Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC
NCT ID: NCT00254904
Last Updated: 2015-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
839 participants
INTERVENTIONAL
2005-11-30
2008-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer
NCT00907504
Surgery, Gemcitabine, Cisplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer
NCT00530634
Gemcitabine, Cisplatin, and Gefitinib in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer
NCT00103051
Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin
NCT00055965
Neo-Adjuvant Gemcitabine and Cisplatin in Treating Patients With Early Stage of Non Small Cell Lung Cancer
NCT00191763
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
Standard of Care chemotherapy plus experimental intervention (PF-3512676)
Cisplatin
Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles
Gemcitabine
Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
PF-3512676
PF-3512676 0.2 mg/kg subcutaneously days 8 and 15 x 6 cycles and then weekly until disease progression or unacceptable toxicity
B
Standard of Care chemotherapy
Cisplatin
Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles
Gemcitabine + Cisplatin
Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cisplatin
Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles
Gemcitabine
Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
PF-3512676
PF-3512676 0.2 mg/kg subcutaneously days 8 and 15 x 6 cycles and then weekly until disease progression or unacceptable toxicity
Cisplatin
Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles
Gemcitabine + Cisplatin
Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Known Central Nervous System (CNS) metastasis
* Pre-existing auto-immune or antibody mediated diseases
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pfizer Inc
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Bakersfield, California, United States
Pfizer Investigational Site
Saint Joseph, Michigan, United States
Pfizer Investigational Site
Minneapolis, Minnesota, United States
Pfizer Investigational Site
St Louis, Missouri, United States
Pfizer Investigational Site
St Louis, Missouri, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Spokane, Washington, United States
Pfizer Investigational Site
Spokane, Washington, United States
Pfizer Investigational Site
Innsbruck, , Austria
Pfizer Investigational Site
Brussels, , Belgium
Pfizer Investigational Site
Brussels, , Belgium
Pfizer Investigational Site
Charleroi, , Belgium
Pfizer Investigational Site
Hasselt, , Belgium
Pfizer Investigational Site
Jette, , Belgium
Pfizer Investigational Site
Leuven, , Belgium
Pfizer Investigational Site
Liège, , Belgium
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, Brazil
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, Brazil
Pfizer Investigational Site
Jaú, São Paulo, Brazil
Pfizer Investigational Site
Jaú, São Paulo, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Windsor, Ontario, Canada
Pfizer Investigational Site
Windsor, Ontario, Canada
Pfizer Investigational Site
Greenfield Park, Quebec, Canada
Pfizer Investigational Site
Laval, Quebec, Canada
Pfizer Investigational Site
Lévis, Quebec, Canada
Pfizer Investigational Site
Québec, Quebec, Canada
Pfizer Investigational Site
Guangzhou, Guangdong, China
Pfizer Investigational Site
Nanjing, Jiangsu, China
Pfizer Investigational Site
Dalian, Liaoning, China
Pfizer Investigational Site
Beijing, , China
Pfizer Investigational Site
Beijing, , China
Pfizer Investigational Site
Prague, CZ, Czechia
Pfizer Investigational Site
Olomouc, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Bielefeld, , Germany
Pfizer Investigational Site
Karlsruhe, , Germany
Pfizer Investigational Site
Löwenstein, , Germany
Pfizer Investigational Site
Mannheim, , Germany
Pfizer Investigational Site
München, , Germany
Pfizer Investigational Site
Tübingen, , Germany
Pfizer Investigational Site
Kowloon, , Hong Kong
Pfizer Investigational Site
Shatin, , Hong Kong
Pfizer Investigational Site
Zalaegerszeg, Külsőkórház-Pózva, Hungary
Pfizer Investigational Site
Budapest, , Hungary
Pfizer Investigational Site
Deszk, , Hungary
Pfizer Investigational Site
Gyula, , Hungary
Pfizer Investigational Site
Pécs, , Hungary
Pfizer Investigational Site
Bangalore, Karnataka, India
Pfizer Investigational Site
Kochi, Kerala, India
Pfizer Investigational Site
Pune, Maharashtra, India
Pfizer Investigational Site
New Delhi, New Delhi, India
Pfizer Investigational Site
Ludhiana, Punjab, India
Pfizer Investigational Site
Lucknow, Uttar Pradesh, India
Pfizer Investigational Site
Beersheba, , Israel
Pfizer Investigational Site
Kfar Saba, , Israel
Pfizer Investigational Site
Forlì, , Italy
Pfizer Investigational Site
Milan, , Italy
Pfizer Investigational Site
Pisa, , Italy
Pfizer Investigational Site
Roma, , Italy
Pfizer Investigational Site
S.Andrea Delle Fratte (PG), , Italy
Pfizer Investigational Site
Amsterdam, North Holland, Netherlands
Pfizer Investigational Site
Zaandam, North Holland, Netherlands
Pfizer Investigational Site
's-Hertogenbosch, , Netherlands
Pfizer Investigational Site
Harderwijk, , Netherlands
Pfizer Investigational Site
Nijmegen, , Netherlands
Pfizer Investigational Site
Gdansk, , Poland
Pfizer Investigational Site
Lodz, , Poland
Pfizer Investigational Site
Otwock, , Poland
Pfizer Investigational Site
Szczecin-Zdunowo, , Poland
Pfizer Investigational Site
Warsaw, , Poland
Pfizer Investigational Site
Warsaw, , Poland
Pfizer Investigational Site
Warsaw, , Poland
Pfizer Investigational Site
Wodzislaw Sl., , Poland
Pfizer Investigational Site
Coimbra, , Portugal
Pfizer Investigational Site
Lisbon, , Portugal
Pfizer Investigational Site
Lisbon, , Portugal
Pfizer Investigational Site
Lisbon, , Portugal
Pfizer Investigational Site
Porto, , Portugal
Pfizer Investigational Site
Singapore, Singapore, Singapore
Pfizer Investigational Site
Bratislava, , Slovakia
Pfizer Investigational Site
Košice, , Slovakia
Pfizer Investigational Site
Kvetnica Pri Poprade, , Slovakia
Pfizer Investigational Site
Nitra-Zobor, , Slovakia
Pfizer Investigational Site
Port Elizabeth, Eastern Cape, South Africa
Pfizer Investigational Site
Cape Town, , South Africa
Pfizer Investigational Site
Port Elizabeth, , South Africa
Pfizer Investigational Site
Gyeonggi-do, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Alicante, Alicante, Spain
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, Spain
Pfizer Investigational Site
Santander, Cantabria, Spain
Pfizer Investigational Site
Castellon, Castellon, Spain
Pfizer Investigational Site
Girona, Gerona, Spain
Pfizer Investigational Site
Jaén, Jaen, Spain
Pfizer Investigational Site
Barakaldo, Vizcaya, Spain
Pfizer Investigational Site
Taichung, , Taiwan
Pfizer Investigational Site
Tainan City, , Taiwan
Pfizer Investigational Site
Taipei, , Taiwan
Pfizer Investigational Site
Taipei, , Taiwan
Pfizer Investigational Site
Ankara, , Turkey (Türkiye)
Pfizer Investigational Site
Bornova / Izmir, , Turkey (Türkiye)
Pfizer Investigational Site
Istanbul / Ceraahpasa, , Turkey (Türkiye)
Pfizer Investigational Site
Bristol, Avon, United Kingdom
Pfizer Investigational Site
Southampton, Hampshire, United Kingdom
Pfizer Investigational Site
Sutton, Surrey, United Kingdom
Pfizer Investigational Site
Belfast, , United Kingdom
Pfizer Investigational Site
Dundee, , United Kingdom
Pfizer Investigational Site
Edinburgh, , United Kingdom
Pfizer Investigational Site
Glasgow, , United Kingdom
Pfizer Investigational Site
Leicester, , United Kingdom
Pfizer Investigational Site
London, , United Kingdom
Pfizer Investigational Site
Wolverhampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A8501002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.