A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
NCT ID: NCT00087711
Last Updated: 2019-09-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
1713 participants
Study Classification
INTERVENTIONAL
Study Start Date
2004-07-31
Study Completion Date
2008-03-31
Brief Summary
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This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.
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Detailed Description
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Conditions
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Non Small Cell Lung Carcinoma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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A
Group Type
EXPERIMENTAL
pemetrexed
Intervention Type
DRUG
500 mg/m2, IV q 21 days x 6 cycles
cisplatin
Intervention Type
DRUG
75 mg/m2, IV, q 21 days x 6 cycles
B
Group Type
ACTIVE_COMPARATOR
gemcitabine
Intervention Type
DRUG
1250 mg/m2, IV, day 1 and 8 q 21 days x 6 cycles
cisplatin
Intervention Type
DRUG
75 mg/m2, IV, q 21 days x 6 cycles
Interventions
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pemetrexed
500 mg/m2, IV q 21 days x 6 cycles
Intervention Type
DRUG
gemcitabine
1250 mg/m2, IV, day 1 and 8 q 21 days x 6 cycles
Intervention Type
DRUG
cisplatin
75 mg/m2, IV, q 21 days x 6 cycles
Intervention Type
DRUG
Other Intervention Names
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LY231514
Alimta
LY188011
Gemzar
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of NSCLC Stage IIIB not amenable to curative treatment or Stage IV.
* No prior chemotherapy for lung cancer.
* Patients must have at least one uni-dimensionally measurable lesion.
* Prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. Radiation must be completed at least 4 weeks prior to study enrollment.
* No prior chemotherapy for lung cancer.
* Patients must have at least one uni-dimensionally measurable lesion.
* Prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. Radiation must be completed at least 4 weeks prior to study enrollment.
Exclusion Criteria
* Treatment with any drug within the last 30 days that has not received regulatory approval.
* Serious cardiac condition.
* Serious medical disorder in addition to NSCLC that would make it difficult for the patient to complete the study.
* Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
* Presence of fluid retention that cannot be controlled by drainage.
* Serious cardiac condition.
* Serious medical disorder in addition to NSCLC that would make it difficult for the patient to complete the study.
* Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
* Presence of fluid retention that cannot be controlled by drainage.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Sacramento, California, United States
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Torrance, California, United States
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Jacksonville, Florida, United States
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Macon, Georgia, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Scarborough, Maine, United States
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Duluth, Minnesota, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Hackensack, New Jersey, United States
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Hickory, North Carolina, United States
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Portland, Oregon, United States
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Columbia, South Carolina, United States
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Nashville, Tennessee, United States
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Arlington, Texas, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Bahía Blanca, , Argentina
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Buenos Aires, , Argentina
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Bedford Park, , Australia
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Camperdown, , Australia
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Chermisdie, , Australia
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Fitzroy, , Australia
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Hornsby, , Australia
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Nedlands, , Australia
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South Brisbane, , Australia
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St Leonards, , Australia
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Graz, , Austria
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Grimmenstein, , Austria
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Innsbruck, , Austria
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Leoben, , Austria
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Linz, , Austria
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Sankt Pölten, , Austria
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Vienna, , Austria
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Wels, , Austria
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Leuven, , Belgium
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Liège, , Belgium
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Florianópolis, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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Salvador, , Brazil
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São Paulo, , Brazil
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North Vancouver, British Columbia, Canada
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Brampton, Ontario, Canada
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Toronto, Ontario, Canada
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Sainte-Foy, Quebec, Canada
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Herlev, , Denmark
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Odense, , Denmark
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Helsinki, , Finland
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Tampere, , Finland
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Bordeaux, , France
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Grenoble, , France
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Marseille, , France
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Montpellier, , France
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Paris, , France
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Saint-Herblain, , France
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Strasbourg, , France
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Vandœuvre-lès-Nancy, , France
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Mannheim, , Germany
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Athens, , Greece
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Heraklion, , Greece
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Pátrai, , Greece
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Budapest, , Hungary
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Deszk, , Hungary
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Pécs, , Hungary
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Bangalore, , India
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Hyderabad, , India
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Kochi, , India
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Mumbai, , India
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New Dehli, , India
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Pune, , India
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Kfar Saba, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
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Ancona, , Italy
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Bergamo, , Italy
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Bologna, , Italy
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Forlì, , Italy
Site Status
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Genova, , Italy
Site Status
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Livorno, , Italy
Site Status
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Modena, , Italy
Site Status
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Orbassano, , Italy
Site Status
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Roma, , Italy
Site Status
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Taormina, , Italy
Site Status
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Ciudad Obregón, , Mexico
Site Status
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Guadalajara, , Mexico
Site Status
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León, , Mexico
Site Status
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Mexicali, , Mexico
Site Status
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Mexico City, , Mexico
Site Status
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's-Hertogenbosch, , Netherlands
Site Status
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Alkmaar, , Netherlands
Site Status
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Amstelveen, , Netherlands
Site Status
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Amsterdam, , Netherlands
Site Status
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Arnhem, , Netherlands
Site Status
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Eindhoven, , Netherlands
Site Status
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Harderwijk, , Netherlands
Site Status
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Heerlen, , Netherlands
Site Status
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Krakow, , Poland
Site Status
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Lodz, , Poland
Site Status
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Szczecin-Zdunowo, , Poland
Site Status
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Warsaw, , Poland
Site Status
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Coimbra, , Portugal
Site Status
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Lisbon, , Portugal
Site Status
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Porto, , Portugal
Site Status
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Santa Maria da Feira, , Portugal
Site Status
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San Juan, , Puerto Rico
Site Status
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Goyang-si, , South Korea
Site Status
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Seoul, , South Korea
Site Status
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Alicante, , Spain
Site Status
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Badalona, , Spain
Site Status
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Barcelona, , Spain
Site Status
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Madrid, , Spain
Site Status
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Pamplona, , Spain
Site Status
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Sabadell, , Spain
Site Status
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Santander, , Spain
Site Status
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Zaragoza, , Spain
Site Status
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Gothenburg, , Sweden
Site Status
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Lund, , Sweden
Site Status
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Stockholm, , Sweden
Site Status
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Niao Sung Hsiang, , Taiwan
Site Status
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Taichung, , Taiwan
Site Status
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Taipei, , Taiwan
Site Status
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Taoyuan District, , Taiwan
Site Status
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Ankara, , Turkey (Türkiye)
Site Status
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Antalya, , Turkey (Türkiye)
Site Status
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Istanbul, , Turkey (Türkiye)
Site Status
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Izmir, , Turkey (Türkiye)
Site Status
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Aberdeen, , United Kingdom
Site Status
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Bangor, , United Kingdom
Site Status
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Chelmsford, , United Kingdom
Site Status
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Fulham, , United Kingdom
Site Status
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Plymouth, , United Kingdom
Site Status
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Sutton, , United Kingdom
Site Status
Countries
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United States
Argentina
Australia
Austria
Belgium
Brazil
Canada
Denmark
Finland
France
Germany
Greece
Hungary
India
Israel
Italy
Mexico
Netherlands
Poland
Portugal
Puerto Rico
South Korea
Spain
Sweden
Taiwan
Turkey (Türkiye)
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
Wu YL, Lu S, Cheng Y, Zhou C, Wang M, Qin S, Lu Y, Zhang Y, Zhu Y, Song X, Wang X, Barraclough H, Zhang X, Chi H, Orlando M. Efficacy and safety of pemetrexed/cisplatin versus gemcitabine/cisplatin as first-line treatment in Chinese patients with advanced nonsquamous non-small cell lung cancer. Lung Cancer. 2014 Sep;85(3):401-7. doi: 10.1016/j.lungcan.2014.07.007. Epub 2014 Jul 17.
Reference Type
DERIVED
Gridelli C, Brodowicz T, Langer CJ, Peterson P, Islam M, Guba SC, Moore P, Visseren-Grul CM, Scagliotti G. Pemetrexed therapy in elderly patients with good performance status: analysis of two phase III trials of patients with nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2012 Sep;13(5):340-6. doi: 10.1016/j.cllc.2011.12.002. Epub 2012 Jan 23.
Reference Type
DERIVED
Other Identifiers
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H3E-MC-JMDB
Identifier Type: OTHER
Identifier Source: secondary_id
2938
Identifier Type: -
Identifier Source: org_study_id
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