Carcinoma, Non-Small-Cell Lung Clinical Trial
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
Verified date | March 2015 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 828 |
Est. completion date | July 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Pfizer Investigational Site | Albury | New South Wales |
Australia | Pfizer Investigational Site | Bedford Park | South Australia |
Australia | Pfizer Investigational Site | Camperdown | New South Wales |
Australia | Pfizer Investigational Site | East Melbourne | Victoria |
Australia | Pfizer Investigational Site | East Ringwood | Victoria |
Australia | Pfizer Investigational Site | Nedlands | Western Australia |
Australia | Pfizer Investigational Site | Pimlico | Queensland |
Australia | Pfizer Investigational Site | Randwick | New South Wales |
Australia | Pfizer Investigational Site | Toorak Gardens | South Australia |
Australia | Pfizer Investigational Site | Townsville | Queensland |
Australia | Pfizer Investigational Site | Wodonga | Victoria |
Australia | Pfizer Investigational Site | Woolloongabba | Queensland |
Belgium | Pfizer Investigational Site | Gent | |
Belgium | Pfizer Investigational Site | Liège | |
Canada | Pfizer Investigational Site | Moncton | New Brunswick |
Canada | Pfizer Investigational Site | Montreal | Quebec |
Canada | Pfizer Investigational Site | Montreal | Quebec |
Canada | Pfizer Investigational Site | Montreal | Quebec |
Canada | Pfizer Investigational Site | Montreal | Quebec |
Canada | Pfizer Investigational Site | Rimouski | Quebec |
Canada | Pfizer Investigational Site | Saskatoon | Saskatchewan |
China | Pfizer Investigational Site | Beijing | |
China | Pfizer Investigational Site | Beijing | |
China | Pfizer Investigational Site | Dalian, Xigang District | Liaoning |
China | Pfizer Investigational Site | Shanghai | |
Cyprus | Pfizer Investigational Site | Nicosia | |
Czech Republic | Pfizer Investigational Site | Nova Ves Pod Plesi | |
Czech Republic | Pfizer Investigational Site | Ostrava-Poruba | |
Czech Republic | Pfizer Investigational Site | Usti nad Labem | |
France | Pfizer Investigational Site | Angers cedex | |
France | Pfizer Investigational Site | Caen cedex | |
France | Pfizer Investigational Site | Dijon | |
France | Pfizer Investigational Site | Limoges | |
France | Pfizer Investigational Site | Nantes Cedex 2 | |
France | Pfizer Investigational Site | Paris Cedex 13 | |
France | Pfizer Investigational Site | St Herblain Cedex | |
France | Pfizer Investigational Site | Strasbourg | |
France | Pfizer Investigational Site | Toulouse cedex 9 | |
France | Pfizer Investigational Site | Vandoeuvre Les Nancy | |
Germany | Pfizer Investigational Site | Berlin | |
Germany | Pfizer Investigational Site | Bielefeld | |
Germany | Pfizer Investigational Site | Bonn | |
Germany | Pfizer Investigational Site | Essen | |
Germany | Pfizer Investigational Site | Frankfurt | |
Germany | Pfizer Investigational Site | Karlsruhe | |
Germany | Pfizer Investigational Site | Muenchen | |
Greece | Pfizer Investigational Site | Athens | Attica |
Greece | Pfizer Investigational Site | Athens | |
Greece | Pfizer Investigational Site | Heraklion | Crete |
Greece | Pfizer Investigational Site | Rio, Patras | |
Greece | Pfizer Investigational Site | Thessaloniki | Macedonia |
Hong Kong | Pfizer Investigational Site | Pokfulam | |
Hungary | Pfizer Investigational Site | Budapest | |
Hungary | Pfizer Investigational Site | Budapest | |
Hungary | Pfizer Investigational Site | Budapest | |
Hungary | Pfizer Investigational Site | Debrecen | |
India | Pfizer Investigational Site | Bangalore | Karnataka |
India | Pfizer Investigational Site | Chandigarh | Punjab |
India | Pfizer Investigational Site | Jaipur | Rajasthan |
India | Pfizer Investigational Site | Kochi | Kerala |
India | Pfizer Investigational Site | Pune | Maharashtra |
Israel | Pfizer Investigational Site | Zerifin | |
Italy | Pfizer Investigational Site | Lido di Camaiore (LU) | |
Italy | Pfizer Investigational Site | Milano | |
Italy | Pfizer Investigational Site | Napoli | |
Italy | Pfizer Investigational Site | Pavia | |
Korea, Republic of | Pfizer Investigational Site | Seoul | |
Korea, Republic of | Pfizer Investigational Site | Seoul | |
Mexico | Pfizer Investigational Site | Mexico | DF |
Mexico | Pfizer Investigational Site | Puebla | |
Netherlands | Pfizer Investigational Site | Amstelveen | |
Netherlands | Pfizer Investigational Site | Den Haag | |
Netherlands | Pfizer Investigational Site | Groningen | GR |
Netherlands | Pfizer Investigational Site | Tiel | GLD |
Poland | Pfizer Investigational Site | Otwock | |
Poland | Pfizer Investigational Site | Wodzislaw Sl. | |
Portugal | Pfizer Investigational Site | Faro | |
Portugal | Pfizer Investigational Site | Porto | |
Portugal | Pfizer Investigational Site | Porto | |
Portugal | Pfizer Investigational Site | Vila Nova de Gaia | |
South Africa | Pfizer Investigational Site | Cape Town | |
South Africa | Pfizer Investigational Site | Cape Town | |
South Africa | Pfizer Investigational Site | Johannesburg | |
South Africa | Pfizer Investigational Site | Parktown | Gauteng |
Spain | Pfizer Investigational Site | Alcorcon | Madrid |
Spain | Pfizer Investigational Site | Badalona | Barcelona |
Spain | Pfizer Investigational Site | Madrid | |
Spain | Pfizer Investigational Site | Madrid | |
Spain | Pfizer Investigational Site | Pamplona | Navarra |
Spain | Pfizer Investigational Site | Santa Cruz de Tenerife | |
Spain | Pfizer Investigational Site | Valencia | |
Sweden | Pfizer Investigational Site | Stockholm | |
Sweden | Pfizer Investigational Site | Uppsala | |
Switzerland | Pfizer Investigational Site | Lausanne | |
Taiwan | Pfizer Investigational Site | Taipei | |
United Kingdom | Pfizer Investigational Site | Exeter | Devon |
United Kingdom | Pfizer Investigational Site | London | |
United Kingdom | Pfizer Investigational Site | Portsmouth | |
United Kingdom | Pfizer Investigational Site | Sheffield | |
United Kingdom | Pfizer Investigational Site | Surrey GU2 5XX | |
United Kingdom | Pfizer Investigational Site | Swansea | |
United Kingdom | Pfizer Investigational Site | Truro | Cornwall |
United States | Pfizer Investigational Site | Albuquerque | New Mexico |
United States | Pfizer Investigational Site | Allegan | Michigan |
United States | Pfizer Investigational Site | Ann Arbor | Michigan |
United States | Pfizer Investigational Site | Ann Arbor | Michigan |
United States | Pfizer Investigational Site | Arlington | Texas |
United States | Pfizer Investigational Site | Asheville | North Carolina |
United States | Pfizer Investigational Site | Atlanta | Georgia |
United States | Pfizer Investigational Site | Atlanta | Georgia |
United States | Pfizer Investigational Site | Atlanta | Georgia |
United States | Pfizer Investigational Site | Atlanta | Georgia |
United States | Pfizer Investigational Site | Atlanta | Georgia |
United States | Pfizer Investigational Site | Biddeford | Maine |
United States | Pfizer Investigational Site | Bountiful | Utah |
United States | Pfizer Investigational Site | Brevard | North Carolina |
United States | Pfizer Investigational Site | Brunswick | Maine |
United States | Pfizer Investigational Site | Buffalo | New York |
United States | Pfizer Investigational Site | Burlington | Vermont |
United States | Pfizer Investigational Site | Canton | Ohio |
United States | Pfizer Investigational Site | Cedar Rapids | Iowa |
United States | Pfizer Investigational Site | Chattanooga | Tennessee |
United States | Pfizer Investigational Site | Chula Vista | California |
United States | Pfizer Investigational Site | Columbus | Mississippi |
United States | Pfizer Investigational Site | Corinth | Mississippi |
United States | Pfizer Investigational Site | Covington | Louisiana |
United States | Pfizer Investigational Site | Dallas | Texas |
United States | Pfizer Investigational Site | Dallas | Texas |
United States | Pfizer Investigational Site | Dallas | Texas |
United States | Pfizer Investigational Site | Dallas | Texas |
United States | Pfizer Investigational Site | Dallas | Texas |
United States | Pfizer Investigational Site | Decatur | Georgia |
United States | Pfizer Investigational Site | Dover | Ohio |
United States | Pfizer Investigational Site | Dubuque | Iowa |
United States | Pfizer Investigational Site | Everett | Washington |
United States | Pfizer Investigational Site | Fayetteville | Georgia |
United States | Pfizer Investigational Site | Great Neck | New York |
United States | Pfizer Investigational Site | Gretna | Louisiana |
United States | Pfizer Investigational Site | Hot Springs | Arkansas |
United States | Pfizer Investigational Site | Jefferson | Indiana |
United States | Pfizer Investigational Site | Kalamazoo | Michigan |
United States | Pfizer Investigational Site | Kalamazoo | Michigan |
United States | Pfizer Investigational Site | Kennewick | Washington |
United States | Pfizer Investigational Site | La Mesa | California |
United States | Pfizer Investigational Site | Lafayette | Louisiana |
United States | Pfizer Investigational Site | Langhorne | Pennsylvania |
United States | Pfizer Investigational Site | Las Vegas | Nevada |
United States | Pfizer Investigational Site | Las Vegas | Nevada |
United States | Pfizer Investigational Site | Layton | Utah |
United States | Pfizer Investigational Site | Lexington | North Carolina |
United States | Pfizer Investigational Site | Lexington | Kentucky |
United States | Pfizer Investigational Site | Little Rock | Alaska |
United States | Pfizer Investigational Site | Louisville | Kentucky |
United States | Pfizer Investigational Site | Louisville | Kentucky |
United States | Pfizer Investigational Site | Louisville | Kentucky |
United States | Pfizer Investigational Site | Louisville | Kentucky |
United States | Pfizer Investigational Site | Macon | Georgia |
United States | Pfizer Investigational Site | Madison | Wisconsin |
United States | Pfizer Investigational Site | Marietta | Georgia |
United States | Pfizer Investigational Site | Marrero | Louisiana |
United States | Pfizer Investigational Site | Marrero | Louisiana |
United States | Pfizer Investigational Site | Memphis | Tennessee |
United States | Pfizer Investigational Site | Metairie | Louisiana |
United States | Pfizer Investigational Site | Murray | Utah |
United States | Pfizer Investigational Site | New Albany | Indiana |
United States | Pfizer Investigational Site | New Orleans | Louisiana |
United States | Pfizer Investigational Site | Oceanside | California |
United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
United States | Pfizer Investigational Site | Omaha | Nebraska |
United States | Pfizer Investigational Site | Omaha | Nebraska |
United States | Pfizer Investigational Site | Omaha | Nebraska |
United States | Pfizer Investigational Site | Palm Springs | California |
United States | Pfizer Investigational Site | Papillion | Nebraska |
United States | Pfizer Investigational Site | Portland | Oregon |
United States | Pfizer Investigational Site | Provo | Utah |
United States | Pfizer Investigational Site | Richardson | Texas |
United States | Pfizer Investigational Site | Richland | Washington |
United States | Pfizer Investigational Site | Rockford | Illinois |
United States | Pfizer Investigational Site | Ruidoso | New Mexico |
United States | Pfizer Investigational Site | Salt Lake City | Utah |
United States | Pfizer Investigational Site | San Diego | California |
United States | Pfizer Investigational Site | San Francisco | California |
United States | Pfizer Investigational Site | Scarborough | Maine |
United States | Pfizer Investigational Site | Shelbyville | Kentucky |
United States | Pfizer Investigational Site | St. Joseph | Michigan |
United States | Pfizer Investigational Site | Trophy Club | Texas |
United States | Pfizer Investigational Site | Tucker | Georgia |
United States | Pfizer Investigational Site | Tupelo | Mississippi |
United States | Pfizer Investigational Site | Winston-Salem | North Carolina |
United States | Pfizer Investigational Site | Worcester | Massachusetts |
United States | Pfizer Investigational Site | WVC | Utah |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Australia, Belgium, Canada, China, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | 656 Events | No | |
Secondary | Overall Objective Response | End of Treatment | No | |
Secondary | Time to Tumor Progression | Time of progressive disease | No | |
Secondary | Progression Free Survival | Time of primary endpoint | No | |
Secondary | Duration of Response | Time of progressive disease | No | |
Secondary | Patient Reported Outcomes | End of Treatment | No | |
Secondary | Overall Safety Profile | 28 days post PF-3512676 dosing | Yes |
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