Clinical trial NCT00254891: Trial of Paclitaxel/Carboplatin + PF-3512676 vs Paclitaxel/Carboplatin Alone in Patients With Advanced Non-Small Cell Lung Cancer
Official title: International, Randomized, Open-Label, Phase 3 Trial of Paclitaxel/Carboplatin Plus PF-3512676 Versus Paclitaxel/Carboplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: advanced carcinoma, non-small cell lung, Phase III, Paclitaxel, Taxol, Carboplatin, Paraplatin, PF-3512676, immunotherapy, immune modulator
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-11-17
Enrollment: 828
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: To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel/carboplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of paclitaxel

Detailed description: PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the trial, citing lack of efficacy concerns as the primary reason with a safety issue (sepsis) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 17 July 2008.

Eligibility criteria: Inclusion Criteria:

* Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV
* No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC)with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs
* Eastern Cooperative Oncology Performance Status (ECOG PS) 0 or 1

Exclusion Criteria:

* Small cell or carcinoid lung cancer
* Known Central Nervous System (CNS) metastasis
* Pre-existing auto-immune or antibody mediated diseases

Primary outcomes:
measure: Overall Survival
timeFrame: 656 Events
Secondary outcomes:
measure: Overall Objective Response
timeFrame: End of Treatment
measure: Time to Tumor Progression
timeFrame: Time of progressive disease
measure: Progression Free Survival
timeFrame: Time of primary endpoint
measure: Duration of Response
timeFrame: Time of progressive disease
measure: Patient Reported Outcomes
timeFrame: End of Treatment
measure: Overall Safety Profile
timeFrame: 28 days post PF-3512676 dosing
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Hot Springs
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Chula Vista
country: United States
facility: Pfizer Investigational Site
state: California
city: La Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Oceanside
country: United States
facility: Pfizer Investigational Site
state: California
city: Palm Springs
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Fayetteville
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Macon
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Tucker
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Rockford
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Jefferson
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: New Albany
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Cedar Rapids
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Dubuque
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Shelbyville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Covington
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Gretna
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Lafayette
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Marrero
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Marrero
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Biddeford
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Brunswick
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Scarborough
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Allegan
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: St. Joseph
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: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Papillion
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: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Ruidoso
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Buffalo
country: United States
facility: Pfizer Investigational Site
state: New York
city: Great Neck
country: United States
facility: Pfizer Investigational Site
state: New York
city: Asheville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Brevard
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Canton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Dover
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Langhorne
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Chattanooga
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Richardson
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Trophy Club
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: WVC
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Burlington
country: United States
facility: Pfizer Investigational Site
state: Vermont
city: Everett
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Kennewick
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Richland
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Albury
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Camperdown
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Randwick
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Pimlico
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Townsville
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Woolloongabba
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Bedford Park
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Toorak Gardens
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: East Melbourne
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: East Ringwood
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Wodonga
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Liège
country: Belgium
facility: Pfizer Investigational Site
city: Moncton
country: Canada
facility: Pfizer Investigational Site
state: New Brunswick
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
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: Dalian, Xigang District
country: China
facility: Pfizer Investigational Site
state: Liaoning
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Nicosia
country: Cyprus
facility: Pfizer Investigational Site
city: Nova Ves Pod Plesi
country: Czech Republic
facility: Pfizer Investigational Site
city: Ostrava-Poruba
country: Czech Republic
facility: Pfizer Investigational Site
city: Usti nad Labem
country: Czech Republic
facility: Pfizer Investigational Site
city: Angers cedex
country: France
facility: Pfizer Investigational Site
city: Caen cedex
country: France
facility: Pfizer Investigational Site
city: Dijon
country: France
facility: Pfizer Investigational Site
city: Limoges
country: France
facility: Pfizer Investigational Site
city: Nantes Cedex 2
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 13
country: France
facility: Pfizer Investigational Site
city: St Herblain Cedex
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Toulouse cedex 9
country: France
facility: Pfizer Investigational Site
city: Vandoeuvre Les Nancy
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bielefeld
country: Germany
facility: Pfizer Investigational Site
city: Bonn
country: Germany
facility: Pfizer Investigational Site
city: Essen
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt
country: Germany
facility: Pfizer Investigational Site
city: Karlsruhe
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
state: Attica
city: Heraklion
country: Greece
facility: Pfizer Investigational Site
state: Crete
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
state: Macedonia
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Rio, Patras
country: Greece
facility: Pfizer Investigational Site
city: Pokfulam
country: Hong Kong
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Debrecen
country: Hungary
facility: Pfizer Investigational Site
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Kochi
country: India
facility: Pfizer Investigational Site
state: Kerala
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Chandigarh
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Jaipur
country: India
facility: Pfizer Investigational Site
state: Rajasthan
city: Zerifin
country: Israel
facility: Pfizer Investigational Site
city: Lido di Camaiore (LU)
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Pavia
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: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Puebla
country: Mexico
facility: Pfizer Investigational Site
city: Tiel
country: Netherlands
facility: Pfizer Investigational Site
state: GLD
city: Groningen
country: Netherlands
facility: Pfizer Investigational Site
state: GR
city: Amstelveen
country: Netherlands
facility: Pfizer Investigational Site
city: Den Haag
country: Netherlands
facility: Pfizer Investigational Site
city: Otwock
country: Poland
facility: Pfizer Investigational Site
city: Wodzislaw Sl.
country: Poland
facility: Pfizer Investigational Site
city: Faro
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Vila Nova de Gaia
country: Portugal
facility: Pfizer Investigational Site
city: Parktown
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
city: Badalona
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Alcorcon
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Pamplona
country: Spain
facility: Pfizer Investigational Site
state: Navarra
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Santa Cruz de Tenerife
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Uppsala
country: Sweden
facility: Pfizer Investigational Site
city: Lausanne
country: Switzerland
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Truro
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Exeter
country: United Kingdom
facility: Pfizer Investigational Site
state: Devon
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Portsmouth
country: United Kingdom
facility: Pfizer Investigational Site
city: Sheffield
country: United Kingdom
facility: Pfizer Investigational Site
city: Surrey GU2 5XX
country: United Kingdom
facility: Pfizer Investigational Site
city: Swansea
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: