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

Primary Purpose

Small Cell Lung Carcinoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ipilimumab
Placebo matching Ipilimumab
Etoposide
Cisplatin
Carboplatin
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Genesis Cancer Center
  • Sutter Medical Center
  • UCSD Moores Cancer Center
  • University Of Colorado Cancer Center
  • Florida Cancer Specialists S.
  • Cancer Specialists, LLC
  • Lake City Cancer Care
  • Florida Cancer Specialists
  • Medical Oncology, LLC
  • Quincy Medical Group
  • Presence Medical Group Hematology Oncology
  • SIU School Of Medicine
  • St. Francis Medical Group Oncology And Hematology Specialist
  • Cancer Center Of Kansas
  • Ashland Bellefonte Cancer Center
  • University Of Kentucky
  • Montgomery Cancer Center
  • St Joseph Mercy Hospital
  • St. Luke'S Cancer Institute
  • Southeast Nebraska Hematology & Oncology Consultants, P.C.
  • Regional Cancer Care Associates, LLC/Cherry Hill Division
  • Memorial Sloan Kettering Nassau
  • Gabrail Cancer Center
  • Oncology Hematology Care, Incorporated
  • University Hospitals
  • Signal Point Clinical Research Center, Llc
  • Oklahoma Cancer Specialists and Research Institute, LLC
  • Providence Portland Medical Center
  • Kaiser Permanente
  • Chattanooga Oncology Hematology Associates
  • Associated in Oncology and Hematology
  • The Jones Clinic, PC
  • Tennessee Cancer Specialists
  • Thompson Cancer Survival Center
  • Tennessee Oncology, PLLC
  • Henry-Joyce Cancer Center
  • University Of Texas, M. D. Anderson Cancer Center
  • Joe Arrington Cancer Research And Treatment Center
  • Huntsman Cancer Hospital
  • Virginia Cancer Institute
  • Virginia Commonwealth University
  • Mary Babb Randolph Cancer Center
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ipilimumab+Etoposide+Cisplatin/Carboplatin

Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin

Arm Description

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 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 10, 2011
Last Updated
July 6, 2020
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01450761
Brief 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
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 13, 2011 (Actual)
Primary Completion Date
March 19, 2015 (Actual)
Study Completion Date
May 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1351 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ipilimumab+Etoposide+Cisplatin/Carboplatin
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy, BMS-734016
Intervention Type
Biological
Intervention Name(s)
Placebo matching Ipilimumab
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
Etopophos, Neoposid, Eposin
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Primary Outcome Measure Information:
Title
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy
Description
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.
Time Frame
Randomization until date of death, up to March 2015, approximately 38 months
Secondary Outcome Measure Information:
Title
Overall Survival in All Randomized Participants
Description
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.
Time Frame
From randomization until date of death, up to March 2015, approximately 38 months
Title
Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy
Description
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.
Time Frame
From randomization until disease progression, up to March 2015, approximately 38 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Genesis Cancer Center
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Sutter Medical Center
City
Auburn
State/Province
California
ZIP/Postal Code
95602
Country
United States
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University Of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Florida Cancer Specialists S.
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Cancer Specialists, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Lake City Cancer Care
City
Lake City
State/Province
Florida
ZIP/Postal Code
32024
Country
United States
Facility Name
Florida Cancer Specialists
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Medical Oncology, LLC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Quincy Medical Group
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Facility Name
Presence Medical Group Hematology Oncology
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
SIU School Of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9678
Country
United States
Facility Name
St. Francis Medical Group Oncology And Hematology Specialist
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Cancer Center Of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Ashland Bellefonte Cancer Center
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
Country
United States
Facility Name
University Of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
Montgomery Cancer Center
City
Mount Sterling
State/Province
Kentucky
ZIP/Postal Code
40353
Country
United States
Facility Name
St Joseph Mercy Hospital
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
St. Luke'S Cancer Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Southeast Nebraska Hematology & Oncology Consultants, P.C.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Regional Cancer Care Associates, LLC/Cherry Hill Division
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
Memorial Sloan Kettering Nassau
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Oncology Hematology Care, Incorporated
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Signal Point Clinical Research Center, Llc
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Oklahoma Cancer Specialists and Research Institute, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Kaiser Permanente
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Chattanooga Oncology Hematology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Associated in Oncology and Hematology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
The Jones Clinic, PC
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Tennessee Cancer Specialists
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Thompson Cancer Survival Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Henry-Joyce Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University Of Texas, M. D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Joe Arrington Cancer Research And Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Huntsman Cancer Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Mary Babb Randolph Cancer Center
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Local Institution
City
Berazategui
State/Province
Buenos Aires
ZIP/Postal Code
B1884BBF
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Local Institution
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1226ANZ
Country
Argentina
Facility Name
Local Institution
City
Provincia De Sante Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Facility Name
Local Institution
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Local Institution
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Local Institution
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Local Institution
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Local Institution
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Local Institution
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Facility Name
Local Institution
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Local Institution
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1145
Country
Austria
Facility Name
Local Institution
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Local Institution
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution
City
Sint Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Local Institution
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Local Institution
City
Passo Fundo, RS
ZIP/Postal Code
99010-260
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo/SP
ZIP/Postal Code
CEP 01246000
Country
Brazil
Facility Name
Local Institution
City
SP
ZIP/Postal Code
12245-750
Country
Brazil
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Local Institution
City
Vina Del Mar
State/Province
Valparaiso
ZIP/Postal Code
Region de Valparaiso, 2540364
Country
Chile
Facility Name
Local Institution
City
Santiago
ZIP/Postal Code
8360160
Country
Chile
Facility Name
Local Institution
City
Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Local Institution
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Local Institution
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Local Institution
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150084
Country
China
Facility Name
Local Institution
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430023
Country
China
Facility Name
Local Institution
City
Nangjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Local Institution
City
Soochow
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
Local Institution
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Local Institution
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Facility Name
Local Institution
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Local Institution
City
Chengdu City
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Local Institution
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830011
Country
China
Facility Name
Local Institution
City
Hangzhou City
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Local Institution
City
Hangzhou City
State/Province
Zhejiang
Country
China
Facility Name
Local Institution
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Local Institution
City
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Local Institution
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Local Institution
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Local Institution
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Local Institution
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Local Institution
City
Cordoba
Country
Colombia
Facility Name
Local Institution
City
Ostrava - Poruba
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Local Institution
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Local Institution
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Local Institution
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Local Institution
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Local Institution
City
Bad Berka
ZIP/Postal Code
99438
Country
Germany
Facility Name
Local Institution
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Local Institution
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Local Institution
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Local Institution
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Local Institution
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Local Institution
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Local Institution
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Local Institution
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
Local Institution
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Local Institution
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Local Institution
City
Munchen
ZIP/Postal Code
81925
Country
Germany
Facility Name
Local Institution
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Facility Name
Local Institution
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Local Institution
City
Hong Kong
Country
Hong Kong
Facility Name
Local Institution
City
Kowloon
Country
Hong Kong
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
H-1121
Country
Hungary
Facility Name
Local Institution
City
Farkasgyepu
ZIP/Postal Code
8582
Country
Hungary
Facility Name
Local Institution
City
Matrahaza
ZIP/Postal Code
3233
Country
Hungary
Facility Name
Local Institution
City
Pecs
ZIP/Postal Code
H-7623
Country
Hungary
Facility Name
Local Institution
City
Sopron
ZIP/Postal Code
9400
Country
Hungary
Facility Name
Local Institution
City
Szolnok
ZIP/Postal Code
H-5000
Country
Hungary
Facility Name
Local Institution
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
Local Institution
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Local Institution
City
Limerick
Country
Ireland
Facility Name
Local Institution
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Local Institution
City
Kfar-saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Local Institution
City
Petah-tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Local Institution
City
Ramat-gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Local Institution
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Local Institution
City
Livorno
ZIP/Postal Code
57100
Country
Italy
Facility Name
Local Institution
City
Lucca
ZIP/Postal Code
55100
Country
Italy
Facility Name
Local Institution
City
Meldola (FC)
ZIP/Postal Code
47014
Country
Italy
Facility Name
Local Institution
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4600001
Country
Japan
Facility Name
Local Institution
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4648681
Country
Japan
Facility Name
Local Institution
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
2778577
Country
Japan
Facility Name
Local Institution
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
7910280
Country
Japan
Facility Name
Local Institution
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
0608648
Country
Japan
Facility Name
Local Institution
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
9208641
Country
Japan
Facility Name
Local Institution
City
Yokohama-Shi
State/Province
Kanagawa
ZIP/Postal Code
2360051
Country
Japan
Facility Name
Local Institution
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
2408555
Country
Japan
Facility Name
Local Institution
City
Natori
State/Province
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Facility Name
Local Institution
City
Kurashiki-shi
State/Province
Okayama
ZIP/Postal Code
7010192
Country
Japan
Facility Name
Local Institution
City
Kurashiki-shi
State/Province
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Facility Name
Local Institution
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
5731191
Country
Japan
Facility Name
Local Institution
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
5698686
Country
Japan
Facility Name
Local Institution
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
4118777
Country
Japan
Facility Name
Local Institution
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Local Institution
City
Ube-shi
State/Province
Yamaguchi
ZIP/Postal Code
7550241
Country
Japan
Facility Name
Local Institution
City
Akashi, Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Local Institution
City
Fukoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Local Institution
City
Fukuoka
ZIP/Postal Code
8128582
Country
Japan
Facility Name
Local Institution
City
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Local Institution
City
Oskaka
ZIP/Postal Code
5340021
Country
Japan
Facility Name
Local Institution
City
Sapporo, Hokkaido
ZIP/Postal Code
0030804
Country
Japan
Facility Name
Local Institution
City
Sendai, Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
Local Institution
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Local Institution
City
Goyang-si
State/Province
Gyeonggji-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Local Institution
City
Hwasun-eup, Hwasun-gun
State/Province
Jeonnam
ZIP/Postal Code
519-763
Country
Korea, Republic of
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Local Institution
City
Suwon
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
Local Institution
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Local Institution
City
San Luis Potosi, S.l.p.
ZIP/Postal Code
C.P. 78218
Country
Mexico
Facility Name
Local Institution
City
's-Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Local Institution
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Local Institution
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Local Institution
City
Cercado
Country
Peru
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
027
Country
Peru
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
Lima 41
Country
Peru
Facility Name
Local Institution
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Local Institution
City
Karkow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Local Institution
City
Lublin
ZIP/Postal Code
20-950
Country
Poland
Facility Name
Local Institution
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Local Institution
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Local Institution
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution
City
Coimbra
ZIP/Postal Code
3041853
Country
Portugal
Facility Name
Local Institution
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Local Institution
City
Cluj Napoca
State/Province
Judetul CLUJ
ZIP/Postal Code
400058
Country
Romania
Facility Name
Local Institution
City
Craiova
State/Province
Judetul DOLJ
ZIP/Postal Code
200385
Country
Romania
Facility Name
Local Institution
City
Bucuresti
Country
Romania
Facility Name
Local Institution
City
Cluj
ZIP/Postal Code
400015
Country
Romania
Facility Name
Local Institution
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Local Institution
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Local Institution
City
Kursk
ZIP/Postal Code
305035
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Local Institution
City
Pyatigorsk
ZIP/Postal Code
35702
Country
Russian Federation
Facility Name
Local Institution
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Local Institution
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Local Institution
City
Port Elizabeth
State/Province
Eastern CAPE
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Local Institution
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Local Institution
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Local Institution
City
A Coruna
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution
City
Benidorm-alicante
ZIP/Postal Code
03501
Country
Spain
Facility Name
Local Institution
City
Castellon
ZIP/Postal Code
12002
Country
Spain
Facility Name
Local Institution
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Local Institution
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Local Institution
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Local Institution
City
Linkoping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Local Institution
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Local Institution
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Local Institution
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Local Institution
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
Local Institution
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Local Institution
City
Changhua City
ZIP/Postal Code
R.O.C.
Country
Taiwan
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Local Institution
City
Taoyuan County
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Local Institution
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Local Institution
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Local Institution
City
Withington
State/Province
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Local Institution
City
London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Local Institution
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Local Institution
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Local Institution
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Local Institution
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27458307
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. Erratum In: J Clin Oncol. 2019 Dec 1;37(34):3327.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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