local Institution	Toulouse Cedex 9
France	Local Institution	Vandoeuvre-les-nancy
Germany	Local Institution	Bad Berka
Germany	Local Institution	Bochum
Germany	Local Institution	Dresden
Germany	Local Institution	Erlangen
Germany	Local Institution	Frankfurt am Main
Germany	Local Institution	Gauting
Germany	Local Institution	Grosshansdorf
Germany	Local Institution	Hamburg
Germany	Local Institution	Heidelberg
Germany	Local Institution	Kassel
Germany	Local Institution	Mainz
Germany	Local Institution	Mannheim
Germany	Local Institution	Munchen
Germany	Local Institution	Oldenburg
Germany	Local Institution	Ulm
Hong Kong	Local Institution	Hong Kong
Hong Kong	Local Institution	Kowloon
Hungary	Local Institution	Budapest
Hungary	Local Institution	Budapest
Hungary	Local Institution	Budapest
Hungary	Local Institution	Farkasgyepu
Hungary	Local Institution	Matrahaza
Hungary	Local Institution	Pecs
Hungary	Local Institution	Sopron
Hungary	Local Institution	Szolnok
Ireland	Local Institution	Dublin
Ireland	Local Institution	Dublin
Ireland	Local Institution	Limerick
Israel	Local Institution	Beer Sheva
Israel	Local Institution	Kfar-saba
Israel	Local Institution	Petah-tikva
Israel	Local Institution	Ramat-gan
Israel	Local Institution	Zerifin
Italy	Local Institution	Livorno
Italy	Local Institution	Lucca
Italy	Local Institution	Meldola (FC)
Italy	Local Institution	Siena
Japan	Local Institution	Akashi, Hyogo
Japan	Local Institution	Chuo-ku	Tokyo
Japan	Local Institution	Fukoka
Japan	Local Institution	Fukuoka
Japan	Local Institution	Hirakata-shi	Osaka
Japan	Local Institution	Kanazawa-shi	Ishikawa
Japan	Local Institution	Kashiwa	Chiba
Japan	Local Institution	Kurashiki-shi	Okayama
Japan	Local Institution	Kurashiki-shi	Okayama
Japan	Local Institution	Matsuyama-shi	Ehime
Japan	Local Institution	Nagoya	Aichi
Japan	Local Institution	Nagoya-shi	Aichi
Japan	Local Institution	Natori	Miyagi
Japan	Local Institution	Osaka
Japan	Local Institution	Oskaka
Japan	Local Institution	Sapporo	Hokkaido
Japan	Local Institution	Sapporo, Hokkaido
Japan	Local Institution	Sendai, Miyagi
Japan	Local Institution	Sunto-gun	Shizuoka
Japan	Local Institution	Takatsuki	Osaka
Japan	Local Institution	Tokyo
Japan	Local Institution	Ube-shi	Yamaguchi
Japan	Local Institution	Yokohama-Shi	Kanagawa
Japan	Local Institution	Yokohama-shi	Kanagawa
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Goyang-si	Gyeonggji-do
Korea, Republic of	Local Institution	Hwasun-eup, Hwasun-gun	Jeonnam
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Suwon
Korea, Republic of	Local Institution	Suwon
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	San Luis Potosi, S.l.p.
Netherlands	Local Institution	's-Hertogenbosch
Netherlands	Local Institution	Breda
Netherlands	Local Institution	Eindhoven
Peru	Local Institution	Cercado
Peru	Local Institution	Lima
Peru	Local Institution	Lima
Poland	Local Institution	Elblag
Poland	Local Institution	Karkow
Poland	Local Institution	Lublin
Poland	Local Institution	Otwock
Poland	Local Institution	Poznan
Poland	Local Institution	Torun
Poland	Local Institution	Warszawa
Portugal	Local Institution	Coimbra
Portugal	Local Institution	Lisboa
Romania	Local Institution	Bucuresti
Romania	Local Institution	Cluj
Romania	Local Institution	Cluj Napoca	Judetul CLUJ
Romania	Local Institution	Craiova	Judetul DOLJ
Russian Federation	Local Institution	Chelyabinsk
Russian Federation	Local Institution	Krasnodar
Russian Federation	Local Institution	Kursk
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Pyatigorsk
Russian Federation	Local Institution	Saint Petersburg
Russian Federation	Local Institution	Saint Petersburg
Russian Federation	Local Institution	St. Petersburg
Russian Federation	Local Institution	St. Petersburg
South Africa	Local Institution	Cape Town	Western CAPE
South Africa	Local Institution	Port Elizabeth	Eastern CAPE
South Africa	Local Institution	Pretoria
Spain	Local Institution	A Coruna	Galicia
Spain	Local Institution	Barcelona
Spain	Local Institution	Benidorm-alicante
Spain	Local Institution	Castellon
Spain	Local Institution	Lleida
Spain	Local Institution	Majadahonda
Spain	Local Institution	Malaga
Spain	Local Institution	Valencia
Sweden	Local Institution	Linkoping
Sweden	Local Institution	Stockholm
Sweden	Local Institution	Uppsala
Switzerland	Local Institution	Basel
Switzerland	Local Institution	Winterthur
Switzerland	Local Institution	Zuerich
Taiwan	Local Institution	Changhua City
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taoyuan County
Thailand	Local Institution	Chiang Mai
Thailand	Local Institution	Songkhla
United Kingdom	Local Institution	London
United Kingdom	Local Institution	London
United Kingdom	Local Institution	Preston
United Kingdom	Local Institution	Sutton
United Kingdom	Local Institution	Truro
United Kingdom	Local Institution	Withington	Manchester
United States	Ashland Bellefonte Cancer Center	Ashland	Kentucky
United States	Sutter Medical Center	Auburn	California
United States	Medical Oncology, LLC	Augusta	Georgia
United States	University Of Colorado Cancer Center	Aurora	Colorado
United States	Gabrail Cancer Center	Canton	Ohio
United States	Associated in Oncology and Hematology	Chattanooga	Tennessee
United States	Chattanooga Oncology Hematology Associates	Chattanooga	Tennessee
United States	Regional Cancer Care Associates, LLC/Cherry Hill Division	Cherry Hill	New Jersey
United States	Oncology Hematology Care, Incorporated	Cincinnati	Ohio
United States	University Hospitals	Cleveland	Ohio
United States	Florida Cancer Specialists S.	Fort Myers	Florida
United States	The Jones Clinic, PC	Germantown	Tennessee
United States	Genesis Cancer Center	Hot Springs	Arkansas
United States	University Of Texas, M. D. Anderson Cancer Center	Houston	Texas
United States	St. Francis Medical Group Oncology And Hematology Specialist	Indianapolis	Indiana
United States	Cancer Specialists, LLC	Jacksonville	Florida
United States	St. Luke'S Cancer Institute	Kansas City	Missouri
United States	Tennessee Cancer Specialists	Knoxville	Tennessee
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	UCSD Moores Cancer Center	La Jolla	California
United States	Lake City Cancer Care	Lake City	Florida
United States	University Of Kentucky	Lexington	Kentucky
United States	Southeast Nebraska Hematology & Oncology Consultants, P.C.	Lincoln	Nebraska
United States	Joe Arrington Cancer Research And Treatment Center	Lubbock	Texas
United States	Signal Point Clinical Research Center, Llc	Middletown	Ohio
United States	Mary Babb Randolph Cancer Center	Morgantown	West Virginia
United States	Montgomery Cancer Center	Mount Sterling	Kentucky
United States	Henry-Joyce Cancer Center	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Memorial Sloan Kettering Nassau	New York	New York
United States	Kaiser Permanente	Portland	Oregon
United States	Providence Portland Medical Center	Portland	Oregon
United States	Quincy Medical Group	Quincy	Illinois
United States	Virginia Cancer Institute	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Florida Cancer Specialists	Saint Petersburg	Florida
United States	Huntsman Cancer Hospital	Salt Lake City	Utah
United States	Presence Medical Group Hematology Oncology	Skokie	Illinois
United States	SIU School Of Medicine	Springfield	Illinois
United States	Oklahoma Cancer Specialists and Research Institute, LLC	Tulsa	Oklahoma
United States	Cancer Center Of Kansas	Wichita	Kansas
United States	St Joseph Mercy Hospital	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  Colombia,  Czechia,  France,  Germany,  Hong Kong,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Peru,  Poland,  Portugal,  Romania,  Russian Federation,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Randomization until date of death, up to March 2015, approximately 38 months
Secondary	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.	From randomization until date of death, up to March 2015, approximately 38 months
Secondary	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.	From randomization until disease progression, up to March 2015, approximately 38 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form