Clinical trial NCT01285609: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer - Non Small Cell Squamous
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-01-28
Enrollment: 1289
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 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).

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

Primary outcomes:
measure: Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
timeFrame: 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 outcomes:
measure: Overall Survival (OS) in All Randomized Participants at Primary Endpoint
timeFrame: 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)
measure: 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
timeFrame: 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)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: West Haven
country: United States
facility: Va Connecticut Healthcare System
state: Connecticut
city: Boca Raton
country: United States
facility: Lynn Cancer Institute Center For Hematology-Oncology
state: Florida
city: Jacksonville
country: United States
facility: Integrated Community Oncology Network
state: Florida
city: Chicago
country: United States
facility: University Of Illinois At Chicago Medical Center
state: Illinois
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: Southern Illinois University School Of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: St. Francis Hospital & Health Centers
state: Indiana
city: New Albany
country: United States
facility: Floyd Memorial Cancer Center Of Indiana
state: Indiana
city: Hazard
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
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: University Of Kansas Cancer Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Lake Success
country: United States
facility: Clinical Research Alliance, Inc.
state: New York
city: Durham
country: United States
facility: Durham Va Medical Center (111g)
state: North Carolina
city: Huntersville
country: United States
facility: Carolina Biooncology Institute
state: North Carolina
city: Lexington
country: United States
facility: Novant Health Oncology Specialists
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Oncology And Hematology, Pc Dba
state: Oklahoma
city: Portland
country: United States
facility: Kaiser Permanente Northwest Region
state: Oregon
city: Sayre
country: United States
facility: Guthrie Medical Group, P.C.
state: Pennsylvania
city: Columbia
country: United States
facility: Wjb Dorn Va Medical Center
state: South Carolina
city: Greenville
country: United States
facility: Cancer Center Of The Carolinas
state: South Carolina
city: Chattanooga
country: United States
facility: Associated in Oncology and Hematology
state: Tennessee
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Knoxville
country: United States
facility: Thompson Oncology Group
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology, PA - South Austin Cancer Center
state: Texas
city: Blacksburg
country: United States
facility: Blue Ridge Cancer Care
state: Virginia
city: Madison
country: United States
facility: Wisconsin Institutes for Medical Research
state: Wisconsin
city: Quilmes
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution
state: Santa FE
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution
state: Tucuman
city: Cordoba
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Mendoza
country: Argentina
facility: Local Institution
city: Santa Fe
country: Argentina
facility: Local Institution
city: Bedford Park
country: Australia
facility: Local Institution
state: South Australia
city: Box Hill
country: Australia
facility: Local Institution
state: Victoria
city: Frankston
country: Australia
facility: Local Institution
state: Victoria
city: Heidelberg
country: Australia
facility: Local Institution
state: Victoria
city: Wodonga
country: Australia
facility: Local Institution
state: Victoria
city: Graz
country: Austria
facility: Local Institution
city: Linz
country: Austria
facility: Local Institution
city: Salzburg
country: Austria
facility: Local Institution
city: Aalst
country: Belgium
facility: Local Institution
city: Liege
country: Belgium
facility: Local Institution
city: Sint Niklaas
country: Belgium
facility: Local Institution
city: Yvoir
country: Belgium
facility: Local Institution
city: Fortaleza
country: Brazil
facility: Local Institution
state: Ceara
city: Belo Horizonte
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Passo Fundo
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Local Institution
state: SAO Paulo
city: Sao Jose dos Campos
country: Brazil
facility: Local Institution
state: SAO Paulo
city: Porto Alegre
country: Brazil
facility: Local Institution
city: Ribeirao Preto
country: Brazil
facility: Local Institution
city: Rio de Janeiro
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Oshawa
country: Canada
facility: Local Institution
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Vina Del Mar
country: Chile
facility: Local Institution
state: Valparaiso
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Guanzhou
country: China
facility: Local Institution
state: Guangdong
city: Shantou
country: China
facility: Local Institution
state: Guangdong
city: Wuhan
country: China
facility: Local Institution
state: Hubei
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Suzhou
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: Urumqi
country: China
facility: Local Institution
state: Xinjiang
city: Hangzhou
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: Santiago
country: China
facility: Local Institution
city: Shanghai
country: China
facility: Local Institution
city: Shanghai
country: China
facility: Local Institution
city: Monteria
country: Colombia
facility: Local Institution
state: Cordoba
city: Pereira
country: Colombia
facility: Local Institution
state: Risaralda
city: Ostrava
country: Czechia
facility: Local Institution
state: Poruba
city: Prague 2
country: Czechia
facility: Local Institution
city: Praha 5
country: Czechia
facility: Local Institution
city: Praha 8
country: Czechia
facility: Local Institution
city: Pribram V-Zdabor
country: Czechia
facility: Local Institution
city: Usti Nad Labem
country: Czechia
facility: Local Institution
city: Znojmo
country: Czechia
facility: Local Institution
city: Aalborg
country: Denmark
facility: Local Institution
city: Herlev
country: Denmark
facility: Local Institution
city: Hillerod
country: Denmark
facility: Local Institution
city: Naestved
country: Denmark
facility: Local Institution
city: Odense
country: Denmark
facility: Local Institution
city: Caen Cedex 05
country: France
facility: Local Institution
city: Marseille Cedex 20
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Poitiers
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: Darmstadt
country: Germany
facility: Local Institution
city: Dresden
country: Germany
facility: Local Institution
city: Frankfurt Am Main
country: Germany
facility: Local Institution
city: Gauting
country: Germany
facility: Local Institution
city: Grosshandsdorf
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: Lubeck
country: Germany
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
city: Muenchen
country: Germany
facility: Local Institution
city: Neumunster
country: Germany
facility: Local Institution
city: Nuernberg
country: Germany
facility: Local Institution
city: Regensburg
country: Germany
facility: Local Institution
city: Tuebingen
country: Germany
facility: Local Institution
city: Ulm
country: Germany
facility: Local Institution
city: Villingen-Schwenningen
country: Germany
facility: Local Institution
city: Hong Kong
country: Hong Kong
facility: Local Institution
city: Hong Kong
country: Hong Kong
facility: Local Institution
city: New Territories
country: Hong Kong
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Deszk
country: Hungary
facility: Local Institution
city: Farkasgyepu
country: Hungary
facility: Local Institution
city: Gyula
country: Hungary
facility: Local Institution
city: Matrahaza
country: Hungary
facility: Local Institution
city: Nyiregyhaza
country: Hungary
facility: Local Institution
city: Pecs
country: Hungary
facility: Local Institution
city: Sopron
country: Hungary
facility: Local Institution
city: Szekesfehervar
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: Dublin
country: Ireland
facility: Local Institution
city: Galway
country: Ireland
facility: Local Institution
city: Beer Sheva
country: Israel
facility: Local Institution
city: Haifa
country: Israel
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Nahariya
country: Israel
facility: Local Institution
city: Petah-Tikva
country: Israel
facility: Local Institution
city: Rehovot
country: Israel
facility: Local Institution
city: Tel Aviv
country: Israel
facility: Local Institution
city: Tel-aviv
country: Israel
facility: Local Institution
city: Tel-hashomer
country: Israel
facility: Local Institution
city: Zerifin
country: Israel
facility: Local Institution
city: Benevento
country: Italy
facility: Local Institution
city: Bologna
country: Italy
facility: Local Institution
city: Lido Di Camaiore
country: Italy
facility: Local Institution
city: Lucca
country: Italy
facility: Local Institution
city: Monza
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Perugia
country: Italy
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution
city: Sondrio
country: Italy
facility: Local Institution
city: Terni
country: Italy
facility: Local Institution
city: Treviglio
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: 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-shi
country: Japan
facility: Local Institution
state: Miyagi
city: Sendai
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: Osaka-shi
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: Fukuoka
country: Japan
facility: Local Institution
city: Matsuyama, Ehime
country: Japan
facility: Local Institution
city: Osakasayama-city
country: Japan
facility: Local Institution
city: Sapporo Hokkaido
country: Japan
facility: Local Institution
city: Sapporo, Hokkaido
country: Japan
facility: Local Institution
city: Sendai, Miyagi
country: Japan
facility: Local Institution
city: Takatsuki
country: Japan
facility: Local Institution
city: Tokyo
country: Japan
facility: Local Institution
city: Cheonju-si
country: Korea, Republic of
facility: Local Institution
state: Chungcheongbuk-do
city: Goyang-si
country: Korea, Republic of
facility: Local Institution
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Local Institution
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Local Institution
state: Kangnam-gu
city: Seoul
country: Korea, Republic of
facility: Local Institution
state: Seodaemungu
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Gyeonggi-do
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: 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: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Zapopan
country: Mexico
facility: Local Institution
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo LEON
city: Breda
country: Netherlands
facility: Local Institution
city: Harderwijk
country: Netherlands
facility: Local Institution
city: Hertogenbosch
country: Netherlands
facility: Local Institution
city: Nieuwegein
country: Netherlands
facility: Local Institution
city: Trujillo
country: Peru
facility: Local Institution
state: LA Libertad
city: Arequipa
country: Peru
facility: Local Institution
city: Cercado
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Elblag
country: Poland
facility: Local Institution
city: Gdansk- Zaspa
country: Poland
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
city: Grudziadz
country: Poland
facility: Local Institution
city: Olsztyn
country: Poland
facility: Local Institution
city: Otwock
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Szczecin
country: Poland
facility: Local Institution
city: Torun
country: Poland
facility: Local Institution
city: Warsaw
country: Poland
facility: Local Institution
city: Sao Martinho Do Bispo
country: Portugal
facility: Local Institution
state: Coimbra
city: Lisboa
country: Portugal
facility: Local Institution
city: Lisboa
country: Portugal
facility: Local Institution
city: Porto
country: Portugal
facility: Local Institution
city: Santa Maria Da Feira
country: Portugal
facility: Local Institution
city: Vila Nova De Gaia
country: Portugal
facility: Local Institution
city: Bucharest
country: Romania
facility: Local Institution
city: Bucuresti
country: Romania
facility: Local Institution
city: Cluj Napoca
country: Romania
facility: Local Institution
city: Sibiu
country: Romania
facility: Local Institution
city: Suceava
country: Romania
facility: Local Institution
city: Timisoara
country: Romania
facility: Local Institution
city: Chelyabinsk
country: Russian Federation
facility: Local Institution
city: Kazan
country: Russian Federation
facility: Local Institution
city: Moscow
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: St-Peterburg
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: Tula
country: Russian Federation
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Vereeniging
country: South Africa
facility: Local Institution
state: Gauteng
city: Panorama,cape Town
country: South Africa
facility: Local Institution
state: Western CAPE
city: Cape Town
country: South Africa
facility: Local Institution
city: Durban
country: South Africa
facility: Local Institution
city: Barakaldo
country: Spain
facility: Local Institution
state: Vizcaya
city: Avila
country: Spain
facility: Local Institution
city: Benidorm-alicante
country: Spain
facility: Local Institution
city: Castellon
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Manresa
country: Spain
facility: Local Institution
city: Ourense
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Gothenburg
country: Sweden
facility: Local Institution
city: Lund
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Umea
country: Sweden
facility: Local Institution
city: Basel
country: Switzerland
facility: Local Institution
city: Winterthur
country: Switzerland
facility: Local Institution
city: Changhua City
country: Taiwan
facility: Local Institution
city: Chiayi
country: Taiwan
facility: Local Institution
city: Kaohsiung County
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Taipei City
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
state: Tungpayathai
city: Bangkok
country: Thailand
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
city: Chiang Mai
country: Thailand
facility: Local Institution
city: Songkhla
country: Thailand
facility: Local Institution
city: Dundee
country: United Kingdom
facility: Local Institution
state: Angus/forfarshire
city: Truro
country: United Kingdom
facility: Local Institution
state: Cornwall
city: Southampton
country: United Kingdom
facility: Local Institution
state: Hampshire
city: Nottingham
country: United Kingdom
facility: Local Institution
city: Sheffield
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: