A Study Comparing Two Different Chemotherapy Types in Chinese Patients With Advanced Non Small Cell Lung Cancer
NCT ID: NCT01005680
Last Updated: 2013-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
256 participants
INTERVENTIONAL
2009-11-30
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pemetrexed plus Cisplatin
Pemetrexed
500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin
75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles
Gemcitabine plus Cisplatin
Gemcitabine
1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin
75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles
Interventions
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Pemetrexed
500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gemcitabine
1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin
75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug.
* Female participants must not be pregnant.
* No prior systemic chemotherapy for lung cancer.
* At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors.
* Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
* Adequate organ function.
* Prior radiation therapy allowed to \<25% of the bone marrow.
* Signed informed consent document on file.
* Estimated life expectancy of greater than or equal to 12 weeks.
* Participant compliance and geographic proximity that allow adequate follow up.
Exclusion Criteria
* Inability to comply with protocol or study procedures.
* A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the participant's ability to complete the study.
* A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.
* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
* Documented brain metastases unless the participant has completed successful local therapy for central nervous system metastases and has not taken corticosteroids for at least 4 weeks before enrollment.
* Presence of clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
* Significant weight loss (that is, greater than or equal to 10%) over the previous 6 weeks before study entry.
* Concurrent administration of any other anti-tumor therapy.
* Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents, such as piroxicam).
* Inability or unwillingness to take folic acid or vitamin B12 supplementation.
* Inability to take corticosteroids.
* Pregnant or breast-feeding.
* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Beijing, , China
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Changchun, , China
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dalian, , China
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Guangzhou, , China
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nanjing, , China
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nanning, , China
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shanghai, , China
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sichuan, , China
Countries
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Other Identifiers
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H3E-CR-JMIL
Identifier Type: OTHER
Identifier Source: secondary_id
12878
Identifier Type: -
Identifier Source: org_study_id