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Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin

Primary Purpose

Lung Cancer - Non Small Cell Squamous

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

About this trial

This is an interventional treatment trial for Lung Cancer - Non Small Cell Squamous

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:

  • Non small cell lung cancer (NSCLC) - squamous cell
  • Stage IV or recurrent NSCLC
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Brain Metastases
  • Autoimmune diseases

Sites / Locations

  • Sharp Memorial Hospital
  • Va Connecticut Healthcare System
  • Lynn Cancer Institute Center For Hematology-Oncology
  • Integrated Community Oncology Network
  • University Of Illinois At Chicago Medical Center
  • Quincy Medical Group
  • Presence Medical Group Hematology Oncology
  • Southern Illinois University School Of Medicine
  • St. Francis Hospital & Health Centers
  • Floyd Memorial Cancer Center Of Indiana
  • Kentucky Cancer Clinic
  • Norton Cancer Institute
  • Montgomery Cancer Center
  • St Joseph Mercy Hospital
  • University Of Kansas Cancer Center
  • Washington University School Of Medicine
  • Dartmouth-Hitchcock Medical Center
  • Clinical Research Alliance, Inc.
  • Durham Va Medical Center (111g)
  • Carolina Biooncology Institute
  • Novant Health Oncology Specialists
  • Gabrail Cancer Center Research
  • Oklahoma Oncology And Hematology, Pc Dba
  • Kaiser Permanente Northwest Region
  • Guthrie Medical Group, P.C.
  • Wjb Dorn Va Medical Center
  • Cancer Center Of The Carolinas
  • Associated in Oncology and Hematology
  • Tennessee Cancer Specialists
  • Thompson Oncology Group
  • Texas Oncology, PA - South Austin Cancer Center
  • Blue Ridge Cancer Care
  • Wisconsin Institutes for Medical Research
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ipilimumab + Paclitaxel and Carboplatin

Placebo + Paclitaxel and Carboplatin

Arm Description

Ipilimumab + Active Chemo Backbone Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses

Placebo + Active Chemo Backbone Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses

Outcomes

Primary Outcome Measures

Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.

Secondary Outcome Measures

Overall Survival (OS) in All Randomized Participants at Primary Endpoint
Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death. For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.

Full Information

First Posted
January 24, 2011
Last Updated
June 16, 2020
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01285609
Brief Title
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin
Official Title
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 16, 2011 (Actual)
Primary Completion Date
June 9, 2015 (Actual)
Study Completion Date
August 22, 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 Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.
Detailed Description
The primary objective is to compare Overall Survival (OS) of participants with Stage IV/recurrent NSCLC of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and carboplatin, and have received at least one dose of blinded study therapy (ipilimumab or placebo).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer - Non Small Cell Squamous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1289 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ipilimumab + Paclitaxel and Carboplatin
Arm Type
Experimental
Arm Description
Ipilimumab + Active Chemo Backbone Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
Arm Title
Placebo + Paclitaxel and Carboplatin
Arm Type
Placebo Comparator
Arm Description
Placebo + Active Chemo Backbone Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
BMS-734016
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol®
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 at Primary Endpoint
Description
Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
Time Frame
Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
Secondary Outcome Measure Information:
Title
Overall Survival (OS) in All Randomized Participants at Primary Endpoint
Description
Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
Time Frame
Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
Title
Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
Description
Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death. For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
Time Frame
Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)

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: Non small cell lung cancer (NSCLC) - squamous cell Stage IV or recurrent NSCLC Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: Brain Metastases Autoimmune diseases
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
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Va Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
Lynn Cancer Institute Center For Hematology-Oncology
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Integrated Community Oncology Network
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
University Of Illinois At Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
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
60076
Country
United States
Facility Name
Southern Illinois University School Of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9678
Country
United States
Facility Name
St. Francis Hospital & Health Centers
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Floyd Memorial Cancer Center Of Indiana
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Kentucky Cancer Clinic
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
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
University Of Kansas Cancer Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Washington University School Of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0001
Country
United States
Facility Name
Clinical Research Alliance, Inc.
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Durham Va Medical Center (111g)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Carolina Biooncology Institute
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Novant Health Oncology Specialists
City
Lexington
State/Province
North Carolina
ZIP/Postal Code
27295
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Oklahoma Oncology And Hematology, Pc Dba
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Kaiser Permanente Northwest Region
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Guthrie Medical Group, P.C.
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Wjb Dorn Va Medical Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29209
Country
United States
Facility Name
Cancer Center Of The Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Associated in Oncology and Hematology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Tennessee Cancer Specialists
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Thompson Oncology Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Texas Oncology, PA - South Austin Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Blue Ridge Cancer Care
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States
Facility Name
Wisconsin Institutes for Medical Research
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Local Institution
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878DVB
Country
Argentina
Facility Name
Local Institution
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
S2000DSV
Country
Argentina
Facility Name
Local Institution
City
San Miguel De Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Local Institution
City
Cordoba
ZIP/Postal Code
X5006HBF
Country
Argentina
Facility Name
Local Institution
City
Cordoba
ZIP/Postal Code
X5006IKK
Country
Argentina
Facility Name
Local Institution
City
Mendoza
ZIP/Postal Code
M5500AYB
Country
Argentina
Facility Name
Local Institution
City
Santa Fe
ZIP/Postal Code
S3000FFU
Country
Argentina
Facility Name
Local Institution
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Local Institution
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Local Institution
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Local Institution
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Facility Name
Local Institution
City
Graz
ZIP/Postal Code
8036
Country
Austria
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
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Local Institution
City
Liege
ZIP/Postal Code
4000
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
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60160-230
Country
Brazil
Facility Name
Local Institution
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-270
Country
Brazil
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Local Institution
City
Passo Fundo
State/Province
RIO Grande DO SUL
ZIP/Postal Code
99010260
Country
Brazil
Facility Name
Local Institution
City
Barretos
State/Province
SAO Paulo
ZIP/Postal Code
14784
Country
Brazil
Facility Name
Local Institution
City
Sao Jose dos Campos
State/Province
SAO Paulo
ZIP/Postal Code
12245
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
ZIP/Postal Code
90430
Country
Brazil
Facility Name
Local Institution
City
Ribeirao Preto
ZIP/Postal Code
14015
Country
Brazil
Facility Name
Local Institution
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01224-010
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
04039-901
Country
Brazil
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Local Institution
City
Oshawa
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Local Institution
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
7520378
Country
Chile
Facility Name
Local Institution
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8380455
Country
Chile
Facility Name
Local Institution
City
Vina Del Mar
State/Province
Valparaiso
ZIP/Postal Code
2540364
Country
Chile
Facility Name
Local Institution
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Local Institution
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Local Institution
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Facility Name
Local Institution
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430023
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Local Institution
City
Suzhou
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
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830011
Country
China
Facility Name
Local Institution
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
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
Santiago
ZIP/Postal Code
7630370
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
Monteria
State/Province
Cordoba
Country
Colombia
Facility Name
Local Institution
City
Pereira
State/Province
Risaralda
Country
Colombia
Facility Name
Local Institution
City
Ostrava
State/Province
Poruba
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Local Institution
City
Prague 2
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Local Institution
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Local Institution
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Local Institution
City
Pribram V-Zdabor
ZIP/Postal Code
26195
Country
Czechia
Facility Name
Local Institution
City
Usti Nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Local Institution
City
Znojmo
ZIP/Postal Code
669 02
Country
Czechia
Facility Name
Local Institution
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Local Institution
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Local Institution
City
Hillerod
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Local Institution
City
Naestved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Local Institution
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Local Institution
City
Caen Cedex 05
ZIP/Postal Code
14076
Country
France
Facility Name
Local Institution
City
Marseille Cedex 20
ZIP/Postal Code
13915
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Local Institution
City
Poitiers
ZIP/Postal Code
86000
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
99437
Country
Germany
Facility Name
Local Institution
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Local Institution
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Local Institution
City
Dresden
ZIP/Postal Code
01307
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
Grosshandsdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
D-21075
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
Lubeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Local Institution
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Local Institution
City
Muenchen
ZIP/Postal Code
81925
Country
Germany
Facility Name
Local Institution
City
Neumunster
ZIP/Postal Code
24534
Country
Germany
Facility Name
Local Institution
City
Nuernberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Local Institution
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Facility Name
Local Institution
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Local Institution
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Local Institution
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Facility Name
Local Institution
City
Hong Kong
ZIP/Postal Code
8525
Country
Hong Kong
Facility Name
Local Institution
City
Hong Kong
Country
Hong Kong
Facility Name
Local Institution
City
New Territories
ZIP/Postal Code
8520
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
Deszk
ZIP/Postal Code
6772
Country
Hungary
Facility Name
Local Institution
City
Farkasgyepu
ZIP/Postal Code
8582
Country
Hungary
Facility Name
Local Institution
City
Gyula
ZIP/Postal Code
5703
Country
Hungary
Facility Name
Local Institution
City
Matrahaza
ZIP/Postal Code
3233
Country
Hungary
Facility Name
Local Institution
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Local Institution
City
Pecs
ZIP/Postal Code
7602
Country
Hungary
Facility Name
Local Institution
City
Sopron
ZIP/Postal Code
9400
Country
Hungary
Facility Name
Local Institution
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Local Institution
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Local Institution
City
Dublin
ZIP/Postal Code
24
Country
Ireland
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
Galway
Country
Ireland
Facility Name
Local Institution
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Local Institution
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Local Institution
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Local Institution
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Local Institution
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Local Institution
City
Tel-aviv
ZIP/Postal Code
69710
Country
Israel
Facility Name
Local Institution
City
Tel-hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Local Institution
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Local Institution
City
Benevento
ZIP/Postal Code
82100
Country
Italy
Facility Name
Local Institution
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Local Institution
City
Lido Di Camaiore
ZIP/Postal Code
55041
Country
Italy
Facility Name
Local Institution
City
Lucca
ZIP/Postal Code
55100
Country
Italy
Facility Name
Local Institution
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Local Institution
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Facility Name
Local Institution
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution
City
Sondrio
ZIP/Postal Code
23100
Country
Italy
Facility Name
Local Institution
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Local Institution
City
Treviglio
ZIP/Postal Code
24047
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
277-8577
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-shi
State/Province
Miyagi
ZIP/Postal Code
9811293
Country
Japan
Facility Name
Local Institution
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
9808574
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
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5340021
Country
Japan
Facility Name
Local Institution
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
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
6738558
Country
Japan
Facility Name
Local Institution
City
Fukuoka
ZIP/Postal Code
8128582
Country
Japan
Facility Name
Local Institution
City
Matsuyama, Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Local Institution
City
Osakasayama-city
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Local Institution
City
Sapporo Hokkaido
ZIP/Postal Code
003-080
Country
Japan
Facility Name
Local Institution
City
Sapporo, Hokkaido
ZIP/Postal Code
0608648
Country
Japan
Facility Name
Local Institution
City
Sendai, Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
Local Institution
City
Takatsuki
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Local Institution
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Local Institution
City
Cheonju-si
State/Province
Chungcheongbuk-do
ZIP/Postal Code
361-771
Country
Korea, Republic of
Facility Name
Local Institution
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Local Institution
City
Suwon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
State/Province
Kangnam-gu
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
State/Province
Seodaemungu
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Local Institution
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Local Institution
City
Gyeonggi-do
ZIP/Postal Code
463-802
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
134-791
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
135-720
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
137-701
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
Facility Name
Local Institution
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Local Institution
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Local Institution
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45170
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Local Institution
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Local Institution
City
Harderwijk
ZIP/Postal Code
3844 DG
Country
Netherlands
Facility Name
Local Institution
City
Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Local Institution
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Local Institution
City
Trujillo
State/Province
LA Libertad
Country
Peru
Facility Name
Local Institution
City
Arequipa
Country
Peru
Facility Name
Local Institution
City
Cercado
Country
Peru
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
LIMA 11
Country
Peru
Facility Name
Local Institution
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Local Institution
City
Gdansk- Zaspa
ZIP/Postal Code
80-462
Country
Poland
Facility Name
Local Institution
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Local Institution
City
Grudziadz
ZIP/Postal Code
86-300
Country
Poland
Facility Name
Local Institution
City
Olsztyn
ZIP/Postal Code
10-357
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
Szczecin
ZIP/Postal Code
70-891
Country
Poland
Facility Name
Local Institution
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Local Institution
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution
City
Sao Martinho Do Bispo
State/Province
Coimbra
ZIP/Postal Code
3041801
Country
Portugal
Facility Name
Local Institution
City
Lisboa
ZIP/Postal Code
1099023
Country
Portugal
Facility Name
Local Institution
City
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
Facility Name
Local Institution
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Local Institution
City
Santa Maria Da Feira
ZIP/Postal Code
4520211
Country
Portugal
Facility Name
Local Institution
City
Vila Nova De Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Local Institution
City
Bucharest
ZIP/Postal Code
030171
Country
Romania
Facility Name
Local Institution
City
Bucuresti
ZIP/Postal Code
010976
Country
Romania
Facility Name
Local Institution
City
Cluj Napoca
ZIP/Postal Code
400058
Country
Romania
Facility Name
Local Institution
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Local Institution
City
Suceava
ZIP/Postal Code
720237
Country
Romania
Facility Name
Local Institution
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Facility Name
Local Institution
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Local Institution
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
125009
Country
Russian Federation
Facility Name
Local Institution
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Local Institution
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Local Institution
City
St-Peterburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Local Institution
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
Local Institution
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Local Institution
City
Vereeniging
State/Province
Gauteng
ZIP/Postal Code
1939
Country
South Africa
Facility Name
Local Institution
City
Panorama,cape Town
State/Province
Western CAPE
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Local Institution
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Local Institution
City
Durban
ZIP/Postal Code
4067
Country
South Africa
Facility Name
Local Institution
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Local Institution
City
Avila
ZIP/Postal Code
05004
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
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution
City
Manresa
ZIP/Postal Code
08243
Country
Spain
Facility Name
Local Institution
City
Ourense
ZIP/Postal Code
32005
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Local Institution
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Local Institution
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Local Institution
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Local Institution
City
Umea
ZIP/Postal Code
SE-901 85
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
Changhua City
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Local Institution
City
Chiayi
ZIP/Postal Code
61363
Country
Taiwan
Facility Name
Local Institution
City
Kaohsiung County
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
407.5
Country
Taiwan
Facility Name
Local Institution
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Local Institution
City
Taipei
Country
Taiwan
Facility Name
Local Institution
City
Bangkok
State/Province
Tungpayathai
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Local Institution
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Local Institution
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Local Institution
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
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
Dundee
State/Province
Angus/forfarshire
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Local Institution
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Local Institution
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Local Institution
City
Nottingham
ZIP/Postal Code
NG51PB
Country
United Kingdom
Facility Name
Local Institution
City
Sheffield
ZIP/Postal Code
s10 2SJ
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin

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