Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC
NCT00254904
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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 Group Performance Status (ECOG PS) 0 or 1
- Small cell or carcinoid lung cancer
- Known Central Nervous System (CNS) metastasis
- Pre-existing auto-immune or antibody mediated diseases
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Las Vegas, Nevada
- Camperdown, New South Wales
- Fresno, California
- Glendale, California
- Long Beach, California
- Los Angeles, California
- Santa Ana, California
- Whittier, California
- Whittier, California
- Greenbrae, California
- La Jolla, California
- LaJolla, California
- San Diego, California
- San Mateo, California
- Tampa, Florida
- Ann Arbor, Michigan
- Detroit, Michigan
- Farmington Hills, Michigan
- Coon Rapids, Minnesota
- Fridley, Minnesota
- Robbinsdale, Minnesota
- New York, New York
- Philadelphia, Pennsylvania
- Baltimore, Maryland
- St. Louis, Missouri
- St. Louis, Missouri
- St. Peters, Missouri
- Chapel Hill, North Carolina
- Clinton, North Carolina
- Goldsboro, North Carolina
- Pollocksville, North Carolina
- Wilson, North Carolina
- Pittsburgh, Pennsylvania
- Charlottesville, Virginia
- Orbassano (Torino),
- Badalona, Barcelona
- Barcelona,
- Birmingham, Alabama
- Birmingham, Alabama
- Little Rock, Arkansas
- Bakersfield, California
- Beverly Hills, California
- Beverly Hills, California
- La Jolla, California
- La Jolla, California
- Los Angeles, California
- Los Angeles, California
- Los Angeles, California
- Los Angeles, California
- Orange, California
- Orange, California
- Palo Alto, California
- Sacramento, California
- Sacramento, California
- San Diego, California
- Santa Monica, California
- Santa Monica, California
- Santa Monica, California
- Santa Rosa, California
- Aurora, Colorado
- Aurora, Colorado
- Aurora, Colorado
- Denver, Colorado
- Lafayette, Colorado
- New Haven, Connecticut
- New Haven, Connecticut
- New Haven, Connecticut
- Fort Lauderdale, Florida
- Hollywood, Florida
- Lake Worth, Florida
- Pembroke Pines, Florida
- Tampa, Florida
- Atlanta, Georgia
- Atlanta, Georgia
- Atlanta, Georgia
- Atlanta, Georgia
- Atlanta, Georgia
- Atlanta, Georgia
- Augusta, Georgia
- Augusta, Georgia
- Augusta, Georgia
- Decatur, Georgia
- Macon, Georgia
- Marietta, Georgia
- Sandy Springs, Georgia
- Honolulu, Hawaii
- Honolulu, Hawaii
- Honolulu, Hawaii
- Chicago, Illinois
- Chicago, Illinois
- Chicago, Illinois
- Harvey, Illinois
- Harvey, Illinois
- Harvey, Illinois
- Tinley Park, Illinois
- Indianapolis, Indiana
- Indianapolis, Indiana
- Indianapolis, Indiana
- Indianapolis, Indiana
- Indianopolis, Indiana
- Munster, Indiana
- Munster, Indiana
- Baltimore, Maryland
- Baltimore, Maryland
- Bethesda, Maryland
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Detroit, Michigan
- Farmington Hills, Michigan
- St. Louis, Missouri
- St. Louis, Missouri
- St. Peters, Missouri
- Omaha, Nebraska
- Lebanon, New Hampshire
- Albuquerque, New Mexico
- Albuquerque, New Mexico
- Lake Success, New York
- Manhasset, New York
- New Hyde Park, New York
- New York, New York
- New York, New York
- New York, New York
- New York, New York
- Oneida, New York
- Oswego, New York
- Syracuse, New York
- Syracuse, New York
- Chapel Hill, North Carolina
- Chapel Hill, North Carolina
- Charlotte, North Carolina
- Huntersville, North Carolina
- Huntersville, North Carolina
- Matthews, North Carolina
- Cleveland, Ohio
- Columbus, Ohio
- Columbus, Ohio
- Columbus, Ohio
- Columbus, Ohio
- Portland, Oregon
- Hershey, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- East Providence, Rhode Island
- East Providence, Rhode Island
- Charleston, South Carolina
- Dickson, Tennessee
- Franklin, Tennessee
- Gallatin, Tennessee
- Hermitage, Tennessee
- Lebanon, Tennessee
- Murfreesboro, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Smyrna, Tennessee
- Dallas, Texas
- Dallas, Texas
- Dallas, Texas
- Dallas, Texas
- Houston, Texas
- Seattle, Washington
- Seattle, Washington
- Seattle, Washington
- Seattle, Washington
- Seattle, Washington
- Camperdown, New South Wales
- Adelaide, South Australia
- East Melbourne, Victoria
- Nedlands, Western Australia
- Salvador, Bahia
- Rio de Janeiro, RJ
- Ijui, RS
- Porto Alegre, RS
- Porto Alegre, RS
- Jau, Sao Paulo
- Barretos, SP
- Sao Paulo, SP
- Sao Paulo, SP
- Sofia,
- Sofia,
- Sofia,
- Varna,
- Calgary, Alberta
- Calgary, Alberta
- Calgary, Alberta
- Edmonton, Alberta
- Moncton, New Brunswick
- Moncton, New Brunswick
- Oshawa, Ontario
- Oshawa, Ontario
- Ottawa, Ontario
- Montreal, Quebec
- Montreal, Quebec
- Montreal, Quebec
- Montreal, Quebec
- Montreal, Quebec
- Guangzhou, Guangdong
- Nanjing, Jiangsu
- Beijing,
- Beijing,
- Guangzhou,
- Shanghai,
- Shanghai,
- Shanghai,
- Shanghai,
- Caen Cedex 05,
- Dijon,
- Grenoble Cedex 09,
- Marseille Cedex 20,
- NICE Cedex 2,
- Paris cedex 20,
- Paris,
- St Herblain Cedex,
- Villejuif,
- Dresden,
- Essen,
- Grosshansdorf,
- Hamburg,
- Heidelberg,
- Koeln,
- Muenchen,
- Oldenburg,
- Wiesbaden,
- Heraklion, Crete
- Exohi, Thessaloniki
- Athens,
- Pokfulam,
- Shatin, New Territories,
- Tuen Mun, New Territories,
- Budapest,
- Budapest,
- Debrecen,
- Farkasgyepu,
- Szekesfehervar,
- Torokbalint,
- Dublin,
- Dublin,
- Galway,
- Galway,
- Galway,
- Avellino,
- Firenze,
- Genova,
- Lido di Camaiore (LU),
- Lucca,
- Milano,
- Milano,
- Milano,
- Milano,
- Monza,
- Orbassano (TO),
- Perugia,
- Roma,
- Torino,
- Nagoya, Aichi
- Sapporo, Hokkaido
- Akashi, Hyogo
- Osakasayama-shi, Osaka
- Sunto-gun, Shizuoka
- Chuo-ku, Tokyo
- Fukuoka,
- Kashiwa,
- Okayama,
- Tokyo,
- Gyeonggi-do,
- Seoul,
- Seoul,
- Groningen,
- Gdansk,
- Olsztyn,
- Olsztyn,
- Olsztyn,
- Olsztyn,
- Poznan,
- Poznan,
- Kazan,
- Moscow,
- Saint-Petersburg,
- Saint-Petersburg,
- Saint-Petersburg,
- St. Petersburg,
- Oviedo, Asturias
- Badalona, Barcelona
- L'hospitalet de Llobregat, Barcelona
- Sabadell, Barcelona
- A Coruña, Galicia
- Barcelona,
- Barcelona,
- Madrid,
- Pamplona,
- Santander,
- Sevilla,
- Stockholm,
- Tainan,
- Taipei,
- Taipei,
- Headington, Oxford
- Sutton, Surrey
- Eastleigh,
- London,
- London,
- London,
- Manchester,
- Southampton,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC | |||
Official Title ICMJE | International, Randomized, Open-Label, Phase 3 Trial of Gemcitabine/Cisplatin Plus PF-3512676 Versus Gemcitabine/Cisplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer | |||
Brief Summary | To assess the efficacy and safety of PF-3512676 administered in combination with gemcitabine/cisplatin 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 gemcitabine/cisplatin alone. | |||
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 (thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 25 June 2008. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Carcinoma, Non-Small-Cell Lung | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 839 | |||
Original Enrollment ICMJE | 800 | |||
Actual Study Completion Date ICMJE | June 2008 | |||
Actual Primary Completion Date | June 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria, Belgium, Brazil, Canada, China, Czech Republic, Germany, Hong Kong, Hungary, India, Israel, Italy, Korea, Republic of, Netherlands, Poland, Portugal, Singapore, Slovakia, South Africa, Spain, Taiwan, Turkey, United Kingdom, United States | |||
Removed Location Countries | France | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00254904 | |||
Other Study ID Numbers ICMJE | A8501002 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |