Clinical trial NCT00457392: A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone
Official title: A Multicenter, Randomized, Double-Blind, Controlled Phase 3, Efficacy And Safety Study Of Sunitinib (SU011248) In Patients With Advanced/Metastatic Non-Small Cell Lung Cancer Treated With Erlotinib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Non-Small Cell Lung
Keywords: Non-small cell lung cancer
sunitinib
erlotinib
Phase 3
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-04-06
Enrollment: 960
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: This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen.


Eligibility criteria: Inclusion Criteria:

* Patients with locally advanced/metastatic non-small cell lung cancer
* Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen

Exclusion Criteria:

* Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitor (with the exception of bevacizumab) or other angiogenesis inhibitors
* History of or known brain metastases

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline to death or 28 days after last dose for the last participant
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline to disease progression or death due to any cause or 28 days after last dose
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Baseline to disease progression or discontinuation from study or 28 days after last dose
measure: Duration of Response (DR)
timeFrame: Baseline to disease progression or death or discontinuation from study or 28 days after last dose
measure: One-year Survival Probability
timeFrame: Baseline until death or until 28 days after last dose for the last participant
measure: EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score
timeFrame: Baseline and End of Treatment (EOT) or Withdrawal
Other outcomes:
Locations:
city: Florence
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Muscle Shoals
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Scottsdale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Hot Springs
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Antioch
country: United States
facility: Pfizer Investigational Site
state: California
city: Burbank
country: United States
facility: Pfizer Investigational Site
state: California
city: Downey
country: United States
facility: Pfizer Investigational Site
state: California
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: Montebello
country: United States
facility: Pfizer Investigational Site
state: California
city: Pleasant Hill
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Leandro
country: United States
facility: Pfizer Investigational Site
state: California
city: Whittier
country: United States
facility: Pfizer Investigational Site
state: California
city: Fairfield
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Brooksville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Cocoa Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Merritt Island
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Rockledge
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Titusville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Athens
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Goshen
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Council Bluffs
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Lafayette
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Bethesda
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Troy
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Corinth
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Tupelo
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Peters
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Jamaica
country: United States
facility: Pfizer Investigational Site
state: New York
city: Norman
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Lancaster
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Grapevine
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Irving
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bountiful
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Layton
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Murray
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Provo
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Sandy
country: United States
facility: Pfizer Investigational Site
state: Utah
city: West Valley
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Kennewick
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
state: Capital Federal
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
state: Capital Federal
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Cordoba
country: Argentina
facility: Pfizer Investigational Site
city: Grimmenstein
country: Austria
facility: Pfizer Investigational Site
city: Innsbruck
country: Austria
facility: Pfizer Investigational Site
city: Linz
country: Austria
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Liege
country: Belgium
facility: Pfizer Investigational Site
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Barretos
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Levis
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Rimouski
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Independencia
country: Chile
facility: Pfizer Investigational Site
state: Santiago, RM
city: Providencia
country: Chile
facility: Pfizer Investigational Site
state: Santiago, RM
city: Santiago
country: Chile
facility: Pfizer Investigational Site
city: Medellin
country: Colombia
facility: Pfizer Investigational Site
state: Antioquia
city: Medellin
country: Colombia
facility: Pfizer Investigational Site
state: Antioquia
city: Ceske Budejovice
country: Czech Republic
facility: Pfizer Investigational Site
city: Nova Ves pod Plesi
country: Czech Republic
facility: Pfizer Investigational Site
city: Olomouc
country: Czech Republic
facility: Pfizer Investigational Site
city: Ostrava-Poruba
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 2
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 8
country: Czech Republic
facility: Pfizer Investigational Site
city: Pribram V
country: Czech Republic
facility: Pfizer Investigational Site
city: Tabor
country: Czech Republic
facility: Pfizer Investigational Site
city: Usti nad Labem
country: Czech Republic
facility: Pfizer Investigational Site
city: Herlev
country: Denmark
facility: Pfizer Investigational Site
city: Hilleroed
country: Denmark
facility: Pfizer Investigational Site
city: Koebenhavn OE
country: Denmark
facility: Pfizer Investigational Site
city: Odense
country: Denmark
facility: Pfizer Investigational Site
city: Bad Berka
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Dresden
country: Germany
facility: Pfizer Investigational Site
city: Ebensfeld
country: Germany
facility: Pfizer Investigational Site
city: Essen
country: Germany
facility: Pfizer Investigational Site
city: Gauting
country: Germany
facility: Pfizer Investigational Site
city: Grosshansdorf
country: Germany
facility: Pfizer Investigational Site
city: Halle (Saale)
country: Germany
facility: Pfizer Investigational Site
city: Heidelberg
country: Germany
facility: Pfizer Investigational Site
city: Homburg
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Tuebingen
country: Germany
facility: Pfizer Investigational Site
city: Wiesbaden
country: Germany
facility: Pfizer Investigational Site
city: Heraklion
country: Greece
facility: Pfizer Investigational Site
state: Crete
city: Alexandroupoli
country: Greece
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Kifisia, Athens
country: Greece
facility: Pfizer Investigational Site
city: Kowloon
country: Hong Kong
facility: Pfizer Investigational Site
city: Shatin, NT
country: Hong Kong
facility: Pfizer Investigational Site
city: Tuen Mun,
country: Hong Kong
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Deszk
country: Hungary
facility: Pfizer Investigational Site
city: Gyula
country: Hungary
facility: Pfizer Investigational Site
city: Matrahaza
country: Hungary
facility: Pfizer Investigational Site
city: Szekesfehervar
country: Hungary
facility: Pfizer Investigational Site
city: Zalaegerszeg-Pozva
country: Hungary
facility: Pfizer Investigational Site
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Grosseto
country: Italy
facility: Pfizer Investigational Site
city: Mantova
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Monza (MI)
country: Italy
facility: Pfizer Investigational Site
city: Novara
country: Italy
facility: Pfizer Investigational Site
city: Orbassano (TO)
country: Italy
facility: Pfizer Investigational Site
city: Parma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Rozzano (MI)
country: Italy
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Enschede
country: Netherlands
facility: Pfizer Investigational Site
state: Ov
city: 's-Hertogenbosch
country: Netherlands
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Arnhem
country: Netherlands
facility: Pfizer Investigational Site
city: Harderwijk
country: Netherlands
facility: Pfizer Investigational Site
city: Maastricht
country: Netherlands
facility: Pfizer Investigational Site
city: Rotterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Rotterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Kristiansand S
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Stavanger
country: Norway
facility: Pfizer Investigational Site
city: Tromso
country: Norway
facility: Pfizer Investigational Site
city: Trondheim
country: Norway
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Opole
country: Poland
facility: Pfizer Investigational Site
city: Otwock
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Zielona Gora
country: Poland
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: St-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Kvetnica pri Poprade
country: Slovakia
facility: Pfizer Investigational Site
city: Nitra-Zobor
country: Slovakia
facility: Pfizer Investigational Site
city: Zilina
country: Slovakia
facility: Pfizer Investigational Site
city: Sabadell
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Palma de Mallorca
country: Spain
facility: Pfizer Investigational Site
state: Islas Baleares
city: La Laguna
country: Spain
facility: Pfizer Investigational Site
state: Santa Cruz de Tenerife
city: Dos Hermanas
country: Spain
facility: Pfizer Investigational Site
state: Sevilla
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: La Coruña
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Malaga
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Genolier
country: Switzerland
facility: Pfizer Investigational Site
city: Gwei Shan Township
country: Taiwan
facility: Pfizer Investigational Site
state: Taoyuan County
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Tainan
country: Taiwan
facility: Pfizer Investigational Site
city: Pathumwan
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Amphoe Mueang
country: Thailand
facility: Pfizer Investigational Site
state: Chiang Mai
city: Bangkok
country: Thailand
facility: Pfizer Investigational Site
city: Bebington, Wirral
country: United Kingdom
facility: Pfizer Investigational Site
city: Cambridge
country: United Kingdom
facility: Pfizer Investigational Site
city: Derby
country: United Kingdom
facility: Pfizer Investigational Site
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
city: Keighley, West Yorkshire
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Peterborough
country: United Kingdom
facility: Pfizer Investigational Site
city: Rhyl, Denbigshire
country: United Kingdom
facility: Pfizer Investigational Site
city: Sheffield
country: United Kingdom
facility: Pfizer Investigational Site
city: Southampton
country: United Kingdom
facility: Pfizer Investigational Site
city: Yeovil, Somerset
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: